Ignite Creation Date:
2024-05-06 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05759338
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-02-24
Brief Title:
A Study of Revian Red All LED Cap as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
A Study of Revian Red All LED Cap as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
The purpose of this study is to determine if the Revian Red All LED cap shows potential to be an effective treatment for Central centrifugal cicatricial alopecia CCCA by recruiting hair follicles back to anagen growth or by improving inflammation The primary outcome is to determine if hair loss regression is halted Secondary outcomes include hair regrowth and alleviation of signs and symptoms of the disease
Participants will be asked to use the Revian Red All LED cap once daily for a 10-minute treatment regimen which is the current androgenetic alopecia recommendation
Participants will be asked to use the Revian Red All LED cap once daily for a 10-minute treatment regimen which is the current androgenetic alopecia recommendation
Detailed Description:
Subjects who are willing to participate in a novel treatment for Revian Red All LED cap will be enrolled in this study The cap uses two wavelengths of light 620 nm and 660 nm A study cap will be provided for each subject Subjects will use the cap once daily 10-minute treatment regimen which is the current androgenetic alopecia recommendation The subjects will use the cap for a total of 6 months To use the cap subjects will connect the Revian Red All LED cap to a Smart App on a mobile phone device using Bluetooth Subjects can use the Smart App to set daily reminders to use the cap track and log usage and use the 10 minute timer No additional information will be stored on the Smart App Only subjects will have access to the Smart App located on their personal mobile phone device
Standardized photos and trichoscopic photos before starting treatment and every 2 months for x 6 total months will be taken to assess hairline stabilization and potential for regrowth A baseline photo and completion photo will also be taken with a visio device This will help determine pigmentation of the present hairs throughout the study
Prior to study enrollment all participants will receive a detailed explanation of the purpose of the study and will undergo written informed consent Clinical history of hair loss and history of prior treatment will be obtained by administering a standardized questionnaire to all subjects Subjects will also fill out a questionnaire regarding symptoms of their hair loss at each visit There will be 4 visits total 1 Pre-treatment visit and 3 Follow up visits
Standardized photos and trichoscopic photos before starting treatment and every 2 months for x 6 total months will be taken to assess hairline stabilization and potential for regrowth A baseline photo and completion photo will also be taken with a visio device This will help determine pigmentation of the present hairs throughout the study
Prior to study enrollment all participants will receive a detailed explanation of the purpose of the study and will undergo written informed consent Clinical history of hair loss and history of prior treatment will be obtained by administering a standardized questionnaire to all subjects Subjects will also fill out a questionnaire regarding symptoms of their hair loss at each visit There will be 4 visits total 1 Pre-treatment visit and 3 Follow up visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None