Back to resultsModulated Light Therapy in Participants With Pattern Hair Loss
Primary Purpose
Androgenetic Alopecia
Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
REVIAN 101
REVIAN 102
REVIAN 103
REVIAN 100
Sponsored by
About this trial
This is an interventional treatment trial for Androgenetic Alopecia focused on measuring Hair Loss, Pattern Hair Loss, LED, Modulated Light Therapy, Red Light
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.
Sites / Locations
- The Skin Hospital
- Premier Specialists
- Sinclair Dermatology
- Veracity Clinical Research Pty Ltd
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Sham Comparator
Experimental
Experimental
Experimental
Arm Label
Non-Active REVIAN (Sham) Cap 100
Active REVIAN Cap 101
Active REVIAN Cap 102
Active REVIAN Cap 103
Arm Description
Sham (Control) Group
(625 nm and 660 nm)
(425 nm)
(425 nm, 625 nm and 660 nm)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04019795
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 5, 2017 (Actual)
Primary Completion Date
May 25, 2019 (Actual)
Study Completion Date
May 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PhotonMD, Inc
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
Keywords
Hair Loss, Pattern Hair Loss, LED, Modulated Light Therapy, Red Light
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
161 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-Active REVIAN (Sham) Cap 100
Arm Type
Sham Comparator
Arm Description
Sham (Control) Group
Arm Title
Active REVIAN Cap 101
Arm Type
Experimental
Arm Description
(625 nm and 660 nm)
Arm Title
Active REVIAN Cap 102
Arm Type
Experimental
Arm Description
(425 nm)
Arm Title
Active REVIAN Cap 103
Arm Type
Experimental
Arm Description
(425 nm, 625 nm and 660 nm)
Intervention Type
Device
Intervention Name(s)
REVIAN 101
Intervention 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.
Intervention Type
Device
Intervention Name(s)
REVIAN 102
Intervention 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.
Intervention Type
Device
Intervention Name(s)
REVIAN 103
Intervention 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.
Intervention Type
Device
Intervention Name(s)
REVIAN 100
Intervention 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
Primary Outcome Measure Information:
Title
Mean Change in Terminal Hair Count from Baseline to 16 Weeks
Description
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
Time Frame
Primary endpoint is 16-weeks follow-up from the initial application at baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
The Skin Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Premier Specialists
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Sinclair Dermatology
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2064
Country
Australia
Facility Name
Veracity Clinical Research Pty Ltd
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
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Modulated Light Therapy in Participants With Pattern Hair Loss
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