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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low level red light/laser | Experimental | 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 |
|
| Control side | No Intervention | An affected area on the contralateral side of the face or body or within a single patch will not be treated |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Red light | Device | Low irradiation 650 nm +/- 5 nm red light |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | Week 0, week 4, week 8, week 12 and at follow up at week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 0, week 4, week 8, week 12 and at follow up at week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 16 |
| Patient global assessment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sunil Kalia, MD MHSc FRCPC | Contact | +1 604-875-4747 | sunil.kalia@ubc.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Skin Care Centre, Vancouver General Hospital | Recruiting | Vancouver | British Columbia | V5Z 4E8 | Canada |
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| ID | Term |
|---|---|
| D008548 | Melanosis |
| D014820 | Vitiligo |
| D010859 | Pigmentation Disorders |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017496 | Hypopigmentation |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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| Week 16 |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |