Clinical trial NCT05759338: A Study of Revian Red All LED Cap as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
Official title: A Study of Revian Red All LED Cap as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Centrifugal Cicatricial Alopecia
Keywords: hair loss
scalp symptoms
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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. A study cap will be provided for each subject. Subjects will use the cap once daily, 10-minute treatment regimen which is the current androgenetic alopecia recommendation. The subjects will use the cap for a total of 6 months. To use the cap, subjects will connect the Revian Red All LED cap to a Smart App on a mobile phone device using Bluetooth. Subjects can use the Smart App to set daily reminders to use the cap, track and log usage, and use the 10 minute timer. No additional information will be stored on the Smart App. Only subjects will have access to the Smart App located on their personal mobile phone device.

Standardized photos and trichoscopic photos before starting treatment and every 2 months for x 6 total months will be taken to assess hairline stabilization and potential for regrowth. A baseline photo and completion photo will also be taken with a visio device. This will help determine pigmentation of the present hairs throughout the study.

Prior to study enrollment, all participants will receive a detailed explanation of the purpose of the study and will undergo written informed consent. Clinical history of hair loss and history of prior treatment will be obtained by administering a standardized questionnaire to all subjects. Subjects will also fill out a questionnaire regarding symptoms of their hair loss at each visit. There will be 4 visits total (1 Pre-treatment visit and 3 Follow up visits).

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

Primary outcomes:
measure: Shape of the hairline documented with photographs
timeFrame: Baseline
measure: Shape of the hairline documented with photographs
timeFrame: month 2
measure: Shape of the hairline documented with photographs
timeFrame: month 4
measure: Shape of the hairline documented with photographs
timeFrame: month 6
Secondary outcomes:
measure: Change in hairline assessment scores by participant
timeFrame: Baseline and month 6
measure: Change in Perifollicular scale Assessments of hairline change by study physician
timeFrame: Baseline, month 2, month 4, month 6
measure: Change in Hyperpigmentation Assessments of hairline change by study physician
timeFrame: Baseline, month 2, month 4, month 6
measure: Change in Breakage Assessments of hairline change by study physician
timeFrame: Baseline, month 2, month 4, month 6
measure: Change in Interfollicular scale Assessments of hairline change by study physician
timeFrame: Baseline, month 2, month 4, month 6
measure: Change in Erythema Assessments of hairline change by study physician
timeFrame: Baseline, month 2, month 4, month 6
measure: Change in Loss of follicular openings Assessments of hairline change by study physician
timeFrame: Baseline, month 2, month 4, month 6
measure: Change in Vellus/Intermediate/Terminal hair shafts Assessments of hairline change by study physician
timeFrame: Baseline, month 2, month 4, month 6
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences, Dermatology
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Amy McMichael, M.D.
role: PRINCIPAL_INVESTIGATOR
References: