Efficacy of Red Light in the Treatment of Pigmentary Disorders

Vitiligo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04308421
• Other study ID #: H20-00293
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: September 2020

Study information

• Verified date: March 2020
• Source: University of British Columbia
• Contact: Sunil Kalia, MD MHSc FRCPC
• Phone: +1 604-875-4747
• Email: sunil.kalia[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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:

• Known photosensitivity disorder

• Unable to attend follow up appointments or twice weekly treatments

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus Pigmentosus
• Melanosis
• Melasma
• Vitiligo

Intervention

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

Locations

Country	Name	City	State
Canada	The Skin Care Centre, Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Patient global assessment		Week 16
Primary	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
Primary	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
Primary	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	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