Skin Rejuvenation by Low-Level Light Therapy - Table 2: Clinical Trials

• yes - consultant of the device company

LED 
(handheld)

n=30

• 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

• none reported

• none declared

twice weekly for 4 weeks

n=30

• 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 

• none declared

twice per week 

4-8 wks

n=45

• 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.

• no adverse effects 

• none declared

400 W metal halide lamp with UV-cut filters; 20x20 cm

n= 30

• 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

• none declared

n= 20

• 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%)

• none declared

Waldmann 450L photodynamic therapy lamp

n= 8

• 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

• none declared

n= 17

• 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

• yes - funded by device company

LED

High-intensity n=24

Low-intensity n=23

200 mW/cm2

100 mW/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 

Psoriasis

(mild to moderate)

• yes - funded by device company

LED

453 nm

420 nm

• 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

• yes - authors are consultants or employee of device company

KLOX LED light

n= 8

, 

• 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

• none declared

Omnilux blue 

Omnilux plus (Phototherapeutics Ltd, UK)

n=11

40 mW/cm2

55 mW/cm2

48 J/cm2

66 J/cm2

• 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)

• no adverse events

• none declared

metal halide lamp

30x30cm

30x60 cm

iClearXL 

Clear100XL, Curelight Ltd. 

15 min/side

n= 30 

• 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

• none declared

metal halide lamp

30x30 cm

n=20

• 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

• none declared

LED (adjustable planar arrays)

OCimple Light Therapy System MP 200Ò (Ceragem Medisys Inc., Cheo- nan, Korea)

420 nm +

660 nm

6.1 mW/cm2 (blue) 8.1mW/cm2 (red) 

single treatment 

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

• none declared

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

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

• none declared

LED (adjustable planar arrays)

Omnilux blue

Omnilux revive

(Phototherapeutics Ltd, UK)

n=22

40 mW/cm2

80 mW/cm2

48 J/cm2

96 J/cm2

• 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

• none declared

n=107

4.23 mW/cm2; 

2.67 mW/cm2

total dose:

320 J/cm2

202 J/cm2

• 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

• funded by device company

LED 

(mask)

630 + 445 nm

simultaneously

•  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

• none declared

LED

Laser

Spectra G3® equipment (Tonederm, Caxias do Sul, Brazil)

470 nm

660 nm

blue 3 min

red one mimute

• 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

• no adverse events

• none declared

n= 7

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

• 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

• yes- funded by device company

LED

LED-based blue light; Philips, Eindhoven, the Netherlands)

LED-based red light; Philips, Eindhoven, the Netherlands) 

n= 20

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

• none declared

UVA tanning lights with filters

philips HPA 400W 

Philips HPM010 400W+ filter

Philips thallium arc lamp + filter 

full spectrum

420 nm

540 nm

3x/week

20 sessions

n= 30

full spectrum: 5J/cm2 UVA, 16 J/cm2 violet, 9 J/cm2 green

violet: 

0.5 J/cm2 UVA, 20 J/cm2 violet, 5 J/cm2 green

green:

no UVA

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

Acne

• none declared

Broad-spectrum flash

n= 63

•  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.

Quantification of visible light-induced melanogenesis in human skin.

• 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

• none declared

n=21

• 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.

Ramasubramaniam

et al.

• none declared

n=18

• 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. 

An experimental study of the changes in pigmentation in human skin in vivo with visible and near-infrared light.

• none declared

quartz envelope tungsten halogen lamp

Dolan-Jenner model 180 (Yoshida or GE, EJL 200W)

n= 8

0.3 W/cm2 total dose

270 W/cm2

• 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)

• none reported 

• none declared

•  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

• none reported

Broadspectrum or red

• yes - employees of the device company

LED panel

8x18cm

Broadspectrum light source

Aktilite CL 128 LED (Photocure, ASA)

PhotoDyn 750 (Hydrosun Medizintechnik GmbH, Mulheim, Germany)

630 nm 

580-1400 nm + filter

5-8 cm

27 cm 

n= 122

50-70 mW/cm2

196 mW/cm2

37 J/cm2

170 J/cm2

• 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%)

Aktilite, Omnilux, 630 nm 

PhotoDyn: 580 - 1400 nm 

Waldmann PDT 1200L 600 to 750 nm

1 or 2 ALA-PDT or placebo treatments

n= 571

Aktilite, Omnilux: 37 J/cm2

PhotoDyn: 170 J/cm2

Waldmann PDT 1200L:

100 J/cm2

• 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

• none declared

LED

Red light
LED
660 nm

White light
LED
411-777 nm

n=52 

24 White

28 Red 

1040-1070 lux white; 1630-1670 lux red 

7.5 mW/cm2

• 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

• 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

611–650

570–850 nm 

20 min

15 min

25 min

12 min

treated twice a week

at least 30 treatments

n= 128

57 RLT

48 ELT

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

• none declared

once per week for 8 weeks;

sequential pulsed mode, duty cycle of 50%

n=7

• 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

• none reported

• yes - author is director of the device company

• 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

• yes - funded by device company

LED panel

8x18cm

n= 115

• 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

n=87

• 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)

• none declared

n=15

sequential pulsing mode 

• 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

• none reported

• none declared

Waldmann 1200 L PDT (halogen) lamp

n=14

• 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 

• yes - authors are speakers for the company

• 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)

Skin rejuvenation

• none reported

n= 14 

• 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

• not reported

• none declared

n= 24

• 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

• none declared

n= 40

• 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 

• none declared

n= 1

• Rejuvenated skin, reduced wrinkle levels, and juvenile complexion, previously realized in 10 months of light treatment alone were realized in 1 month

• none reported

• yes - author has IP over pulsing code

n=40 

• 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.

In vivo human dermal collagen 
production following LED-based therapy: the importance of treatment parameters 

• none declared

n= 10

60 mW/cm2

5 mW/cm2

Left Forearm: 0.1 J/cm2

Right Forearm:
5 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

• none reported

• yes - funded by device company

n= 23

• 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

• none declared

• increased number of fibroblasts
• mild inflammatory infiltrate
• ultrastructure showed no damage related abnormalities
• enhanced metabolism

• no adverse effects

• none declared

LED

Red light (633 nm)

Near-IR
830 nm

n=9

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

• no adverse effects

• none declared

LED

(planar arrays)

n= 36

55 mW/cm2

105 mW/cm2

66 J/cm2

126 J/cm2

• 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. 

• none declared

LED

(planar arrays)

Omnilux Revive™ exposure)

Omnilux Plus™ (Phototherapeutics Ltd, Altringham, Manchester, UK)

red light 633 ± 3 nm

830 ± 5 nm

n= 13

105 mW/cm2

55 mW/cm2

126 J/cm2

66 J/cm2

• 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

• none reported

• none declared

LED

(handheld)

active area 60x50 mm

20 min infrared

30 min red

n=19

55 mW/cm2

70 mW/cm2

66 J/cm2

126 J/cm2

• 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

• none declared

20 min 

n= 31 

55 mW/cm2

105 mW/cm2

66 J/cm2

126 J/cm2

• 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

• none reported

• none declared

35 s pulsed red

35 s pulsed infrared

• 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

• yes - device company funded

infrared: Omnilux plusTM, Photo Therapeutics Ltd., Fazeley, UK

red: Omnilux reviveTM, Photo Therapeutics Ltd

n=76

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. 

• no adverse effects 

• yes - funded by the device company

60 s

100 pulses

n= 300

• 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.

• none reported

Skin rejuvenation

• none declared

LED

• 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

• none reported

• yes - financial interests by the authors

n=90

• 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

• no side effects or pain