|Colour||Category||Author||Date||Title||Study Design||Conflict of Interest||Light Source||Device||Wavelength||Time||Frequency/Duration||Distance||Subjects|| Irradiance||Fluence||Main results||Adverse effects|
|Blue||Acne||Gold et al.||2011||Clinical efficacy of home-use blue-light therapy for mild-to-moderate acne||Randomized Split-face Control Trial|
- yes - consultant of the device company
|Tanda Zap (TZ) device (Pharos Life Corporation, a subsidiary of Syneron – Candela, Ontario, Canada)||414 nm||2 min||twice per day for 2 days||not reported|
|not reported||not reported|
- significant improvement in lesion size and erythema after two treatments between those that were treated with the active unit versus lesions treated with the sham device
- overall improvement in lesion condition following only 2 treatments was significantly improved after two treatments
- average time for improvement with the active device was only 29 hours compared with 45 hours for the placebo.
- average time to clearance was 99 hours for the active unit compared to 122 hours with the placebo device
|Acne||Morton et al.||2005||An open study to determine the efficacy of blue light in the treatment of mild to moderate acne||Open clinical trial ||LED (adjustable planar arrays)||Omnilux blue (Phototherapeutics Ltd., UK)||415 nm||20 min|
twice weekly for 4 weeks
|5-10 cm from face|
|40 mW/cm2||48 J/cm2|
- no difference in adverse effects between 10 and 20 min treatments
- average clearance of inflammatory lesions was 64%
- there was no observed reduction in noninflammatory lesions
- minor and self-limiting erythema, dryness and pruritus
|Acne||Tremblay et al.||2006||Light-emitting diode 415 nm in the treatment of inflammatory acne: An open-label, multicentric, pilot investigation||Open clinical trial||LED (adjustable planar arrays)||Omnilux Blue (Photo Therapeutics, UK)||415 nm||20 min|
twice per week
|not reported||48 J/cm2|
Clinical assessment was performed at baseline and 2, 4 and 8 weeks after treatment.
mean improvement score was 3.14 at 4 weeks and 2.90 at 8 weeks.
Nine patients experienced complete clearing at 8 weeks.
The treatment was well tolerated, with 50% of patients highly satisfied with the treatment.
|Acne||Kawada||2002||Acne phototherapy with a high-intensity, enhanced, narrowband, blue light source: an open study and in vitro investigation||Open clinical trial|
400 W metal halide lamp with UV-cut filters; 20x20 cm
|ClearLight, Lumenis, Tokyo||407-420 nm||not reported ||twice per week up to 5 weeks||not reported|
|90 mW/cm2||not reported|
- skin lesions were reduced by 64% at 5 weeks
- 77% of subjects experienced an improvement
- 3 subjects dropped out because of worsening of skin lesions
- durability of at least one month was shown
- effects were stronger on inflammatory lesions than on comedones
- 3 discontinued study because of worsening of skin lesions
- dryness was seen in two patients
|Acne (moderate-severe)||Akaraphanth et al.||2007||Efficacy of ALA-PDT vs blue light in the treatment of acne||Split-face, self-controlled clinical trial||LED (adjustable planar arrays)||Omnilux blue, Photo Therapeutics Ltd., Altrincham, Manchester, UK||415 nm||20 min||weekly for 4 weeks||10 cm|
|40 mW/cm2||48 J/cm2|
- evaluation was performed by counting acne lesions at baseline, 4, 8, 12 and 16 weeks after the beginning of the treatment.
- biophysical measurements included sebum levels and the erythema, and melanin indices
- mean percent reduction in inflamed lesions counts tended to be higher in the ALA-PDT areas; it was 32%, 50.9%, 65.9% and 71.1%, respectively, compared with the blue-light-alone treatment, which was 20.7%, 27%, 57.7% and 56.7%, respectively, but without any statistical significance
- no demonstrable significant change in sebum excretion, erythema or the melanin index after treatment.
- side effects were stronger on the ALA-PDT-treated side (100%)
- Blue light only group: erythema (30%), pruritus (50%), desquamation (60%)
|Hyperpigmentation||Kleinpenning et al.||2010||Clinical and histological effects of blue light on normal skin||Open clinical study|
Waldmann 450L photodynamic therapy lamp
| (Herbert Waldmann GmbH & CO., Villingen-Schwenningen, Germany) ||380- 480 nm (peak 420)||not reported||5 consecutive days||not reported|
|not reported||20 J/cm2 per day; cumulative dose 100 J./cm2|
- Skin biopsies were analyzed with respect to photodamage (p53, vacuolization, sunburn cells), skin aging (elastosis, MMP-1) and melanogenesis (Melan-A).
- No inflammatory cells and sunburn cells were visible before or after irradiation.
- A significant increase in the perinuclear vacuolization of keratinocytes was demonstrated during treatment with a tendency towards significance after cessation of treatment
- No significant change in p53 expression was seen.
- Signs of elastosis and changes in MMP-1 expression were absent.
- Minimal clinical hyperpigmentation of the irradiated skin was confirmed histologically with a significant increase in Melan-A-positive cells (P = 0.03)
- treatment was well tolerated
- one subject showed slight pigmentation after 5 treatments
|Psoriasis||Maari et al.||2003||Repeated exposure to blue light does not improve psoriasis||Open clinical trial||7 fluorescent tubes||(Blue-U, DUSA Pharmaceuticals, NY)||417 nm||not reported||3x/week for 4 weeks||not reported|
|0.0085 W/cm2||10 J/cm2 |
- A single exposure to blue light induced almost complete photobleaching of PpIX.
- There was no significant difference between the mean psoriasis severity score of the plaques before and after 12 exposures to blue light
- well tolerated
- no adverse effects
|Psoriasis (mild)||Pfaff et al.||2015||Prospective Randomized Long-Term Study on the Efficacy and Safety of UV-Free Blue Light for Treating Mild Psoriasis Vulgaris||Open clinical trial|
- yes - funded by device company
|Philips Light and Health, Netherlands||453 nm||30 min||3-4 times per week for 12 weeks|
|90 J/cm2 |
- significant improvement in targeted plaque compared to control
- greater efficacy of high-intensity treatment
- 16.7% of patients did not benefit
- 16.7% achieved a reduction greater than 75%
- the majority achieved a reduction between 25-75%
- very high level of patient satisfaction
- daily treatment dose was the same in both groups and the variation in intensity had only a minor effect on efficacy
- no serious adverse events
- 50% of patients reported subjective hyperpigmentation of the skin surrounding the treatment area that disappeared spontaneously after trial period
(mild to moderate)
|Weinstabl et al.||2011||Prospective Randomized Study on the Efficacy of Blue Light in the Treatment of Psoriasis Vulgaris||Randomized study|
- yes - funded by device company
|Philips Technologie |
|15 min||daily for 4 weeks||directly on skin||n=40 (20 per group)||100 mW/cm2||90 J/cm2|
- statistically significant improvement after 4 weeks of treatment in both groups
- plaque status as assessed by both the physicians and the patients improved continuously during the 4 weeks of treatment and steadily declined thereafter.
- hyperpigmentation after 3 weeks of treatment that decreased after the treatment period
|Skin rejuvenation||Nikolis et al.||2016||A randomized, placebo-controlled, single-blinded, split-faced clinical trial evaluating the efficacy and safety of KLOX-001 gel formulation with KLOX light-emitting diode light on facial rejuvenation||SB- RCT|
- yes - authors are consultants or employee of device company
KLOX LED light
|446 nm||5 min/||once per week for 4 weeks||5 cm distance|
|150 mW/cm2||not reported|
- KLOX LED light with placebo gel and KLOX LED light + KLOX-001 gel groups were superior to standard of care and placebo LED on subjective clinical assessment and multiple wrinkles scales, with statistically significant results obtained for brow positioning, perioral wrinkling, and total wrinkle score.
- the combined treatment group had a 400% increase in collagen in the biopsy results
- brow edema (1/8), erythema (1/8), and
- all were transient and mild in intensity
|Blue + infrared||Acne||Sadick||2009||A study to determine the effect of combination blue (415 nm) and near-infrared (830 nm) light-emitting diode (LED) therapy for moderate acne vulgaris||Open clinical trial||LED (adjustable planar arrays)|
Omnilux plus (Phototherapeutics Ltd, UK)
|415 + 830 nm||20 min ||alternating treatments twice weekly for 4 weeks ||2-5 cm|
- assessment based on lesion count
- average improvement of 44.2% in inflammatory lesions which is less than studies using blue/red light
- decrease of 48.8% in the noninflammatory lesions of 7 participants (greater than studies that used blue/red light)
|Skin rejuvenation||Lask et al.||2005||The utilization of nonthermal blue (405–425 nm) and near-infrared (850–890 nm) light in aesthetic dermatology and surgery—a multicenter study||Open clinical study|
metal halide lamp
Clear100XL, Curelight Ltd.
|405-425 nm + 850-890 nm |
|2 times/week for 4 weeks||20 cm|
|50 mW/cm2||not reported|
- very clear reduction of pore size and enhancement of skin vitality and radiance on 90% of patients
- results were stable for the duration of the follow-up (3 months)
- elimination of pores seems to be the most unique advantage of the light source
- photographs before, end of treatment and 1 and 3 months after
- no reported adverse effects
|Skin rejuvenation||Fournier et al.||2006||Use of Nonthermal Blue (405- to 420-nm) and Near-Infrared Light (850- to 900-nm) Dual-Wavelength System in Combination with Glycolic Acid Peels and Topical Vitamin C for Skin Photorejuvenation||Open clinical study|
metal halide lamp
|iClearXL, Curelight Ltd.||405-420 nm + 850-900 nm ||20 min ||twice per week for 4 weeks,||not reported|
|50 mW/cm2||60 J/cm2|
- patient satisfaction was high
- 80% of patients thought that they were improved on skin radiance
- 85% on pore size
- 50% on rhytids
- 75% on skin tone
- independent observer results were similar
- no reported adverse effects
|Blue + red||Acne||Kwon et al.||2013||The clinical and histological effect of home-use, combination blue-red LED phototherapy for mild to moderate acne vulgaris in Korean patients: a double-blind, randomized controlled trial||Double blind, sham device controlled RCT|
LED (adjustable planar arrays)
OCimple Light Therapy System MP 200Ò 200Ò (Ceragem Medisys Inc., Cheo- nan, Korea)
420 nm +
|2.5 m per wave length (5 min total)||twice daily for 4 weeks||not reported||n= 35|
6.1 mW/cm2 (blue) 8.1mW/cm2 (red)
0.91 J/cm2 blue
1.22 J/cm2 red
- clinical assessment of severity, lesion count, biopsies
- at 12 weeks, inflammatory and non-inflammatory lesions had decreased significantly, by 77% and 54% respectively
- sebum output reduction
- attenuated inflammatory cell infiltrations
- decreased size of the sebaceous glands
- IL-8, NFKB, IGF-1 receptor and SREBP-1c also decreased
- no severe adverse reactions
- 2 cases of mild dryness
- 1 case of mild erythema and desquamation that resolved within a day
|Acne||Lee et al.||2007||Blue and Red Light Combination LED Phototherapy for Acne Vulgaris in Patients with Skin Phototype IV||Open clinical trial ||LED (adjustable planar arrays)|
Omnilux blue, Photo Therapeutics Ltd., UK (5 articulated panels containing 260 LEDs each)
Omnilux revive, Photo Therapeutics Ltd., UK (4 articulated panels containing 420 LEDs each
|415 nm + 633 nm||20 min||twice per week for 4 weeks||3-5 cm from nose||n= 24 |
40 mW/cm2 (blue)
80 mW/cm2 (red)
48 J/cm2 (blue)
96 J/cm2 (red)
- 7 clinical assessments (before up to 8 weeks after final treatment)
- The final mean percentage improvements in noninflammatory and inflammatory lesions were 34.28% and 77.93 % respectively.
- melanin levels significantly decreased after combined treatment (increased with blue alone, decreased with red)
- brightened skin tone and improved skin texture were reported spontaneously by 14 patients.
