Efficacy of Red Light in the Treatment of Pigmentary Disorders

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

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.

Study Overview

• Status: Unknown
• Conditions: Vitiligo; Melasma; Lichen Planus Pigmentosus
• Intervention / Treatment: Device: Red light

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.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sunil Kalia, MD MHSc FRCPC; Phone Number: +1 604-875-4747; Email: sunil.kalia@ubc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E8
      • Recruiting
      • The Skin Care Centre, Vancouver General Hospital
      • Contact: Sunil Kalia, MD MHSc FRCPC; Phone Number: +1 604-875-4747; Email: sunil.kalia@ubc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Device: Red light; Low irradiation 650 nm +/- 5 nm red light; Other Names: Low level laser therapy
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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Global Assessment	Physician global assessment at the end of treatment at follow up will be assessed to identify change in pigmentation compared to baseline photographs.	Week 16
Patient global assessment		Week 16

Collaborators and Investigators

• Sponsor: University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 16, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Melasma; Photobiomodulation; Vitiligo; Low level laser therapy; Red light; Lichen planus pigmentosus; Pigmentation disorders
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Hyperpigmentation; Pigmentation Disorders; Hypopigmentation; Lichenoid Eruptions; Melanosis; Vitiligo; Lichen Planus
• Other Study ID Numbers: H20-00293

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes