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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04308421
Other study ID # H20-00293
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2020
Est. completion date September 2020

Study information

Verified date March 2020
Source University of British Columbia
Contact Sunil Kalia, MD MHSc FRCPC
Phone +1 604-875-4747
Email sunil.kalia@ubc.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date September 2020
Est. primary completion date September 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Device:
Red light
Low irradiation 650 nm +/- 5 nm red light

Locations

Country Name City State
Canada The Skin Care Centre, Vancouver General Hospital Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other Patient global assessment Week 16
Primary 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
Primary 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
Primary 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
Secondary 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
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