- no side effects reported except a sense of mild warmth during the red light treatment
- two patients were dissatisfied with treatment because of erythema and hyperpigmentation at sites of previous acne lesions
|Acne||Goldberg & Russell||2006||Combination blue (415 nm) and red (633 nm) LED phototherapy in the treatment of mild to severe acne vulgaris||Open clinical trial |
LED (adjustable planar arrays)
(Phototherapeutics Ltd, UK)
|415 + 633 nm||20 min||1 blue and 1 red treatment each week for 4 weeks||1 cm from nose tip|
- a mean reduction in lesion count was observed at all follow-up points
- at 4 wks, 46%
- at 12 weeks 81%
- at 12 weeks, 9% reported total clearance
- reduction in papules, pustules, and nodules but comedone counts were minimally affected
- two subjects reported self-resolving facial erythema after treatments 2 and 3
|Acne||Papageorgiou et al.||2000||Phototherapy with blue (415 nm) and red (660 nm) light in the treatment of acne vulgaris||Observer blinded, placebo-controlled trial||fluorescent lamps 4x15 W||(type HF 885, Osram Sylvania, Belgium)||415 + 660 nm||15 min||daily for 12 weeks||25 cm|
- mean improvement of 76% in inflammatory lesions was achieved by the combined blue/red light;
- this was significantly superior to that achieved by blue light (at weeks 4 and 8 but not week 12), benzoyl peroxide (at weeks 8 and 12) or white light (at each assessment).
- The final mean improvement in comedones by using blue/red light was 58% again better than that achieved by the other active treatments used, although the differences did not reach significant levels.
- flareup of acne, dryness, rash
|Acne||Nestor et al. ||2016||Efficacy and Tolerability of a Combined 445nm and 630nm Over-the-counter Light Therapy Mask with and without Topical Salicylic Acid versus Topical Benzoyl Peroxide for the Treatment of Mild-to-moderate Acne Vulgaris||Randomized clinical trial|
|(illuMask® La Lumiere, LLC., Cleveland, Ohio)|
630 + 445 nm
|15 min||daily||direct contact||n= 105||not reported||not reported|
- light therapy mask-treated subjects showed a 24.4% improvement in inflammatory acne lesions versus 17.2% and 22.7% in benzoyl peroxide and light therapy mask with topical 1% salicylic acid with retinol, respectively,
- a 19.5% improvement in noninflammatory lesions verses 6.3 and 4.8 percent for benzoyl peroxide and light therapy mask with topical 1% salicylic acid with retinol, respectively.
- Subjects in the light therapy mask group also achieved a 19.0% improvement in the Investigator Global Acne Assessment versus 4.7% in benzoyl peroxide and 13.9% in light therapy mask with topical 1% salicylic acid with retinol.
- no reports of adverse events
|Acne||Alba et al.||2016||Clinical comparison of salicylic acid peel and LED Laser phototherapy to the treatment of acne vulgaris in teenagers||Longitudinal epidemiological|
Spectra G3® equipment (Tonederm, Caxias do Sul, Brazil)
blue 3 min
red one mimute
|weekly for 10 weeks||not reported||n= 22||not reported||6-8 J red laser|
- salicylic acid 10 % was effective in the treatment of acne, with a 90 % improvement in mild to moderate cases of acne
- Regarding phototherapy, the results showed a significant improvement in the acne treatment (Table 3), even in comparison to peeling with salicylic acid, notably on the difference in number of pustules
|Blue or green or violet ||Hyperpigmentation||Rosen et al.||1990||Immediate pigment darkening: visual and reflectance spectrophotometric analysis of action spectrum||Open human study|| Arc lamp: UVA and visible light ||5000-W xenon-mercury arc lamp equipped with a dichroic mirror to eliminate IR wavelengths||334, 365, 405, 435, or 549 nm wavelengths||up to 45 min||once||not reported|
334 nm, 4.1 mW/cm2; 365 nm 28.8 mW/cm2;
405 nm 11.3 mW/ cm2
435 nm 14.4 mW/cm2
549 nm 10.6 mW/cm2
|increasing doses at each wavelength,from 0.25 to 80 J/cm2|
- visual grading and reflectrance spectrophotometry
- The degree of IPD is first-order with respect to delivered dose and saturates after high doses.
- The maximum amount of IPD attained at saturation is greater for shorter wavelengths.
- Extrapolation of the reflectance data suggests the longest wavelength capable of eliciting IPD is about 470 nm
|Blue or red||Psoriasis|| Kleinpenning||2011||Efficacy of blue light vs. red light in the treatment of psoriasis: a double-blind, randomized comparative study||DB- Randomized Comparative Study|
- yes- funded by device company
LED-based blue light; Philips, Eindhoven, the Netherlands)
LED-based red light; Philips, Eindhoven, the Netherlands)
|420 nm and 630 nm||20 min||3x/week for 4 weeks ||not reported|
100 mW⁄ cm2
50 mW⁄ cm2
- psoriatic lesions showed statistically significant clinical improvement during the treatment period, which was reflected in a significant decrease in the clinical plaque severity (sum) score (30-40% for most variables)
- With respect to scaling and induration, no major differences between both light sources were seen.
- Improvement of erythema continued in blue light irradiated plaques throughout the whole study period, whereas after red light no significant improvement was seen after six illuminations.
- slight burning sensation during the irradiation with blue light
- Almost all areas treated with blue light showed surrounding hyperpigmentation (16 ⁄ 20, 80%)
- one patient demonstrated hyperpigmentation with red light
|Broad spectrum, blue + green||Acne||Sigurdsson et al.||1997||Phototherapy of Acne Vulgaris with Visible Light ||Open clinical trial |
UVA tanning lights with filters
philips HPA 400W
Philips HPM010 400W+ filter
Philips thallium arc lamp + filter
|not reported |
full spectrum: 5J/cm2 UVA, 16 J/cm2 violet, 9 J/cm2 green
0.5 J/cm2 UVA, 20 J/cm2 violet, 5 J/cm2 green
0.5 J/cm2 violet
50 J/cm2 green
- clinical assessment
- all light sources caused an improvement of acne: full spectrum 14%, green light 22% and violet light 30%
- no significant differences between the light sources, but violet trended towards being better
- had an effect mainly on inflammatory lesions
- the reduction in the number of inflammatory lesions was 49% for violet, 50% for full spectrum, and 24% for green light
|Sadick et al.||2010||Treatment of mild-to-moderate acne vulgaris using a combined light and heat energy device: Home-use clinical study||Randomized, placebo-controlled clinical trial|
|no!no! Skin device (Radiancy Inc.); light and heat device||450-2000 nm||not reported||twice a day for 4 days.||not reported|
|not reported||6 J/cm2 per treatment cycle (2 treatment cycles per 6-12 hours)|
- All lesions were photographed on a daily basis. Treatment results were assessed by two blinded evaluators, based on the macro photographs, using a 4-point visual analogue scale (VAS) and a photographic lesion reference scale (PLRS), as well as by the subjects.
