Recruiting

Revian Red

Sponsor:

Wake Forest University Health Sciences

Code:

NCT04764331

Conditions

Central Centrifugal Cicatricial Alopecia

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Revian Red All LED cap

Study Details

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.

Conditions

Central Centrifugal Cicatricial Alopecia

Study ID

NCT04764331

Start date

Jul 6, 2021

Status verified date

Mar, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Intervention

Caps will be provided for each subjects will use the cap once daily for10-minute treatment regimen

Interventions

Revian Red All LED cap

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

  • hairline stabilization [ Time Frame: Change from baseline to month 2 ]
  • hairline stabilization [ Time Frame: Change from month 2 to month 4 ]
  • hairline stabilization [ Time Frame: Change from month 4 to month 6 (end of study) ]
  • hairline regrowth [ Time Frame: Change from baseline to month 2 ]
  • hairline regrowth [ Time Frame: Change from month 2 to month 4 ]
  • hairline regrowth [ Time Frame: Change from month 4 to month 6 (end of study) ]

Central Contacts and Locations

Central contacts

Locations

Wake Forest School of Medicine - Dermatology Clinic

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Principal Investigator:

Amy McMichael, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-03-04.