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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Central Centrifugal Cicatricial Alopecia

Intervention / Treatment
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* Device: Revian Red All LED cap


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Using the Revian Red All LED cap 10 minutes each day for 6 months | Device: Revian Red All LED cap<br>* 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.<br>|

What is the study measuring?
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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 | 
| 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 | month 2 | 
| 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 | month 4 | 
| 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 | 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 and 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, month 2, month 4, month 6 | 
| Change in Hyperpigmentation Assessments of hairline change by study physician | Scalp and hair exam and assessment with completion of grader survey to measure: Hyperpigmentation 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, month 2, month 4, month 6 | 
| Change in Breakage Assessments of hairline change by study physician | Scalp and hair exam and assessment with completion of grader survey to measure: Breakage 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, month 2, month 4, month 6 | 
| Change in Interfollicular scale Assessments of hairline change by study physician | Scalp and hair exam and assessment with completion of grader survey to measure: Interfollicular 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, month 2, month 4, month 6 | 
| Change in Erythema Assessments of hairline change by study physician | Scalp and hair exam and assessment with completion of grader survey to measure: Erythema 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, month 2, month 4, month 6 | 
| Change in Loss of follicular openings Assessments of hairline change by study physician | Scalp and hair exam and assessment with completion of grader survey to measure: Loss of follicular openings 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, month 2, month 4, month 6 | 
| Change in Vellus/Intermediate/Terminal hair shafts Assessments of hairline change by study physician | Scalp and hair exam and assessment with completion of grader survey to measure: Vellus/Intermediate/Terminal hair shafts 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, month 2, month 4, month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hair loss, scalp symptoms