- 92.24% of the lesions treated with an active device improved within a median time of 1 day versus 75.78% and a median time of 2 days for the placebo arm.
- At 24 hours the improvement rate was 76.72% for the active arm versus 15.63% for the placebo arm.
- 87.07% of the lesions treated with an active device improved within a median time of 2 days versus 64.8% and 3 days for the placebo.
- A total of 51.7% of the active arm lesions resolved within a median time of 4 days versus 36% (no median) for the placebo arm lesions.
- No device-related adverse events occurred throughout the study.
|Broadspectrum||Hyperpigmentation||Porges et al.||1988|
Quantification of visible light-induced melanogenesis in human skin.
|abstract only||abstract only||visible light||abstract only||abstract only||abstract only||abstract only||abstract only||abstract only||abstract only||abstract only|
- resulted in the induction of immediate pigment darkening (IPD), immediate erythema and a persistent (delayed) tanning reaction.
- Both IPD and immediate erythema faded over a 24-h period but, unlike erythema, the pigmentation did not totally disappear and the residual tanning response remained unchanged for the rest of the 10-day observation period.
- The threshold dose for IPD with visible light was between 40 and 80 J/cm2, while the threshold dose for "persistent" pigmentation was greater than or equal to 80 J/cm2
- VL at doses greater than 720 J cm−2 could induce pigment that lasted for up to 10 weeks
|Broadspectrum||Hyperpigmentation||Pathak||1962||Melanogenesis in human skin following exposure to long-wave ultraviolet and visible light*||Open human study||monochromatic light||German, Osram, 2,000 watt, air-cooled, xenon arc lamp||n/a||15—25 minutes|
|0.1 watt/cm2 at 300 mj (first order ultraviolet) and rises to 1.0 watt/cm2 at 450 m||45 J/cm2|
- peak IPD response occurred at wavelengths between 380 and 500 nm
- IPD developed in only 7 of the fair-skinned subjects, but a mild erythemal response could be detected visually in all 14 of these individuals immediately after irradiation
- Newly formed melanin could be seen in all 21 subjects 48—72 hours after exposure if a glass slide was pressed on the irradiated area to eliminate whatever crythemal component might be present. The irradiated areas of these subjects remained pigmented for more than 60 days.
|2011||Are there mechanistic differences between ultraviolet and visible radiation-induced skin pigmentation?||Open human study||visible light||sunlight with UV filter||n/a||24 min||n/a||n/a|
|n/a||6 J/cm2, 91 J/cm2 and 97 J/cm2 in the UV, visible and total sunlight region|
- IPD caused by the visible fraction of natural sunlight is as significant as that of UV. The IPD caused by exposure to total sunlight is only slightly higher than that of the IPD caused by either UV or visible fractions
- persistent pigment darkening (PPD) induced by the visible fraction of sunlight is significantly lower than that induced by the UV fraction.
- The dose responses of IPD induced by UV, visible light and total sunlight suggest that both UV and visible light interact with the same precursor
- UV is 25 times more efficient in inducing pigmentation per J/cm2 of irradiation compared to visible radiation.
|Broadspectrum||Hyperpigmentation||Kollias & Baqer||1984|
An experimental study of the changes in pigmentation in human skin in vivo with visible and near-infrared light.
|Open human study|
quartz envelope tungsten halogen lamp
Dolan-Jenner model 180 (Yoshida or GE, EJL 200W)
|390-1700 nm||20 min||one treatment||not reported|
0.3 W/cm2 total dose
- The “insoluble” photoproduct persists for periods of up to 8 weeks. The color change in the skin is immediate and there is no erythema associated with this color change.
- exposure times of greater than 15 min a bluish dark spot which had the exact dimension of the fiber optic bundle appeared
- For exposures of less than 30 min the spot disappears within 24 h.
- For exposures of 0.75 to 3.0 h we obtained a pigmented spot which persisted for as long as 8 weeks.
- The spot fades with time, maintaining its shape, without any changes in color (as perceived by eye)
|Broadspectrum||Hyperpigmentation||Mahmoud||2010||Impact of Long-Wavelength UVA and Visible Light on Melanocompetent Skin||Open human study||Halogen lamp|| Fiber-Lite Model 170-D (Dolan-Jenner Industries, Boxborough, MA) with a 150 W quartz halogen lamp||400-700 nm||not reported||not reported||not reported||n= 20||200 mW/cm2||8- 480 J/cm2|
- induction of immediate pigmentation at doses of 40 J/cm2 and higher in darker skin types
- pigmentation was sustained during the 2-week period of the study and did not fade
- no thermal or actinic damage was observed in the dermis
- redistribution of melanin to more superficial layers
- erythema could not be induced in type II skin, even at 480 J cm−2 , the highest fluence tested
- used eight times more visible radiation dose than UVA1 radiation in their study and found that the visible radiation-induced pigmentation is darker and more sustained than that induced by UVA1.
- They have also found that UV-induced pigmentation starts as grey and becomes brown later, while the visible radiation-induced pigmentation is brown from the start
Broadspectrum or red
|Actinic Keratoses||Szeimies et al.||2010||Photodynamic therapy with BF-200 ALA for the treatment of actinic keratosis: results of a prospective, randomized, double-blind, placebo-controlled phase III study||Phase III Clinical trial|
- yes - employees of the device company
Broadspectrum light source
Aktilite CL 128 LED (Photocure, ASA)
PhotoDyn 750 (Hydrosun Medizintechnik GmbH, Mulheim, Germany)
580-1400 nm + filter
|15 min||one or two treatments|
- photo documentation reviewed by an independent dermatologist
- PDT with BF-200 ALA was superior to placebo PDT with respect to patient complete clearance rate (per-protocol group: 64% vs. 11%; and lesion complete clearance rate (81% vs. 22%)
- Statistically significant differences in the patient and lesion complete clearance rates and adverse effect profiles were observed for the two light sources, Aktilite CL128 and PhotoDyn 750
- The patient and lesion complete clearance rates after illumination with the Aktilite CL128 were 96% and 99%, respectively vs 56% and 70%
- less adverse effects in placebo light only group
- pain 6% (photodyn 11.8%)
- burning 23.3% `(aktilite 31%; photodyn 17.6%)
|Broadspectrum or red||Actinic Keratosis||Dirschka et al.||2011||Photodynamic therapy with BF-200 ALA for the treatment of actinic keratosis: results of a multicentre, randomized, observer-blind phase III study in comparison with a registered methyl-5-aminolaevulinate cream and placebo||Phase 3 clinical trial||yes - consultants of sponsoring company |
Aktilite, Omnilux, 630 nm
PhotoDyn: 580 - 1400 nm
Waldmann PDT 1200L 600 to 750 nm
|Aktilite CL 128 (Photocure, Oslo, Norway), Omnilux PDTTM (Photo Therapeutics Inc., Montgomeryville, PA, U.S.A.), PhotoDyn 750 ⁄505 (Hydrosun Medizintechnik GmbH, Mu¨llheim, Germany) and Waldmann PDT 1200L (Waldmann Medizintechnik, Villingen-Schwenningen, Germany)||not reported||not reported|
1 or 2 ALA-PDT or placebo treatments
Aktilite, Omnilux: 37 J/cm2
PhotoDyn: 170 J/cm2
Waldmann PDT 1200L:
- The patient complete clearance rates 12 weeks after the last PDT were 78.2% for BF-200 ALA, 64.2% for MAL and 17.1% for placebo
- At the end of the study, 1359 of 1504 lesions and 1295 of 1557 lesions showed full remission after treatment with BF-200 ALA or MAL, respectively, while only 182 of 490 lesions were totally cleared after placebo treatment
- Complete clearance rates with placebo were higher with the broad-spectrum lamps (12.8% for narrow-spectrum lamps, 21.6% for broad-spectrum lamps)
- similar in treatment groups and lower in the placebo group (96.4%-98% of subjects treated, and 72.4% of placebo)
- Application site erythema (40.8%), burning (31.6%), and pain (25%)
- increased in patients treated with narrow-spectrum devices compared with those illuminated with broadspectrum light sources
|Broadspectrum or red||Skin rejuvenation||Nam et al.||2017||The Efficacy and Safety of 660 nm and 411 to 777 nm Light-Emitting Devices for Treating Wrinkles||DB- RCT|
|SKIN LABS; BS & Co., Ltd., Seoul, Korea|
|10 min||daily for 12 weeks||not reported|
1040-1070 lux white; 1630-1670 lux red
|5.17 J daily|
- the replica analysis showed a significant improvement in both groups, with a tendency to a greater reduction of periocular wrinkles in the red light group
- the digital photograph assessment by dermatologists didn't show any significant improvement
- the global improvement score was significantly higher in the red light group compared with the white light group
- 9 adverse events reported in the red light group and 3 adverse events in the white light group
- ocular symptoms such as glare, blurriness, floaters were transient
- one dropout due to floaters
|Broadspectrum or red||Skin rejuvenation||Wunsch & Matuschka||2014||A Controlled Trial to Determine the Efficacy of Red and Near-Infrared Light Treatment in Patient Satisfaction, Reduction of Fine Lines, Wrinkles, Skin Roughness, and Intradermal Collagen Density Increase||RCT|
- yes - funded by device company
medium and low-pressure lamps
ELT 2 - med pressure, partial body,
ELT 30 - med pressure, full body
C46 sun - low pressure, full body
CVT/RVT - low pressure, full body
treated twice a week
at least 30 treatments
7.1 (42.8) mW/cm2
10.4 (54.8) mW/cm2
5.9 (10.3) mW/cm2
13.3 (23.4) mW/cm2
8.5 (51.4) J/cm2
9.4 (49.3) J/cm2
8.9 (15.5) J/cm2
9.6 (16.8) J/cm2
- in the treated groups, skin complexion, feeling, collagen intensity score, roughness, wrinkle status improved significantly
- no significant differences were seen between the RLT and ELT groups
- all subjects continued to improve with 60 treatments but these differences displayed lower effect sizes than at 30 treatments
- the differences between the RLT and ELT wavelengths in clinical outcome and patient satisfaction were not significant
- measured by collagen ultrasonography
- no severe adverse events
- one subject noticed increased visibility of telangiectasia
- one subject experienced reddening of scar tissue from a 40 yr old knee injury; the affected scar healed completely within one week
|Infrared||Melasma||Barolet et al.||2018||Dual Effect of Photobiomodulation on Melasma: Downregulation of Hyperpigmentation and Enhanced Solar Resistance—A Pilot Study||Self-controlled Split face Clinical study||LED||Lumiphase IR; OpusMed, Canada||940 nm||5 min|
once per week for 8 weeks;
sequential pulsed mode, duty cycle of 50%
|90 mW/cm2||13.5 J/cm2|
- white light and UV pictures, melanin index scores and melasma area and severity index baseline and week 12
- the pulsed PBM treated side showed statistically significant results for pigment reduction
- followed up 12 months with 4 patients, 3/4 maintained the result
- partial improvement on untreated side indicating a possible systemic effect of PBM
|Skin rejuvenation||Stirling & Haslam||2007||A self-reported clinical trial investigates the efficacy of 1072 nm light as an anti-ageing agent||DB-RCT|
- yes - author is director of the device company
|LED||Restorelite, Virulite Distribution Ltd., UK||1072 nm||9 min daily ||daily for 8-10 weeks||not reported||n= 79||no info||no info|
- between 52-57% of volunteers were able to accurately identify an improvement in the fine lines and wrinkles of the treated areas of skin
- fewer volunteers (37-46%) observed an improvement in the bags under the treated eye or eyes with a strong statistical significance.
