Using a special LED cap to treat a type of hair loss in women
A Pilot Study of Revian Red All LED Cap as a Novel Treatment for Central Centrifugal Cicatricial Alopecia.
This study is testing if a special LED cap can help middle-aged women with a type of hair loss called Central Centrifugal Cicatricial Alopecia by stopping hair loss and possibly encouraging regrowth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT04764331 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effectiveness of the Revian Red All LED cap as a treatment for Central Centrifugal Cicatricial Alopecia (CCCA), a form of scarring hair loss primarily affecting middle-aged women of African descent. The study will enroll five participants who will use the cap daily for 10 minutes over a six-month period. The primary goal is to assess whether the treatment can halt hair loss progression, while secondary outcomes will focus on hair regrowth and symptom relief. Participants will undergo regular assessments, including standardized photos and questionnaires, to monitor their progress.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a biopsy-proven diagnosis of CCCA Stage II-III who have been on stable treatment for at least three months.
Not a fit: Patients with other forms of hair loss or those who have previously undergone light treatment for alopecia will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for women suffering from CCCA, potentially improving hair regrowth and quality of life.
How similar studies have performed: While there is limited research on this specific treatment approach, other studies have explored light therapies for hair loss with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest School of Medicine - Dermatology Clinic — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Amy McMichael, MD — Wake Forest University Health Sciences
- Study coordinator: Irma M Richardson, MHA
- Email: irichard@wakehealth.edu
- Phone: 336-716-2903
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.