Modulated Light Therapy in Participants With Pattern Hair Loss
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 3

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.
    


Intervention name(s): REVIAN 101; REVIAN 102; REVIAN 103; REVIAN 100
Intervention type(s): Device; Device; Device; Device
Intervention description(s): 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.; 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.; 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.; 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
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.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hair Loss; Pattern Hair Loss; LED; Modulated Light Therapy; Red Light