- no reported adverse effects
|Red||Actinic Keratoses||Szeimies et al.||2009||Topical Methyl Aminolevulinate Photodynamic Therapy Using Red Light-Emitting Diode Light for Multiple Actinic Keratoses: A Randomized Study||Double blind, placebo controlled, RCT|
- yes - funded by device company
|Aktilite CL 128 LED (Photocure, ASA)||630 nm||9 min||twice, one week apart||5-8 cm|
|74 mW/cm2||37 J/cm2|
- MAL-PDT was superior to placebo with respect to lesion complete response rate (83.3% vs 28.7%)
- response rates were similar in all thicknesses, which differs from similar studies that used broadband light
- MAL-PDT was superior to placebo PDT with respect to patient complete response rates (68.4% vs 6.9%)
- fewer new lesions developed with MAL-PDT (18% vs 34%)
- 85% of MAL-PDT and 60% of placebo subjects reported adverse events
- pain, erythema, burning
|Actinic Keratosis||Reinhold et al.||2016||A randomized, double-blind, phase III, multicentre study to evaluate the safety and efficacy of BF-200 ALA (Ameluz) vs. placebo in the field-directed treatment of mild-to-moderate actinic keratosis with photodynamic therapy (PDT) when using the BF-RhodoLED lamp||Phase III Clinical trial||yes - employees of the device company||LED lamp||BF-RhodoLED ||635 nm||10 min||1-2 treatments||5-8 cm|
|not reported||37 J/cm2|
- lesion clearance assessed by visual inspection and palpation
- biopsy at the end-of-study visit
- complete clearance after 12 weeks in PDT 91% vs. 22% LED only
- overall 94.3% ALA and 32.9% LED lesions were cleared
- 91% ALA satisfied, 45% LED satisfied
- one new lesion in the LED group
- Grade 1 lesions had a higher complete response rate 99.1 and 49.2
- 69% of LED reported side effects (could be due to endogenous activation of ALA)
- pain was most common 5.5/11 vs 0.9/11
- pain, erythema, pruritus, scab, exfoliation, edema, vesicles (mild-moderate intensity)
|Hyperpigmentation||Barolet & Boucher||2008||LED Photoprevention: Reduced MED Response Following Multiple LED Exposures||Open human study||LED||LED Photoprophylaxis Lumi-Phase-R (Opusmed Inc. Canada)||660 nm||160 s||1-3 weeks||not reported|
sequential pulsing mode
|60 mW/cm2||5 J/cm2|
- significant LED treatment reduction in UV-B induced erythema reaction was observed in at least one occasion in 85% of subjects, including patients suffering from PLE.
- there was evidence of a dose-related pattern in results
- a sun protection factor SPF-15-like effect and a reduction in post-inflammatory hyperpigmentation were observed on the LED pre-treated side
|Safety of Red Light||Tijoe et al.||2003||High-dose long-wave visible light induces perinuclear vacuolization in vivo but does not result in early photoageing and apoptosis||Open clinical trial|
Waldmann 1200 L PDT (halogen) lamp
| (Herbert Waldmann GmbH & Co., Villingen-Schwenningen, Germany)||560-780 nm||not reported||5 consecutive days||not reported|
|not reported||130 J/cm2 per day; cumulative dose 650 J./cm2|
- In each volunteer, six biopsies were taken before and 24 h after irradiation on days 1, 2, 3 and 5 and on day 8 and 12.
- Frozen and paraffin sections were investigated by measuring parameters for photodamage (apoptosis, p53, phosphorylated c-Jun), skin aging (phosphorylated c-Jun, MMP-1, elastin content) melanogenesis (Melan A).
- Although no sunburn cells were seen, a significant increase in perinuclear vacuolization was noted from day 5 till 7 days after the last irradiation.
- There was no expression of phosphorylated c-Jun, whereas the expression of p53, Melan A, MMP-1, and elastin content did not change.
- treatment was well tolerated
- one subject noted a slight heat-induced erythema
|Skin rejuvenation||Sanclemente et al.||2010||A prospective split-face double-blind randomized placebo-controlled trial to assess the efficacy of methyl aminolevulinate + red-light in patients with facial photodamage||DB-RCT |
- yes - authors are speakers for the company
|LED||Aktilite; Galderma||630 nm||8 min||two sessions at an interval of 15 days||not reported|| n= 48||not reported||at 37 J ⁄ cm|
- Primary outcome was assessed by a trained blinded dermatologist
- LED only group showed no difference in global photoaging score
- 2/48 showed an improvement in specific photoaging
- 1/48 showed improvement in each of hyperpigmentation, roughness, complexion quality, telangiectasia
- no improvement in coarse wrinkles
- erythema (6), edema (4), desquamation (2), pigmentation (3), vesiculation (1)
|Ji et al.||2014||Comparison of 5-aminolevulinic acid photodynamic therapy and red light for treatment of photoaging||Open clinical trial||LED||Philips ||630 nm||30 min||3 times per week for 4 weeks||not reported|
|50 mW/cm2||not reported|
- dermoscopy, corneometer, TEWLmeter, portable skin photospectrometer, biopsy
- subjects reported a noticeable improvement after red light treatment (12x)
- marked improvement in skin appearance and elimination of photodamaging (texture and hyperpigmentation) signs in both groups
- SC hydration increased 12.5%
- TEWL decreased 30%
- typical signs of solar elastosis were improved in both groups
- epidermis became thicker
- collagen fibers increased
- increased content of elastic fibers
|Skin rejuvenation||Zhang et al.||2014||Evaluation of 5-aminolevulinic acid-mediated photorejuvenation of neck skin||DB-RCT|| LED ||Philips, Netherlands||630 nm||10 min||2 treatments at a 4-week interval||not reported|
| 50 mW/cm2||60 Jcm2|
- No significant change in photoaging was noticed in red-light group.
- No erythema, edema, blistering, crusting, burning or dyspigmentation occurred in the light only group
|Skin rejuvenation||Shaoul & Mulholland||2011||Evaluation of the Safety and Efficacy of a Novel Home-Use Device with Diode Arrays and Contact Heating for Facial Skin Rejuvenation||Open clinical study||LED||Silk’n Reju/FaceFX home-use device (Home Skinovations, Yokneam, Israel||645 nm||5-7 min/facial zone (7 zones)||8 bi-weekly treatments for 4 weeks||not reported|
|not reported||not reported|
- Facial skin improvement of wrinkling and skin texture were apparent immediately and scored clinically after 3 months as excellent and considerable by >90% of patients.
- Pigmentation improvement was less apparent.
