Androgenetic Alopecia
Conditions
Keywords
Hair Loss, Pattern Hair Loss, LED, Modulated Light Therapy, Red Light
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.
Interventions
DEVICEREVIAN 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.
DEVICEREVIAN 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.
DEVICEREVIAN 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.
DEVICEREVIAN 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
Sponsors
Avania
Applied Statistics and Consulting
Trilogic
Catalyst Pharmaceutical Research
PhotonMD, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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. Candidates for this study must meet ALL of the following criteria: 1. Male and Female participants between 18 and 65 years of age 2. Must be able to read and speak English. 3. Participants who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained. 4. Participants, who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures and are willing to return for all the required follow-up visits. 5. Participant must be able to visit clinic site at 8-, 16- and 26-weeks study visits and be available by phone at 4 weeks. 6. Participant must have the ability to communicate effectively with study personnel in person or over the phone. 7. Participant must have diagnosis of Androgenic Alopecia (pattern hair loss). 8. Participant must have active hair loss consistent with Grades IIa to V, based on Norwood- Hamilton Scale or Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal and Grades I - IV using Fitzpatrick Skin Type Scale. 9. Participant's hair must be at least 1 inch in length. The hair style and length shall be the same for each follow-up visit. Participants will be instructed to not have their hair cut/styled within 5 days prior to a follow-up visit. 10. Participant is willing to have a dot tattoo placed on or around the target area of the scalp. 11. Participant is willing to undergo all study procedures including consent for global photographs of hair loss/growth and a 1 mm tattoo to mark the macrophotography site along the indicated transition area of the scalp between the hairline and the balding/thinning vertex area. 12. Participant is willing to avoid the use of wigs, hairpieces, and/or hair extensions during the study period. 13. Hair Specific Skindex-29 Quality of Life total overall score of ≥ 45. 14. Participant is willing to maintain their natural hair colour or including the use of coloring throughout the study period. 15. Participant agrees to refrain from using all other hair growth products or treatments (oral or topical medication including over the counter herbal medications, or Dutasteride) during the study period. 16. Participant has the ability to utilize a Bluetooth device and application on a smart device connected to Wi-Fi.
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. Candidates will be excluded from the study if ANY of the following apply: 1. Female participants of childbearing potential who are not on some form of birth control and do not have a confirmed negative pregnancy test at baseline 2. Use of Propecia or any other hair growth supplements within 12 months prior to enrollment. 3. Use of Rogaine or Minoxidil based products within 6 months prior to enrollment. 4. Participants have a previous hair transplant, cell treatment, micro needling, tattooing, or any other treatment to the scalp. 5. Participant is suffering from an active autoimmune disease such as lupus erythematosus (systemic and cutaneous) or alopecia areata. 6. Photosensitivity to visible light operating within 400 - 850 nm or taking medication that REVIAN® Trial Confidential and Proprietary Page 23 of 55 Version 6.0 2018-08-22 increases photosensitivity. 7. Currently suffering from a dermatological condition in the treatment area or has a significant scar in the hair treatment area that, in the opinion of the investigator, will make hair growth difficult (such as a systemic burn, malignancy, etc.) 8. Participant has a sensitivity or allergy to tattoo ink. 9. Using any medication deemed to inhibit hair growth as determined by the physician investigator. 10. Employed by the sponsor, clinic site, or entity associated with the conduct of the study. 11. Has had radiation or chemotherapy in the last 12 months. 12. Have any condition or situation which, in the Investigator's opinion, puts the participant at significant risk, could confound the study results, or may interfere significantly with the participant's participation in the study. 13. Known prior inability to complete required study visits during treatment period; 14. Use of any other investigational drug, therapy, or device within the past 30 days of enrollment or concurrent participation in another research study; 15. Are unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function; 16. Participants who are currently involved in any investigational drug or device trial or have been enrolled in such trials within the last 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Terminal Hair Count From Baseline to 16 Weeks | Primary efficacy 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 |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-Active REVIAN (Sham) Cap 100 Sham (Control) Group
