Back to resultsEfficacy of Red Light in the Treatment of Pigmentary Disorders
Primary Purpose
Melasma, Lichen Planus Pigmentosus, Vitiligo
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Red light
Sponsored by
About this trial
This is an interventional treatment trial for Melasma focused on measuring Melasma, Lichen planus pigmentosus, Vitiligo, Low level laser therapy, Photobiomodulation, Red light, Pigmentation disorders
Eligibility Criteria
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
Sites / Locations
- The Skin Care Centre, Vancouver General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Low level red light/laser
Control side
Arm Description
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
An affected area on the contralateral side of the face or body or within a single patch will not be treated
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04308421
First Posted
February 25, 2020
Last Updated
March 11, 2020
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT04308421
Brief Title
Efficacy of Red Light in the Treatment of Pigmentary Disorders
Official Title
A Prospective, Double-blind, Split-body, Randomized Controlled Trial to Assess the Efficacy of Low Level Laser Therapy for Pigmentary Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma, Lichen Planus Pigmentosus, Vitiligo
Keywords
Melasma, Lichen planus pigmentosus, Vitiligo, Low level laser therapy, Photobiomodulation, Red light, Pigmentation disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low level red light/laser
Arm Type
Experimental
Arm Description
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
Arm Title
Control side
Arm Type
No Intervention
Arm Description
An affected area on the contralateral side of the face or body or within a single patch will not be treated
Intervention Type
Device
Intervention Name(s)
Red light
Other Intervention Name(s)
Low level laser therapy
Intervention Description
Low irradiation 650 nm +/- 5 nm red light
Primary Outcome Measure Information:
Title
Change in Modified-MASI (Melasma Area and Severity Index) compared to baseline for melasma and lichen planus pigmentosus
Description
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
Title
Change in DPASI (Dermal Pigmentation Area and Severity score) compared to baseline for lichen planus pigmentosus
Description
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
Title
Change in VASI (Vitiligo Area Scoring Index) compared to baseline for vitiligo
Description
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
Secondary Outcome Measure Information:
Title
Colorimeter measurements
Description
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
Other Pre-specified Outcome Measures:
Title
Physician Global Assessment
Description
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
Title
Patient global assessment
Time Frame
Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sunil Kalia, MD MHSc FRCPC
Phone
+1 604-875-4747
Email
sunil.kalia@ubc.ca
Facility Information:
Facility Name
The Skin Care Centre, Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunil Kalia, MD MHSc FRCPC
Phone
+1 604-875-4747
Email
sunil.kalia@ubc.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Red Light in the Treatment of Pigmentary Disorders
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