Modulated Light Therapy in Participants With Pattern Hair Loss

Androgenetic Alopecia Clinical Trial

Official title:

A Prospective, Randomized, Controlled, Double-Blind Study That Evaluates the Safety and Efficacy of Three Active REVIAN Caps Versus a Non-Active REVIAN Cap (Sham) in Participants With Pattern Hair Loss (Androgenic Alopecia)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04019795
• Other study ID #: REV-01
• Status: Completed
• Phase: Phase 3
• Start date: January 5, 2017
• Est. completion date: May 25, 2019

Study information

• Verified date: July 2019
• Source: PhotonMD, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The REVIAN study is designed as a prospective, randomized, controlled, double-blind, parallel study to evaluate the efficacy and safety of the REVIAN System in male participants with androgenic alopecia. An Active modulated light therapy REVIAN System will be compared to a Placebo Comparator non-active REVIAN System in participants using the device for a daily 10-minute treatment over the course of 26-weeks. At each follow-up visit, participants will be interviewed to determine if any adverse events (AEs) were experienced since the previous follow-up visit. All participants will be required to complete self-administering scalp hair growth and life quality questionnaires at each follow-up visit. Investigators will be required to complete global assessments of scalp hair growth for each enrolled participant at each follow-up visit. Macrophotography evaluations will be performed at baseline, 8-, 16-, and 26 weeks for all participants using standard Canfield blinded reviewer. Global photographs of superior and vertex scalp will be taken by participants and by PI to be assessed by a blinded reviewer once all photos have been captured for each participant per visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: May 25, 2019
• Est. primary completion date: May 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• The study population will consist of adult men and women between 18 and 65 years of age with diagnosis of Androgenic Alopecia, consistent with males who have Norwood Hamilton Classification IIa to V patterns of hair loss and females who have Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal, both with Fitzpatrick Skin Types I - IV. Participants agree to undergo all study procedures including global photographs of hair loss/growth, placement of a 1 mm tattoo dot placed on the scalp for macrophotography, refrain from using all other hair growth products or treatments (oral or topical medication including over the counter herbal medications, or Dutasteride), avoid the use of wigs, hairpieces, and/or hair extensions during the study, return for all the required follow-up visits, and in the opinion of the Clinical Investigator, are able to understand this clinical investigation and cooperate with the investigational procedures.

Exclusion Criteria:

• Participants with 12 month history of taking Propecia or any other hair growth supplements including Rogaine or Minoxidil based products for 6-months prior to enrollment, having previous hair transplant, cell treatment, micro-needling, tattooing, or any other treatment to the scalp, suffering from an active autoimmune disease such as serum lupus erythematosus or alopecia areata, photosensitivity to visible light, currently suffering from a dermatological condition in the treatment area or has a significant scar in the hair treatment area that will make hair growth difficult (such as a systemic burn, malignancy, etc.), has a sensitivity or allergy to tattoo ink, using any medication deemed to inhibit hair growth as determined by the physician investigator, or have had radiation or chemotherapy in the last 12 months will be excluded.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

Device:
• REVIAN 101
The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites. REVIAN 101 delivers 625 nm and 660 nm wavelengths of red light.
• REVIAN 102
The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites. REVIAN 102 delivers 425 nm wavelength of blue light.
• REVIAN 103
The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites. REVIAN 103 delivers 425 nm wavelength of blue light and 625 nm and 660 nm wavelengths of red light.
• REVIAN 100
The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites. REVIAN 100 contains LEDs that are not powered for light therapy

Locations

Country	Name	City	State
Australia	The Skin Hospital	Darlinghurst	New South Wales
Australia	Premier Specialists	Kogarah	New South Wales
Australia	Sinclair Dermatology	Sydney	New South Wales
Australia	Veracity Clinical Research Pty Ltd	Woolloongabba	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
PhotonMD, Inc

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Terminal Hair Count from Baseline to 16 Weeks	The primary efficacy outcome of this study is mean change in hair count from baseline. Standardized Canfield macro-photographs will be taken to capture digital images at baseline and will be compared to images captured at various endpoints throughout the study. Multiple images will be taken at each endpoint and will be reviewed by independent blinded observers to conduct the hair count	Primary endpoint is 16-weeks follow-up from the initial application at baseline