NCT04308421

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

March 16, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

February 25, 2020

Last Update Submit

March 11, 2020

Conditions

MelasmaLichen Planus PigmentosusVitiligo

Keywords

MelasmaLichen planus pigmentosusVitiligoLow level laser therapyPhotobiomodulationRed lightPigmentation disorders

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (1)

  • Colorimeter measurements

    Week 0, week 4, week 8, week 12 and at follow up at week 16

Other Outcomes (2)

  • Physician Global Assessment

    Week 16

  • Patient global assessment

    Week 16

Study Arms (2)

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

Device: Red light

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

Interventions

Red lightDEVICE

Low irradiation 650 nm +/- 5 nm red light

Also known as: Low level laser therapy
Low level red light/laser

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Known photosensitivity disorder
  • Unable to attend follow up appointments or twice weekly treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Skin Care Centre, Vancouver General Hospital

Vancouver, British Columbia, V5Z 4E8, Canada

RECRUITING

MeSH Terms

Conditions

MelanosisVitiligoPigmentation Disorders

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

HyperpigmentationSkin DiseasesSkin and Connective Tissue DiseasesHypopigmentationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Central Study Contacts

Sunil Kalia, MD MHSc FRCPC

CONTACT

+1 604-875-4747sunil.kalia@ubc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 25, 2020

First Posted

March 16, 2020

Study Start

March 1, 2020

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

March 16, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)