Recruiting

Red Light

Sponsor:

University of British Columbia

Code:

NCT04308421

Conditions

Melasma

Lichen Planus Pigmentosus

Vitiligo

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Red light

Study Details

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.

Conditions

Melasma

Lichen Planus Pigmentosus

Vitiligo

Study ID

NCT04308421

Start date

Mar 1, 2020

Status verified date

Mar, 2020

Completion date

Sep, 2020

Anticipated

Primary completion date

Sep, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

Interventions

Red light

Low irradiation 650 nm +/- 5 nm red light

Primary outcome measure

  • Change in Modified-MASI (Melasma Area and Severity Index) compared to baseline for melasma and lichen planus pigmentosus [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Week 0, week 4, week 8, week 12 and at follow up at week 16 ]

Central Contacts and Locations

Central contacts

Sunil Kalia, MD MHSc FRCPC

+1 604-875-4747sunil.kalia@ubc.ca

Locations

The Skin Care Centre, Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E8

Contacts

Sunil Kalia, MD MHSc FRCPC

+1 604-875-4747sunil.kalia@ubc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Mar 16, 2020

Last verified

Mar, 2020

Keywords

  • Melasma
  • Lichen planus pigmentosus
  • Vitiligo
  • Low level laser therapy
  • Photobiomodulation
  • Red light
  • Pigmentation disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by University of British Columbia on 2020-03-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.