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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04019795




Registration number
NCT04019795
Ethics application status
Date submitted
11/07/2019
Date registered
15/07/2019
Date last updated
5/09/2024

Titles & IDs
Public title
Modulated Light Therapy in Participants With Pattern Hair Loss
Scientific 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)
Secondary ID [1] 0 0
REVIAN Trial
Universal Trial Number (UTN)
Trial acronym
REV-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Androgenetic Alopecia 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - REVIAN 101
Treatment: Devices - REVIAN 102
Treatment: Devices - REVIAN 103
Treatment: Devices - REVIAN 100

Sham comparator: Non-Active REVIAN (Sham) Cap 100 - Sham (Control) Group

Experimental: Active REVIAN Cap 101 - (625 nm and 660 nm)

Experimental: Active REVIAN Cap 102 - (425 nm)

Experimental: Active REVIAN Cap 103 - (425 nm, 625 nm and 660 nm)


Treatment: Devices: 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.

Treatment: Devices: 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.

Treatment: Devices: 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.

Treatment: Devices: 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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change in Terminal Hair Count from Baseline to 16 Weeks
Timepoint [1] 0 0
Primary endpoint is 16-weeks follow-up from the initial application at baseline

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/05/2019
Sample size
Target
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
The Skin Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Premier Specialists - Kogarah
Recruitment hospital [3] 0 0
Sinclair Dermatology - Sydney
Recruitment hospital [4] 0 0
Veracity Clinical Research Pty Ltd - Woolloongabba
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2064 - Sydney
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
PhotonMD, Inc
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04019795
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rodney D Sinclair, MD
Address 0 0
Sinclair Dermatology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04019795