Efficacy of Red Light in the Treatment of Pigmentary Disorders

University of British Columbia

Status: Unknown

Conditions: Lichen Planus Pigmentosus; Vitiligo; Melasma

Treatments: Device: Red light

Study type: Interventional

Funder types: Other

Identifiers

NCT04308421

H20-00293

Details and patient eligibility

About

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 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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45 participants in 2 patient groups

Low level red light/laser

Experimental group

Description:

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

Treatment:

Device: Red light

Control side

No Intervention group

Description:

An affected area on the contralateral side of the face or body or within a single patch will not be treated