An interventional study of Red light in Melasma, Lichen Planus Pigmentosus and Vitiligo, sponsored by University of British Columbia. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-16.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
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.
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.
159 studies on the registry are indexed under Melanosis; 42 are open to participants now.
This study's planned enrollment of 45 is above the median of 40 across 149 interventional studies indexed under Melanosis.
Browse Melanosis studies →University of British Columbia is the lead sponsor of 1,335 studies on the registry; 255 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
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
Device: Red light
An affected area on the contralateral side of the face or body or within a single patch will not be treated
Low irradiation 650 nm +/- 5 nm red light
Also known as: Low level laser therapy
Change in Modified-MASI (Melasma Area and Severity Index) compared to baseline for melasma and lichen planus pigmentosus
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
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
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
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
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
Time frame: Week 0, week 4, week 8, week 12 and at follow up at week 16
Colorimeter measurements
Change in average L\*a\*b color system will be measured for background skin and the area of hyperpigmentation or depigmentation from baseline.
Time frame: Week 0, week 4, week 8, week 12 and at follow up at week 16
Physician Global Assessment
Physician global assessment at the end of treatment at follow up will be assessed to identify change in pigmentation compared to baseline photographs.
Time frame: Week 16
Patient global assessment
Time frame: Week 16
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2020 (actual). Primary completion is estimated for Sep 2020, 6 months after the start.
Of 34 non-industry interventional studies with no phase under Melanosis, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 19. This study's planned 6 months is below that.
Counting every sponsor, half of 49 studies reached it within 9 months; a quarter within 5 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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