Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04764331
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2021-02-18
Brief Title:
A Pilot 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 Pilot Study of Revian Red All LED Cap as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Central centrifugal cicatricial alopecia CCCA is form of scarring hair loss that predominately affects middle-aged women of African descent1 Clinically the natural progression of CCCA starts at the crown as roughly circular scarred patches which evolve into scarred areas increasing in size circumferentially Characteristically the scar is often smooth and shiny and the hair density in the affected area is frequently decreased The hair remaining in the scarred areas is more brittle and shorter than the hair in unaffected areas Since CCCA is a scarring disorder it can cause permanent hair loss dyesthesias and psychological distress which can affect overall quality of life Affected individuals may complain of pruritus pain or tenderness2
The management of CCCA is challenging due to limited current treatments and a lack of randomized controlled trails Management focuses on behavioral and styling modifications in addition to symptomatic relief Any potentially damaging hair care practices such as chemical relaxers heat application to the scalp and the use of hardening gels and sprays are discouraged3 Many commonly used therapies are anti-inflammatory in nature including intralesional steroids topical steroids oral antibiotics and increased frequency of hair washing with antidandruff shampoos4 These treatments not only lead to improvement in pruritus and tenderness but in some cases result in increased hair density5 Since there is limited investigation done to determine the most effective treatment approach for CCCA subjects it would be of great benefit to determine if there is any advantage in using one particular anti-inflammatory therapy over others and whether one is more efficacious in relieving symptoms or promoting hair regrowth in follicles that have not yet become scarred
The Revian Red All LED cap is a dual-band LED light therapy wireless smart cap It has been effective in androgenetic alopecia used once daily 10-minute treatment regimen for both men and women There are also reportedly minimal side effects unlike with topical minoxidil which can cause pruritus and initial hair shedding in the first few weeks or finasteride which can cause gynecomastia and loss of libido In this study we hope to see if the anti-inflammatory capabilities of this cap can improve scalp symptoms reduce hair loss and promote maturation of vellus and intermediate hairs in non-scarred areas of the scalp in those affected by CCCA
The management of CCCA is challenging due to limited current treatments and a lack of randomized controlled trails Management focuses on behavioral and styling modifications in addition to symptomatic relief Any potentially damaging hair care practices such as chemical relaxers heat application to the scalp and the use of hardening gels and sprays are discouraged3 Many commonly used therapies are anti-inflammatory in nature including intralesional steroids topical steroids oral antibiotics and increased frequency of hair washing with antidandruff shampoos4 These treatments not only lead to improvement in pruritus and tenderness but in some cases result in increased hair density5 Since there is limited investigation done to determine the most effective treatment approach for CCCA subjects it would be of great benefit to determine if there is any advantage in using one particular anti-inflammatory therapy over others and whether one is more efficacious in relieving symptoms or promoting hair regrowth in follicles that have not yet become scarred
The Revian Red All LED cap is a dual-band LED light therapy wireless smart cap It has been effective in androgenetic alopecia used once daily 10-minute treatment regimen for both men and women There are also reportedly minimal side effects unlike with topical minoxidil which can cause pruritus and initial hair shedding in the first few weeks or finasteride which can cause gynecomastia and loss of libido In this study we hope to see if the anti-inflammatory capabilities of this cap can improve scalp symptoms reduce hair loss and promote maturation of vellus and intermediate hairs in non-scarred areas of the scalp in those affected by CCCA
Detailed Description:
The purpose of this pilot study is to determine if the Revian Red All LED cap shows potential to be an effective treatment for 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
Methods and Measures
Design 5 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 caps 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
Standardized photos and dermatoscope photos before starting treatment and every 2 months for x 6 total months will be taken to assess hairline stabilization and potential for regrowth
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 subsequent treatment visit and at follow-up In order to be eligible subjects must be diagnosed clinically and histologically with CCCA Diagnosis will be made only by a board-certified dermatologist
Methods and Measures
Design 5 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 caps 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
Standardized photos and dermatoscope photos before starting treatment and every 2 months for x 6 total months will be taken to assess hairline stabilization and potential for regrowth
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 subsequent treatment visit and at follow-up In order to be eligible subjects must be diagnosed clinically and histologically with CCCA Diagnosis will be made only by a board-certified dermatologist
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