Modulated Light Therapy in Participants With Pattern Hair Loss

Brief Title

Modulated Light Therapy in Participants With Pattern Hair Loss

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)

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.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Mean Change in Terminal Hair Count from Baseline to 16 Weeks

Condition

Androgenetic Alopecia

Intervention

REVIAN 101

Study Arms / Comparison Groups

 Non-Active REVIAN (Sham) Cap 100

Description:  Sham (Control) Group

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Device

Estimated Enrollment

161

Start Date

January 5, 2017

Completion Date

May 25, 2019

Primary Completion Date

May 25, 2019

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

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

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Location Countries

Australia

Location Countries

Australia

NCT ID

NCT04019795

Organization ID

REV-01

Responsible Party

Sponsor

Study Sponsor

PhotonMD, Inc

Study Sponsor

, , 

Verification Date

July 2019