Melasma, Lichen Planus Pigmentosus, Vitiligo
Conditions
Keywords
Melasma, Lichen planus pigmentosus, Vitiligo, Low level laser therapy, Photobiomodulation, Red light, Pigmentation disorders
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.
Interventions
DEVICERed light
Low irradiation 650 nm +/- 5 nm red light
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Modified-MASI (Melasma Area and Severity Index) compared to baseline for melasma and lichen planus pigmentosus | Week 0, week 4, week 8, week 12 and at follow up at week 16 | 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 |
| Change in DPASI (Dermal Pigmentation Area and Severity score) compared to baseline for lichen planus pigmentosus | Week 0, week 4, week 8, week 12 and at follow up at week 16 | 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 |
| Change in VASI (Vitiligo Area Scoring Index) compared to baseline for vitiligo | Week 0, week 4, week 8, week 12 and at follow up at week 16 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Colorimeter measurements | Week 0, week 4, week 8, week 12 and at follow up at week 16 | Change in average L\*a\*b color system will be measured for background skin and the area of hyperpigmentation or depigmentation from baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Physician Global Assessment | Week 16 | Physician global assessment at the end of treatment at follow up will be assessed to identify change in pigmentation compared to baseline photographs. |
| Patient global assessment | Week 16 | — |
Countries
Canada
Contacts
Primary ContactSunil Kalia, MD MHSc FRCPC
Outcome results
None listed