Efficacy of Red Light in the Treatment of Pigmentary Disorders

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: September 2020

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.

Interventions

  • Device: Red light
    • Low irradiation 650 nm +/- 5 nm red light

Arms, Groups and Cohorts

  • Experimental: Low level red light/laser
    • 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
  • No Intervention: Control side
    • An affected area on the contralateral side of the face or body or within a single patch will not be treated

Clinical Trial Outcome Measures

Primary Measures

  • Change in Modified-MASI (Melasma Area and Severity Index) compared to baseline for melasma and lichen planus pigmentosus
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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 Measures

  • Colorimeter measurements
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of British Columbia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sunil Kalia, Principal Investigator – University of British Columbia
  • Overall Contact(s)
    • Sunil Kalia, MD MHSc FRCPC, +1 604-875-4747, sunil.kalia@ubc.ca

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.