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 | 42 |
| Active REVIAN Cap 101 (1.67mW/cm2 of 625 nm and 660 nm)
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. | 39 |
| Active REVIAN Cap 102 (1.67mW/cm2 of 625 of 425 nm)
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. | 41 |
| Active REVIAN Cap 103 (1.67mW/cm2 of 425 + 1.67mW/cm2 of 625 nm and 660 nm)
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. | 38 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 1 | 2 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 0 |
| Overall Study | Treatment non-compliance | 3 | 1 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 2 | 1 |
Baseline characteristics
| Characteristic | Non-Active REVIAN (Sham) Cap 100 | Total | Active REVIAN Cap 103 | Active REVIAN Cap 102 | Active REVIAN Cap 101 |
|---|---|---|---|---|---|
| Age, Continuous | 43.9 years STANDARD_DEVIATION 12.06 | 42.5 years STANDARD_DEVIATION 12.2 | 42.6 years STANDARD_DEVIATION 10.41 | 45.4 years STANDARD_DEVIATION 9.71 | 41 years STANDARD_DEVIATION 12.3 |
| Fitzpatrick Skin Type Type I | 1 Participants | 5 Participants | 3 Participants | 0 Participants | 1 Participants |
| Fitzpatrick Skin Type Type II | 15 Participants | 56 Participants | 13 Participants | 15 Participants | 13 Participants |
| Fitzpatrick Skin Type Type III | 14 Participants | 58 Participants | 13 Participants | 17 Participants | 14 Participants |
| Fitzpatrick Skin Type Type IV | 12 Participants | 41 Participants | 9 Participants | 9 Participants | 11 Participants |
| Hamilton-Norwood Hair Loss Scale IIa | 2 participants | 8 participants | 3 participants | 0 participants | 3 participants |
| Hamilton-Norwood Hair Loss Scale III | 3 participants | 14 participants | 5 participants | 2 participants | 4 participants |
| Hamilton-Norwood Hair Loss Scale IIIa | 1 participants | 5 participants | 1 participants | 3 participants | 0 participants |
| Hamilton-Norwood Hair Loss Scale III vertex | 12 participants | 34 participants | 6 participants | 9 participants | 7 participants |
| Hamilton-Norwood Hair Loss Scale IV | 5 participants | 36 participants | 11 participants | 10 participants | 10 participants |
| Hamilton-Norwood Hair Loss Scale IVa | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Hamilton-Norwood Hair Loss Scale V | 7 participants | 24 participants | 4 participants | 6 participants | 7 participants |
| Ludwig-Savin Scale I-1 | 2 participants | 2 participants | 0 participants | 0 participants | 0 participants |
| Ludwig-Savin Scale I-2 | 1 participants | 5 participants | 1 participants | 2 participants | 1 participants |
| Ludwig-Savin Scale I-3 | 1 participants | 6 participants | 2 participants | 2 participants | 1 participants |
| Ludwig-Savin Scale I-4 | 2 participants | 10 participants | 3 participants | 2 participants | 3 participants |
| Ludwig-Savin Scale II-1 | 3 participants | 6 participants | 1 participants | 1 participants | 1 participants |
| Ludwig-Savin Scale II-2 | 3 participants | 10 participants | 1 participants | 4 participants | 2 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 19 Participants | 2 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 22 Participants | 7 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) White | 29 Participants | 118 Participants | 29 Participants | 31 Participants | 29 Participants |
| Region of Enrollment Australia | 42 Participants | 160 Participants | 38 Participants | 41 Participants | 39 Participants |
| Sex: Female, Male Female | 12 Participants | 40 Participants | 8 Participants | 11 Participants | 9 Participants |
| Sex: Female, Male Male | 30 Participants | 120 Participants | 30 Participants | 30 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 39 | 0 / 41 | 0 / 38 |
| other Total, other adverse events | 10 / 42 | 8 / 39 | 7 / 41 | 5 / 38 |
| serious Total, serious adverse events | 1 / 42 | 0 / 39 | 2 / 41 | 0 / 38 |
Outcome results
Primary
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
Time frame: Primary efficacy endpoint is 16-weeks follow-up from the initial application at baseline
Population: Per Protocol with at least 80% treatment compliance as measured by the Revian mobile app
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Non-Active REVIAN (Sham) Cap 100 | Mean Change in Terminal Hair Count From Baseline to 16 Weeks | -15.53 Change in total hair counts | Standard Error 11.3 |
| Active REVIAN Cap 101 | Mean Change in Terminal Hair Count From Baseline to 16 Weeks | 14.26 Change in total hair counts | Standard Error 11.3 |
| Active REVIAN Cap 102 | Mean Change in Terminal Hair Count From Baseline to 16 Weeks | 18.94 Change in total hair counts | Standard Error 12 |
| Active REVIAN Cap 103 | Mean Change in Terminal Hair Count From Baseline to 16 Weeks | 5.22 Change in total hair counts | Standard Error 11.6 |