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Trial registered on ANZCTR


Registration number
ACTRN12617000775314
Ethics application status
Approved
Date submitted
19/05/2017
Date registered
26/05/2017
Date last updated
27/06/2019
Date data sharing statement initially provided
27/06/2019
Type of registration
Retrospectively registered

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] 291992 0
REV-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Androgenic Alopecia 303349 0
Condition category
Condition code
Human Genetics and Inherited Disorders 302775 302775 0 0
Other human genetics and inherited disorders
Skin 302842 302842 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 298114 0
Treatment: Devices
Comparator / control treatment
The Comparator Sham Control group uses a non-active REVIAN Cap with LEDs that are not powered with modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 302167 0
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.
Timepoint [1] 302167 0
Primary endpoint is 16-weeks follow-up from the initial application at baseline.
Secondary outcome [1] 335026 0
Quantitative Scalp Hair Growth: Changes in terminal hair count. Terminal hair counts (non-vellus/non-miniaturized greater than or equal to 0.03 mm) will be assessed in the target region with macrophotography.
Timepoint [1] 335026 0
Quantitative Scalp Hair Growth at 8 and 26 weeks over baseline
Secondary outcome [2] 335027 0
Physician's Global Assessment (PGA): Determination of hair growth over baseline through global photographic review by blinded reviewer(s).
Timepoint [2] 335027 0
PGA at 8-weeks, 16-weeks, and 26-weeks
Secondary outcome [3] 335028 0
Hair Specific Skindex-29 Quality of Life Score by participants.
Timepoint [3] 335028 0
Hair Specific Skindex-29 QOL Score at 8-, 16- and 26-weeks.

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.
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.

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)
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary effectiveness outcome will be the difference between study groups in the change between baseline and the average of the 16-week follow-up terminal hair counts. The sample size for this study is based on the primary efficacy endpoint of mean change in hair count from baseline to 16-weeks following the initial application at baseline. Calculations are based on a Pearson chi-square test assuming a 1:1 randomization ratio between active comparators to the sham control.

The study design is a 4-arm study of a superiority of an active device to Sham group with a maximum of 50 participants per arm. Each active device group is independently compared to Sham group. Assumptions are 15 hair difference between treatments, SD=20, 10% drop-out rate, 5% alpha level, 90% power and 2-sided t-test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/05/2017
Date of last participant enrolment
Anticipated
14/12/2018
Actual
29/01/2019
Date of last data collection
Anticipated
6/06/2019
Actual
27/05/2019
Sample size
Target
200
Accrual to date
Final
161
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 8041 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [2] 8042 0
Veracity Clinical Research - Woolloongabba
Recruitment postcode(s) [1] 16082 0
3002 - East Melbourne
Recruitment postcode(s) [2] 16084 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 16179 0
2217 - Kogarah Bay

Funding & Sponsors
Funding source category [1] 296507 0
Commercial sector/Industry
Name [1] 296507 0
PhotonMD, Inc.
Country [1] 296507 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Five Corners Pty Ltd
Address
13/76 Reserve Road
Artarmon, Sydney
NSW 2064
Country
Australia
Secondary sponsor category [1] 295468 0
None
Name [1] 295468 0
Address [1] 295468 0
Country [1] 295468 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297729 0
Bellberry Human Research Ethics Committee (HREC)
Ethics committee address [1] 297729 0
129 Glen Osmond Rd
Eastwood SA 5063
Ethics committee country [1] 297729 0
Australia
Date submitted for ethics approval [1] 297729 0
Approval date [1] 297729 0
16/03/2017
Ethics approval number [1] 297729 0
2016-12-884

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
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74958 0
Prof Rodney Daniel Sinclair, MBBS, MD, FACD
Address 74958 0
Sinclair Dermatology
250 Collins Street
East Melbourne, Victoria 3000
Country 74958 0
Australia
Phone 74958 0
+61 3 9654 2426
Fax 74958 0
+61 3 9415 8266
Email 74958 0
[email protected]
Contact person for public queries
Name 74959 0
Deborah Bell
Address 74959 0
Five Corners Pty Ltd
13/76 Reserve Road
Artarmon NSW 2064
Country 74959 0
Australia
Phone 74959 0
+61 2 9460 6688
Fax 74959 0
Email 74959 0
[email protected]
Contact person for scientific queries
Name 74960 0
Rodney Daniel Sinclair, MBBS, MD, FACD
Address 74960 0
Sinclair Dermatology
250 Collins Street
East Melbourne, Victoria 3000
Country 74960 0
Australia
Phone 74960 0
+61 3 9654 2426
Fax 74960 0
+61 3 9415 8266
Email 74960 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No. Data was collected for internal analysis (design validation) and to substantiate safety and efficacy claims for subsequent generations of the device.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.