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

NCT05759338 | Completed Results FDA Device

• 1 other identifier: IRB00094234
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the Revian Red All LED cap shows potential to be an effective treatment for Central centrifugal cicatricial alopecia (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. Participants will be asked to use the Revian Red All LED cap once daily for a 10-minute treatment regimen which is the current androgenetic alopecia recommendation.

Conditions

Central Centrifugal Cicatricial Alopecia

Keywords

hair loss; scalp symptoms

Outcome Measures

Primary Outcomes (1)

• Shape of the Hairline Documented With Photographs

  Photographs of the stabilization and regrowth of the hairline documented by standardized camera and dermatoscopic photographs of the scalp

  Baseline to month 6

Secondary Outcomes (2)

• Change in Hairline Assessment Scores by Participant

  Baseline to month 6

• Change in Perifollicular Scale Assessments of Hairline Change by Study Physician

  Baseline to month 6

Study Arms (1)

Intervention

EXPERIMENTAL

Using the Revian Red All LED cap 10 minutes each day for 6 months

Device: Revian Red All LED cap

Interventions

Revian Red All LED cap DEVICE

The cap is a dual-band LED light therapy wireless "smart" cap. It has been shown to be effective in androgenetic alopecia (used once daily, 10-minute treatment regimen) for both men and women.

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: self identified
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who are between the age of eighteen years and sixty-five years
• Biopsy-proven diagnosis of CCCA Stage II-IV.
• 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

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 University Health Sciences, Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Amy McMichael
• Organization: Wake Forest University Health Sciences

Amy.Mcmichael@Advocatehealth.org

704-355-2000

Study Officials

• Amy McMichael, M.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 8, 2023
• Study Start: July 10, 2022
• Primary Completion: June 19, 2024
• Study Completion: June 19, 2024
• Last Updated: August 11, 2025
• Results First Posted: August 11, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)