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Trial record 1 of 155 for:    Modulated Light Therapy | Completed Studies
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Modulated Light Therapy in Participants With Pattern Hair Loss

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ClinicalTrials.gov Identifier: NCT04019795
Recruitment Status : Completed
First Posted : July 15, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
PhotonMD, Inc

Tracking Information
First Submitted Date  ICMJE July 11, 2019
First Posted Date  ICMJE July 15, 2019
Last Update Posted Date July 15, 2019
Actual Study Start Date  ICMJE January 5, 2017
Actual Primary Completion Date May 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
Mean Change in Terminal Hair Count from Baseline to 16 Weeks [ Time Frame: Primary endpoint is 16-weeks follow-up from the initial application at baseline ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modulated Light Therapy in Participants With Pattern Hair Loss
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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)
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.
Primary Purpose: Treatment
Condition  ICMJE Androgenetic Alopecia
Intervention  ICMJE
  • 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.

  • Device: 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.

  • Device: 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.

  • Device: 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

Study Arms  ICMJE
  • Sham Comparator: Non-Active REVIAN (Sham) Cap 100
    Sham (Control) Group
    Intervention: Device: REVIAN 100
  • Experimental: Active REVIAN Cap 101
    (625 nm and 660 nm)
    Intervention: Device: REVIAN 101
  • Experimental: Active REVIAN Cap 102
    (425 nm)
    Intervention: Device: REVIAN 102
  • Experimental: Active REVIAN Cap 103
    (425 nm, 625 nm and 660 nm)
    Intervention: Device: REVIAN 103
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2019)
161
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 25, 2019
Actual Primary Completion Date May 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04019795
Other Study ID Numbers  ICMJE REV-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party PhotonMD, Inc
Study Sponsor  ICMJE PhotonMD, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account PhotonMD, Inc
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP