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
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest University Health Sciences, Dermatology | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
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 |
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