Efficacy of Red Light in the Treatment of Pigmentary Disorders

NCT ID: NCT04308421

Last Updated: 2020-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2020-09-30

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.

Conditions

Melasma; Lichen Planus Pigmentosus; Vitiligo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Red light

Intervention Type: DEVICE

Low irradiation 650 nm +/- 5 nm red light

Control side

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Red light

Low irradiation 650 nm +/- 5 nm red light

Intervention Type: DEVICE

Other Intervention Names

Low level laser therapy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Sunil Kalia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Skin Care Centre, Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Sunil Kalia, MD MHSc FRCPC

Role: CONTACT

sunil.kalia@ubc.ca

+1 604-875-4747

Facility Contacts

Sunil Kalia, MD MHSc FRCPC

Role: primary

sunil.kalia@ubc.ca

+1 604-875-4747

Other Identifiers

H20-00293

Identifier Type: -

Identifier Source: org_study_id