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

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.

Study Overview

• Status: Completed
• Conditions: Central Centrifugal Cicatricial Alopecia
• Intervention / Treatment: Device: Revian Red All LED cap

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).

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences, Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Using the Revian Red All LED cap 10 minutes each day for 6 months	Device: Revian Red All LED cap; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hairline Assessment Scores by Participant	Subjects will complete the standardized questionnaire regarding symptoms of their hair loss: Perception Dermatology Life Quality Index (DLQI) survey - The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.	Baseline to month 6
Change in Perifollicular Scale Assessments of Hairline Change by Study Physician	Scalp and hair exam and assessment with completion of grader survey to measure: Perifollicular scale Mild - affecting <10% of scalp. Moderate - affecting 10-30% of scalp. Severe - affecting >30% of scalp. For all signs other than Vellus/Intermediate/Terminal hair shafts: Percentage of types of hair shafts	Baseline to month 6

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Amy McMichael, M.D., Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2022
• Primary Completion (Actual): June 19, 2024
• Study Completion (Actual): June 19, 2024

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: February 24, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: hair loss; scalp symptoms
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Alopecia Areata; Alopecia
• Other Study ID Numbers: IRB00094234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No