A Pilot Study of Revian Red All LED Cap as a Novel Treatment for Central Centrifugal Cicatricial Alopecia

NCT04764331 | Recruiting FDA Device

• 1 other identifier: IRB00071484
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• hairline stabilization

  Pre treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth

  Change from baseline to month 2

• hairline stabilization

  Post-treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth

  Change from month 2 to month 4

• hairline stabilization

  Post-treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth

  Change from month 4 to month 6 (end of study)

• hairline regrowth

  Pre treatment photographs will be assessed to determine if further scalp hairline recession is present and to look for hair regrowth

  Change from baseline to month 2

• hairline regrowth

  Post-treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth

  Change from month 2 to month 4

• hairline regrowth

  Post-treatment photographs will also be assessed to determine if further scalp hairline recession is present and to look for hair regrowth

  Change from month 4 to month 6 (end of study)

Secondary Outcomes (2)

• patient assessment of stabilization

  baseline

• patient assessment of stabilization

  month 6

Study Arms (1)

Intervention

OTHER

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

Device: Revian Red All LED cap

Interventions

Revian Red All LED cap DEVICE

Cap that uses two wavelengths of light, 620 nm and 660 nm will be used once a day for 10 minutes.for treatment

Also known as: Revian Red

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest School of Medicine - Dermatology Clinic

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Study Officials

• Amy McMichael, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irma M Richardson, MHA

CONTACT

336-716-2903; irichard@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: July 6, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (1)