Ignite Creation Date:
2024-05-06 @ 1:24 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04019795
Status:
COMPLETED
Last Update Posted:
2019-07-15
First Post:
2019-07-11
Brief Title:
Modulated Light Therapy in Participants With Pattern Hair Loss
Sponsor:
PhotonMD Inc
Organization:
PhotonMD Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REV-01
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None