Efficacy of Red Light in the Treatment of Pigmentary Disorders

Study Overview
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Brief Summary
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Pigmentary disorders such as melasma, lichen planus pigmentosus and vitiligo can significantly affect patients' quality of life. Treatment responses are usually slow and typically have limited efficacy. In recent years, low level laser therapy has been an emerging treatment modality for androgenetic alopecia, acne, wound healing and photorejuvenation. This is a prospective, double-blind, split-body, randomized controlled trial assessing the efficacy of low level laser therapy with red light for pigmentary disorders such as, melasma, lichen planus pigmentosus and vitiligo.

Detailed Description
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This will be a participant and evaluator blinded trial with random allocation of one side of the face or affected area to treatment and the contralateral side as control. Random allocation of the treatment side will be performed using randomization software. Participants will be treated twice a week for 12 weeks with low irradiation 650 nm +/- 5 nm red light and followed up 4 weeks after completion of treatment. A trained blinded evaluator will assess clinical outcomes on week 4, week 8, week 12 and at follow up at week 16, using validated scores.

Official Title
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A Prospective, Double-blind, Split-body, Randomized Controlled Trial to Assess the Efficacy of Low Level Laser Therapy for Pigmentary Disorders

Conditions
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Melasma, Lichen Planus Pigmentosus, Vitiligo

Intervention / Treatment
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* Device: Red light


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be 18 years or older. Participants should be competent to give fully informed consent by themselves Should have received a diagnosis of either melasma, lichen planus pigmentosus or vitiligo either clinically or pathologically and have bilateral facial hyperpigmentation/depigmentation or bilateral similar sized depigmented/hyperpigmented patches or a single patch larger than 25 cm2. Participants must stop receiving topical treatments or phototherapy 4 weeks prior to commencing the study Exclusion Criteria: Known photosensitivity disorder Unable to attend follow up appointments or twice weekly treatments

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low level red light/laser<br>Patients will be treated twice a week for 12 weeks with low irradiation 650 nm +/- 5 nm red light on one randomly allocated side of the face or body | Device: Red light<br>* Low irradiation 650 nm +/- 5 nm red light<br>* Other names: Low level laser therapy;|
| No Intervention: Control side<br>An affected area on the contralateral side of the face or body or within a single patch will not be treated | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Modified-MASI (Melasma Area and Severity Index) compared to baseline for melasma and lichen planus pigmentosus | A trained blinded evaluator will assess clinical outcomes on week 4, week 8, week 12 and at follow up at week 16, using validated scores to assess change from baseline | Week 0, week 4, week 8, week 12 and at follow up at week 16 | 
| Change in DPASI (Dermal Pigmentation Area and Severity score) compared to baseline for lichen planus pigmentosus | A trained blinded evaluator will assess clinical outcomes on week 4, week 8, week 12 and at follow up at week 16, using validated scores to assess change from baseline | Week 0, week 4, week 8, week 12 and at follow up at week 16 | 
| Change in VASI (Vitiligo Area Scoring Index) compared to baseline for vitiligo | A trained blinded evaluator will assess clinical outcomes on week 4, week 8, week 12 and at follow up at week 16, using validated scores to assess change from baseline | Week 0, week 4, week 8, week 12 and at follow up at week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colorimeter measurements | Change in average L*a*b color system will be measured for background skin and the area of hyperpigmentation or depigmentation from baseline. | Week 0, week 4, week 8, week 12 and at follow up at week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melasma, Lichen planus pigmentosus, Vitiligo, Low level laser therapy, Photobiomodulation, Red light, Pigmentation disorders