- Overall facial skin improvement was noted by 77% of patients
- Slight erythema and edema was noted in most patients within 5 minutes and lasted for about 30 minutes post-treatment
|Skin rejuvenation||Sommer & Zhu.||2007||Green Tea and Red Light— A Powerful Duo in Skin Rejuvenation||Open clinical study||LED||WARP 10, Quantum Devices, Inc., Barneveld, WI||670 nm||not reported||1 month of daily application of green tea and a dermal dose of 4 J/cm2 of red light ||not reported|
|72.8 mW/cm2||4 J/cm2|
- Rejuvenated skin, reduced wrinkle levels, and juvenile complexion, previously realized in 10 months of light treatment alone were realized in 1 month
|Skin rejuvenation||Barolet et al.||2009||Regulation of Skin Collagen Metabolism In Vitro Using a Pulsed 660 nm LED Light Source||Split-face single-blinded study|
- yes - author has IP over pulsing code
|LED||Lumi-Phase-R (Opusmed Inc. Canada)||660 nm||160 s||3x/week for 4 weeks||2.5 cm|
|50 mW/cm2||4 J/cm2|
- profilometry quantification revealed that more than 90% of individuals showed a reduction in rhytid depth and surface roughness
- 87% experienced a reduction in the Fitzpatrick wrinkling severity score after 12 LED treatments
- LED therapy reversed collagen downregulation and MMP-1 upregulation.
- No adverse events or downtime were reported.
|Skin rejuvenation||Barolet et al.||2005|
In vivo human dermal collagen
production following LED-based therapy: the importance of treatment parameters
|Open clinical study||LED||LumiPhase-R (Opusmed Inc. Canada)||660 nm||not reported||12 treatments over 4 weeks||not reported|
Left Forearm: 0.1 J/cm2
- Twelve treatment sessions at high fluence (5 J/cm2) and high irradiance (60
mW/cm2) induced an increase of 50% in type III pro-collagen production rate compared to non-treated control site with sequentially pulsed LED therapy
- the increase was only 29% with CW mode.
- for the same number of treatments, the same pattern occurred at low fluence (0.1 J/cm2) and low irradiance (5 mW/cm2) inducing an increase of 76% in type III pro-collagen production rate compared to non-treated control site with the sequential pulsing mode, whereas the increase was only 38% (p= 0.05) with CW mode
|Skin rejuvenation||Bhat et al.||2005||A single-blinded randomized controlled study to determine the efficacy of Omnilux Revive facial treatment in skin rejuvenation||SB-RCT|
- yes - funded by device company
|LED||Omnilux Revive (PhotoTherapeutics Ltd., Manchester, UK)||633 nm||20 min||3 times for 3 weeks = 9 treatments||not reported|
|80 mW/cm2||96 J/cm2|
- Regular assessments were carried out, focusing on parameters of subject satisfaction, photographic assessments, skin elasticity (Cutometer) and skin hydration (Corneometer CM825).
- Ninety-one percent of the volunteers reported visible changes to their skin.
- Blinded photographic evaluation reported a clinical response in 59% of the subjects.
- Objective analysis failed to show statistically significant changes in skin hydration or elasticity
- no adverse effects or downtime
|Skin rejuvenation||Takezaki et al.||2005||Ultrastructural Observations Of Human Skin Following Irradiation With Visible Red Light-Emitting Diodes (LEDs): A Preliminary In Vivo Report||Open human study||LED||Omnilux revive||633 nm||15 min||once per week for 8 weeks||1.5 cm||n= 6||105 mW/cm2||96 J/cm2|
- increased number of fibroblasts
- mild inflammatory infiltrate
- ultrastructure showed no damage related abnormalities
- enhanced metabolism
|Red + infrared||Psoriasis (chronic)||Ablon ||2010||Combination 830-nm and 633-nm Light-Emitting Diode Phototherapy Shows Promise in the Treatment of Recalcitrant Psoriasis: Preliminary Findings||Open clinical trial|
|Omnilux from Photo Therapeutics (Carlsbad, CA)|
Red light (633 nm)
|20-min||two sessions per week over 4 or 5 weeks||not reported|
830 nm, 60 J/cm2
633 nm, 126 J/cm2
- Clearance rates at the end of the follow-up period ranged from 60% to 100%. Satisfaction was universally very high
|Skin rejuvenation||Goldberg et al.||2006||Combined 633-nm and 830-nm LED treatment of photoaging skin||Open clinical study|
|Omnilux Revive and Omnilux Plus (Photo Therapeutics Ltd, Altringham, Manchester, UK) ||Combined 830 and 633 nm|| 20 minutes ||9 light therapy treatments (6 infrared and 3 red) over a 5-week period||not reported|
- In 51.6% of the study population, there was a 25% to 50% improvement in photoaging scores at the 12-week follow-up and a 12.9% improvement in the 50% to 75% bracket
- Softening of periorbital wrinkles was reported by 83.9% of subjects at 9 weeks and 80.6% at 12 weeks
- The majority of subjects reported improvements in softness, smoothness, and firmness at all time points.
- Electron microscopic analysis consistently showed evidence of increased thicker new collagen fibrils after treatment
- Mild erythema was recorded in one subject (3.2%) at day 8 and by 7 subjects (23%) at follow-up on day 15.
|Skin rejuvenation||Baez & Reilly||2007||The use of light-emitting diode therapy in the treatment of photoaged skin||Open clinical study|
Omnilux Revive™ exposure)
Omnilux Plus™ (Phototherapeutics Ltd, Altringham, Manchester, UK)
red light 633 ± 3 nm
830 ± 5 nm
| 20 minutes ||9 light therapy treatments (6 infrared and 3 red) over a 5-week period||not reported|
- The majority of subjects displayed moderate (50%) or slight (25%) response to treatment.
- Treatment of the periorbital region was reported more effective than the nasolabial.
- Nine percent of the subjects achieved 75%, and 27% of subjects achieved 50% improvement in periorbital photodamage score at the 12-week follow-up.
