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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

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]

REV-01

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Androgenetic Alopecia

Condition category

Condition code

Inflammatory and Immune System

Autoimmune diseases

Skin

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]

Treatment: Devices

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Mean Change in Terminal Hair Count from Baseline to 16 Weeks

Timepoint [1]

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.

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

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)

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

Phase 3

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

161

Recruitment in Australia

Recruitment state(s)

NSW,QLD

Recruitment hospital [1]

The Skin Hospital - Darlinghurst

Recruitment hospital [2]

Premier Specialists - Kogarah

Recruitment hospital [3]

Sinclair Dermatology - Sydney

Recruitment hospital [4]

Veracity Clinical Research Pty Ltd - Woolloongabba

Recruitment postcode(s) [1]

2010 - Darlinghurst

Recruitment postcode(s) [2]

2217 - Kogarah

Recruitment postcode(s) [3]

2064 - Sydney

Recruitment postcode(s) [4]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04019795

Register a trial

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