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Completed

NCT Number: NCT05759338

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.

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Key information

Conditions

Central Centrifugal Cicatricial Alopecia Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences, Dermatology

Winston-Salem, North Carolina, 27157, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Shape of the Hairline Documented With Photographs

    Time frame: Baseline to month 6

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

Secondary outcomes

  1. Change in Hairline Assessment Scores by Participant

    Time frame: Baseline to month 6

    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.

  2. Change in Perifollicular Scale Assessments of Hairline Change by Study Physician

    Time frame: Baseline to month 6

    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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 8, 2023
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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