Androgenetic AlopeciaREV-01NCT04019795
Modulated Light Therapy in Participants With Pattern Hair Loss
A study testing REVIAN 101, REVIAN 102 and REVIAN 103 in people with Androgenetic Alopecia, run by PhotonMD, Inc at 4 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- REVIAN 101, REVIAN 102 and REVIAN 103
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 4 sitesAustralia
- Study dates
- 5 Jan 2017to 25 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Male and Female participants between 18 and 65 years of age
- Must be able to read and speak English.
- Participants who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- 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.
Show all 18Show fewer
- Participant must be able to visit clinic site at 8-, 16- and 26-weeks study visits and be available by phone at 4 weeks.
- Participant must have the ability to communicate effectively with study personnel in person or over the phone.
- Participant must have diagnosis of Androgenic Alopecia (pattern hair loss).
- 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.
- 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.
- Participant is willing to have a dot tattoo placed on or around the target area of the scalp.
- 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.
- Participant is willing to avoid the use of wigs, hairpieces, and/or hair extensions during the study period.
- Hair Specific Skindex-29 Quality of Life total overall score of ≥ 45.
- Participant is willing to maintain their natural hair colour or including the use of coloring throughout the study period.
- 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.
- Participant has the ability to utilize a Bluetooth device and application on a smart device connected to Wi-Fi.
Who cannot join
- 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:
- 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
- Use of Propecia or any other hair growth supplements within 12 months prior to enrollment.
- Use of Rogaine or Minoxidil based products within 6 months prior to enrollment.
- Participants have a previous hair transplant, cell treatment, micro needling, tattooing, or any other treatment to the scalp.
Show all 18Show fewer
- Participant is suffering from an active autoimmune disease such as lupus erythematosus (systemic and cutaneous) or alopecia areata.
- 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.
- 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.)
- Participant has a sensitivity or allergy to tattoo ink.
- Using any medication deemed to inhibit hair growth as determined by the physician investigator.
- Employed by the sponsor, clinic site, or entity associated with the conduct of the study.
- Has had radiation or chemotherapy in the last 12 months.
- 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.
- Known prior inability to complete required study visits during treatment period;
- Use of any other investigational drug, therapy, or device within the past 30 days of enrollment or concurrent participation in another research study;
- Are unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function;
- Participants who are currently involved in any investigational drug or device trial or have been enrolled in such trials within the last 3 months.
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
The Skin Hospital
Darlinghurst, New South Wales, 2010
Premier Specialists
Kogarah, New South Wales, 2217
Sinclair Dermatology
Sydney, New South Wales, 2064
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, 4102
About this study
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)
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.
- Conditions
- Androgenetic Alopecia
- Being tested
- REVIAN 101, REVIAN 102, REVIAN 103, REVIAN 100
- Keywords
- Hair Loss, Pattern Hair Loss, LED, Modulated Light Therapy, Red Light
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REVIAN 101Device
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.
REVIAN 102Device
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.
REVIAN 103Device
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.
REVIAN 100Device
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 group | Role | What they receive |
|---|---|---|
| Non-Active REVIAN (Sham) Cap 100 | Sham comparator | Sham (Control) Group Receives: Device: REVIAN 100 |
| Active REVIAN Cap 101 | Experimental | (625 nm and 660 nm) Receives: Device: REVIAN 101 |
| Active REVIAN Cap 102 | Experimental | (425 nm) Receives: Device: REVIAN 102 |
| Active REVIAN Cap 103 | Experimental | (425 nm, 625 nm and 660 nm) Receives: Device: REVIAN 103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Primary efficacy endpoint is 16-weeks follow-up from the initial application at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start5 Jan 2017
- Primary completion25 May 2019
- Study completion25 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhotonMD, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania, Applied Statistics and Consulting, Trilogic, Catalyst Pharmaceutical Research
- Responsible party
- Sponsor
- Investigators
- Rodney D Sinclair, MD, Principal investigator, Sinclair Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019795
- Sponsor's protocol ID
- REVIAN Trial
- Acronym
- REV-01
- Status last verified
- Aug 2024
- First submitted
- 11 Jul 2019
- Last updated
- 5 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04019795
- Acronym / sponsor ID
- REV-01 / REVIAN Trial
- Conditions
- Androgenetic Alopecia
- Keywords
- Hair Loss, Pattern Hair Loss, LED, Modulated Light Therapy, Red Light
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- PhotonMD, IncIndustry (pharma, biotech, devices)
- Collaborators
- Avania, Applied Statistics and Consulting, Trilogic, Catalyst Pharmaceutical Research
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 25 May 2019 (actual)
- Study completion
- 25 May 2019 (actual)
- First posted
- 15 Jul 2019 (actual)
- Results
- Posted 5 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Non-Active REVIAN (Sham) Cap 100 | Sham comparator | Device: REVIAN 100Sham (Control) Group |
| Active REVIAN Cap 101 | Experimental | Device: REVIAN 101(625 nm and 660 nm) |
| Active REVIAN Cap 102 | Experimental | Device: REVIAN 102(425 nm) |
| Active REVIAN Cap 103 | Experimental | Device: REVIAN 103(425 nm, 625 nm and 660 nm) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
- Male and Female participants between 18 and 65 years of age
- Must be able to read and speak English.
- Participants who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- 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.
Key exclusion criteria (18 listed)
- 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.
- 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
- Use of Propecia or any other hair growth supplements within 12 months prior to enrollment.
- Use of Rogaine or Minoxidil based products within 6 months prior to enrollment.
- Participants have a previous hair transplant, cell treatment, micro needling, tattooing, or any other treatment to the scalp.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REVIAN 101The 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 | Active REVIAN Cap 101 |
| REVIAN 102The 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 | Active REVIAN Cap 102 |
| REVIAN 103The 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 | Active REVIAN Cap 103 |
| REVIAN 100The 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 | Device | Non-Active REVIAN (Sham) Cap 100 |
Primary outcome
Mean Change in Terminal Hair Count From Baseline to 16 Weeks
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Androgenetic Alopecia
Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodney D Sinclair, MD principal investigator
Sinclair Dermatology
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REVIAN 101, REVIAN 102 and REVIAN 103 in people with Androgenetic Alopecia, run by PhotonMD, Inc at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Terminal Hair Count From Baseline to 16 Weeks (time frame: Primary efficacy endpoint is 16-weeks follow-up from the initial application at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.