- Regarding the nasolabial fold, 9% of subjects displayed 50% response, and the remainder were assessed as having “slight” 25% response at the 12-week follow-up
|Skin rejuvenation||Sadick||2008||A study to determine the efficacy of a novel handheld light-emitting diode device in the treatment of photoaged skin||Open clinical study|
active area 60x50 mm
|Omnilux New-U, Photo Therapeutics Inc., USA||830 + 633 nm|
20 min infrared
30 min red
|alternating twice weekly for a period of 4 weeks (8 treatments)||not reported|
- Clinical grading of wrinkles and photodamage according to Glogau scale
- Subject's own assessment
- 73% reported the outcome as either good or excellent
- at the end of the 12 wk follow-up, subjects reported improved skin tone (84%), improved smoothness and clarity (>70%), firmness (68%) and elasticity (47%)
- 84% rated the product very easy or extremely easy to use
- no adverse events
- mild side effect of facial erythema after the first treatment in 3 subjects
|Skin rejuvenation||Russell et al.||2005||A study to determine the efficacy of combination LED light therapy (633 nm and 830 nm) in facial skin rejuvenation||Open clinical trial||LED||(Omnilux ReviveTM and Omnilux PlusTM, Phototherapeutics Ltd, Altringham, Manchester, UK.||633 + 830 nm|
|nine light therapy treatments over a five-week period (IR 6 times + red 3 times)||1 cm|
- mean density of furrows was significantly reduced at 9-week followup
- Photoaging assessment scores showed significant improvement at all follow-up points: 51.6% of the study population displayed a 25%– 50% improvement in photoaging scores at 12-week follow-up and 12.9% displayed improvement in the 50%–75% bracket.
- Softening of periorbital wrinkles was reported by 83.9% of subjects at 9 weeks and 80.6% at 12 weeks
- At 9 weeks, 66.8% of subjects personally reported the effect of treatment to be ‘‘excellent’’ or ‘‘good’’ in terms of periorbital wrinkle softening;
- 58% reported this effect at 12-week follow up
|Skin rejuvenation||Migliardi et al.||2009||Non-invasive Peri-orbital Rejuvenation: Radiofrequency Dual Radiowave Energy Source (RF) and Light Emission Diode System (LED)||Open clinical study||LED||Light active, Bi-medica||633 nm + 880 nm|
35 s pulsed red
35 s pulsed infrared
|8 treatments, one every 5 days||a few cm||n=30 ||not reported||not reported|
- LED was effective on improvement of skin texture and rhytides reduction while slightly effective on the firmness
- RF was effective on skin texture and firmness while slightly effective on rhytides reduction
- together they were effective on all parameters
|Red or infrared or combined||Skin rejuvenation||Lee et al.||2007||A prospective, randomized, placebo-controlled, double-blinded, and split-face clinical study on LED phototherapy for skin rejuvenation: Clinical, profilometric, histologic, ultrastructural, and biochemical evaluations and comparison of three different treatment settings||DB-RCT|
- yes - device company funded
infrared: Omnilux plusTM, Photo Therapeutics Ltd., Fazeley, UK
red: Omnilux reviveTM, Photo Therapeutics Ltd
|830 nm, 633 nm, a combination of 830+633 nm||20 min ||twice a week for four weeks||1-10 cm |
55 mW/ cm2 infrared
105 mW/cm2 for the red light
66 J/cm2 infrared
126 J/cm2 red
- Serial photography, profilometry, and objective measurements of the skin elasticity and melanin were performed during the treatment period with a three-month follow-up period.
- Skin specimens were evaluated for the histologic and ultrastructural changes, alteration in the status of matrix metalloproteinases (MMPs) and their tissue inhibitors (TIMPs), and the changes in the mRNA levels of IL-1ß, TNF-a, ICAM-1, IL-6 and connexin 43 (Cx43),
- significant reductions of wrinkles (maximum: 36%) and increases of skin elasticity (maximum: 19%) compared to baseline on the treated face in the three treatment groups.
- Histologically, a marked increase in the amount of collagen and elastic fibers in all treatment groups was observed.
- Ultrastructural examination demonstrated highly activated fibroblasts, surrounded by abundant elastic and collagen fibers.
- Immunohistochemistry showed an increase in TIMP-1 and 2. RT-PCR results showed the mRNA levels of IL-1ß, TNF-a, ICAM-1, and Cx43 increased after LED phototherapy whereas that of IL-6 decreased.
|Yellow||Skin rejuvenation||Weiss et al.||2006||Clinical Experience with Light-Emitting Diode (LED) Photomodulation||Retrospective analysis|
- yes - funded by the device company
|LED||GentleWaves light-emitting diode (LED) system (LightBioScience, Virginia Beach, VA, USA||590 nm|
|eight treatments over a 4-week period||2cm|
|not reported||0.1 J/cm2|
- softening of skin texture and a reduction in roughness and fine lines that ranged from a significant reduction to sometimes subtle changes.
- Improvement was noted by 90% of patients, with only 10% reporting themselves as nonresponders.
- Similar to previous reports, 60% of patients were noted in the treatment record by the physician to demonstrate global improvement in a combination of facial texture, fine lines, background erythema, and pigmentation.
|Boulos et al.||2009||In the Eye of the Beholder: Skin Rejuvenation Using a Light-Emitting Diode Photomodulation Device||Open clinical trial|
|GentleWaves light-emitting diode (LED) system (Light BioScience, LLC, Virginia Beach, VA||590 nm||40 s||once a week for 8 weeks||not reported||n= 36||not reported||0.1 J/cm2|
- photographs, clinical assessment, and subjective questionnaire, blinded observers asked to pick the post-treatment photo
- for every facial characteristic studied and for both timepoint comparisons' patients reported highly statistically significant improvements
- neither physicians assessment not the independent observer's evaluation indicated any improvement
- data suggest that the LED photomodulation treatment from the device tested is a placebo
|Skin rejuvenation||Weiss et al.||2005||Clinical Trial of a Novel Non-Thermal LED Array for Reversal of Photoaging: Clinical, Histologic, and Surface Profilometric Results||Random cohort study|
- yes - financial interests by the authors
|LED||GentleWaves light-emitting diode (LED) system unit, LightBioScience, LLC, Virginia Beach, VA ||590 nm||not reported||8 treatments over 4 weeks||2 cm|
|not reported||0.1 J/cm2|
- digital photography, skin surface topography, biopsies
- digital imaging showed a reduction of signs of photoaging in 90% of subjects with smoother texture, reduction of peri-orbital rhytids, and a reduction of erythema and pigmentation
- optical profilometry showed a 10 % improvement
- histology showed markedly increased dermal collagen in 100% of biopsies
- 28% increase in collagen density, with an average reduction of 4% of MMP