A Pilot Study of Revian Red All LED Cap as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
Primary Purpose
Central Centrifugal Cicatricial Alopecia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Revian Red All LED cap
Sponsored by
About this trial
This is an interventional treatment trial for Central Centrifugal Cicatricial Alopecia
Eligibility Criteria
Inclusion Criteria:
- Women who are eighteen years of age or older with a biopsy-proven diagnosis of CCCA Stage II-III. They also must be on stable treatment without changes (on doxycycline, topical steroids, minoxidil and/or post 8 rounds of intralesional steroids) for at least 3 months.
- Subjects will be recruited from outpatient dermatology clinics at the Wake Forest Baptist Health Department of Dermatology.
Exclusion Criteria
- Subjects with other forms of hair loss that is not CCCA
- Prior treatment with light source for alopecia
- Males are excluded from this study since the prevalence of CCCA in males is so significantly low that it is difficult to find cases in a clinical setting
Sites / Locations
- Wake Forest School of Medicine - Dermatology ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention
Arm Description
Caps will be provided for each subjects will use the cap once daily for10-minute treatment regimen
Outcomes
Primary Outcome Measures
hairline stabilization
Pre treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth
hairline stabilization
Post-treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth
hairline stabilization
Post-treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth
hairline regrowth
Pre treatment photographs will be assessed to determine if further scalp hairline recession is present and to look for hair regrowth
hairline regrowth
Post-treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth
hairline regrowth
Post-treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth
Secondary Outcome Measures
patient assessment of stabilization
Questionnaire will be completed at baseline
patient assessment of stabilization
Questionnaire will be completed at end of study
Full Information
NCT ID
NCT04764331
First Posted
February 18, 2021
Last Updated
June 29, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04764331
Brief Title
A Pilot Study of Revian Red All LED Cap as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
Official Title
A Pilot Study of Revian Red All LED Cap as a Novel Treatment for Central Centrifugal Cicatricial Alopecia.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Central centrifugal cicatricial alopecia (CCCA) is form of scarring hair loss that predominately affects middle-aged women of African descent.1 . 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 tenderness.2
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 discouraged.3 Many commonly used therapies are anti-inflammatory in nature, including intralesional steroids, topical steroids, oral antibiotics and increased frequency of hair washing with antidandruff shampoos.4 These treatments not only lead to improvement in pruritus and tenderness, but in some cases result in increased hair density.5 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Centrifugal Cicatricial Alopecia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Other
Arm Description
Caps will be provided for each subjects will use the cap once daily for10-minute treatment regimen
Intervention Type
Device
Intervention Name(s)
Revian Red All LED cap
Other Intervention Name(s)
Revian Red
Intervention Description
Cap that uses two wavelengths of light, 620 nm and 660 nm will be used once a day for 10 minutes.for treatment
Primary Outcome Measure Information:
Title
hairline stabilization
Description
Pre treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth
Time Frame
Change from baseline to month 2
Title
hairline stabilization
Description
Post-treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth
Time Frame
Change from month 2 to month 4
Title
hairline stabilization
Description
Post-treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth
Time Frame
Change from month 4 to month 6 (end of study)
Title
hairline regrowth
Description
Pre treatment photographs will be assessed to determine if further scalp hairline recession is present and to look for hair regrowth
Time Frame
Change from baseline to month 2
Title
hairline regrowth
Description
Post-treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth
Time Frame
Change from month 2 to month 4
Title
hairline regrowth
Description
Post-treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth
Time Frame
Change from month 4 to month 6 (end of study)
Secondary Outcome Measure Information:
Title
patient assessment of stabilization
Description
Questionnaire will be completed at baseline
Time Frame
baseline
Title
patient assessment of stabilization
Description
Questionnaire will be completed at end of study
Time Frame
month 6
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women who are eighteen years of age or older with a biopsy-proven diagnosis of CCCA Stage II-III. They also must be on stable treatment without changes (on doxycycline, topical steroids, minoxidil and/or post 8 rounds of intralesional steroids) for at least 3 months.
Subjects will be recruited from outpatient dermatology clinics at the Wake Forest Baptist Health Department of Dermatology.
Exclusion Criteria
Subjects with other forms of hair loss that is not CCCA
Prior treatment with light source for alopecia
Males are excluded from this study since the prevalence of CCCA in males is so significantly low that it is difficult to find cases in a clinical setting
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irma M Richardson, MHA
Phone
336-716-2903
Email
irichard@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy McMichael, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest School of Medicine - Dermatology Clinic
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany Feaster
Phone
336-407-5731
Email
bfeaster@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Irma M Richardon, MHA
Phone
336-716-2903
Email
irichard@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Amy McMichael, MD
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of Revian Red All LED Cap as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
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