Clinical Trial 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.
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.