N/A
N=24
A Study of Revian Red All LED Cap as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
Central Centrifugal Cicatricial Alopecia
Bottom Line
View on ClinicalTrials.gov: NCT05759338 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Shape of the Hairline Documented With Photographs — 8; 12; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Revian Red All LED cap (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Shape of the Hairline Documented With Photographs |
8; 12; 2 | — |
| SECONDARY Change in Hairline Assessment Scores by Participant |
11; 6; 4 | — |
| SECONDARY Change in Perifollicular Scale Assessments of Hairline Change by Study Physician |
13; 6; 13; 8; 1; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
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
Data sourced from ClinicalTrials.gov (NCT05759338). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.