Clinical trial NCT04308421: Efficacy of Red Light in the Treatment of Pigmentary Disorders
Official title: A Prospective, Double-blind, Split-body, Randomized Controlled Trial to Assess the Efficacy of Low Level Laser Therapy for Pigmentary Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Melasma
Lichen Planus Pigmentosus
Vitiligo
Keywords: Melasma
Lichen planus pigmentosus
Vitiligo
Low level laser therapy
Photobiomodulation
Red light
Pigmentation disorders
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Modified-MASI (Melasma Area and Severity Index) compared to baseline for melasma and lichen planus pigmentosus
timeFrame: Week 0, week 4, week 8, week 12 and at follow up at week 16
measure: Change in DPASI (Dermal Pigmentation Area and Severity score) compared to baseline for lichen planus pigmentosus
timeFrame: Week 0, week 4, week 8, week 12 and at follow up at week 16
measure: Change in VASI (Vitiligo Area Scoring Index) compared to baseline for vitiligo
timeFrame: Week 0, week 4, week 8, week 12 and at follow up at week 16
Secondary outcomes:
measure: Colorimeter measurements
timeFrame: Week 0, week 4, week 8, week 12 and at follow up at week 16
Other outcomes:
measure: Physician Global Assessment
timeFrame: Week 16
measure: Patient global assessment
timeFrame: Week 16
Locations:
city: Vancouver
country: Canada
facility: The Skin Care Centre, Vancouver General Hospital
state: British Columbia
Study officials:
References: