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

Central Centrifugal Cicatricial Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05759338
• Other study ID #: IRB00094234
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2023
• Est. completion date: November 2024

Study information

• Verified date: January 2024
• Source: Wake Forest University Health Sciences
• Contact: Ivie M Obeime, D.O.
• Phone: 336-716-3926
• Email: iobeime[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Central Centrifugal Cicatricial Alopecia

Intervention

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.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences, Dermatology	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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