Efficacy of Red Light in the Treatment of Pigmentary Disorders

Not Applicable

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Low level red light/laser	Red light	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

Primary Outcome Measures

Name	Time	Method
Change in Modified-MASI (Melasma Area and Severity Index) compared to baseline for melasma and lichen planus pigmentosus	Week 0, week 4, week 8, week 12 and at follow up at week 16	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
Change in DPASI (Dermal Pigmentation Area and Severity score) compared to baseline for lichen planus pigmentosus	Week 0, week 4, week 8, week 12 and at follow up at week 16	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
Change in VASI (Vitiligo Area Scoring Index) compared to baseline for vitiligo	Week 0, week 4, week 8, week 12 and at follow up at week 16	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

Secondary Outcome Measures

Name	Time	Method
Colorimeter measurements	Week 0, week 4, week 8, week 12 and at follow up at week 16	Change in average L\a\b color system will be measured for background skin and the area of hyperpigmentation or depigmentation from baseline.

Locations (1): The Skin Care Centre, Vancouver General Hospital
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Vancouver, British Columbia, Canada

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