Modulated Light Therapy in Participants With Pattern Hair Loss

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)

Sponsors

Lead Sponsor: PhotonMD, Inc

Source PhotonMD, Inc
Brief 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.

Overall Status Completed
Start Date January 5, 2017
Completion Date May 25, 2019
Primary Completion Date May 25, 2019
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean Change in Terminal Hair Count from Baseline to 16 Weeks Primary endpoint is 16-weeks follow-up from the initial application at baseline
Enrollment 161
Condition
Intervention

Intervention Type: Device

Intervention Name: REVIAN 101

Description: 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.

Arm Group Label: Active REVIAN Cap 101

Intervention Type: Device

Intervention Name: REVIAN 102

Description: 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.

Arm Group Label: Active REVIAN Cap 102

Intervention Type: Device

Intervention Name: REVIAN 103

Description: 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.

Arm Group Label: Active REVIAN Cap 103

Intervention Type: Device

Intervention Name: REVIAN 100

Description: 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

Arm Group Label: Non-Active REVIAN (Sham) Cap 100

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Location
Facility:
The Skin Hospital | Darlinghurst, New South Wales, 2010, Australia
Premier Specialists | Kogarah, New South Wales, 2217, Australia
Sinclair Dermatology | Sydney, New South Wales, 2064, Australia
Veracity Clinical Research Pty Ltd | Woolloongabba, Queensland, 4102, Australia
Location Countries

Australia

Verification Date

July 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Non-Active REVIAN (Sham) Cap 100

Type: Sham Comparator

Description: Sham (Control) Group

Label: Active REVIAN Cap 101

Type: Experimental

Description: (625 nm and 660 nm)

Label: Active REVIAN Cap 102

Type: Experimental

Description: (425 nm)

Label: Active REVIAN Cap 103

Type: Experimental

Description: (425 nm, 625 nm and 660 nm)

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: 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.

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description: The allocation was concealed by numbered device containers and is distributed by unblinded study administrators who are not involved with the interview of participants for study eligibility.

Source: ClinicalTrials.gov