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

Primary Purpose

Central Centrifugal Cicatricial Alopecia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Revian Red All LED cap
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Centrifugal Cicatricial Alopecia focused on measuring hair loss, scalp symptoms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Health Sciences, DermatologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Using the Revian Red All LED cap 10 minutes each day for 6 months

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

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.
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
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
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
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
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
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
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

Full Information

First Posted
February 24, 2023
Last Updated
August 28, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05759338
Brief Title
A Study of Revian Red All LED Cap as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
Official Title
A Study of Revian Red All LED Cap as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Centrifugal Cicatricial Alopecia
Keywords
hair loss, scalp symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Using the Revian Red All LED cap 10 minutes each day for 6 months
Intervention Type
Device
Intervention Name(s)
Revian Red All LED cap
Intervention Description
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 Outcome Measure Information:
Title
Shape of the hairline documented with photographs
Description
Photographs of the stabilization and regrowth of the hairline documented by standardized camera and dermatoscopic photographs of the scalp
Time Frame
Baseline
Title
Shape of the hairline documented with photographs
Description
Photographs of the stabilization and regrowth of the hairline documented by standardized camera and dermatoscopic photographs of the scalp
Time Frame
month 2
Title
Shape of the hairline documented with photographs
Description
Photographs of the stabilization and regrowth of the hairline documented by standardized camera and dermatoscopic photographs of the scalp
Time Frame
month 4
Title
Shape of the hairline documented with photographs
Description
Photographs of the stabilization and regrowth of the hairline documented by standardized camera and dermatoscopic photographs of the scalp
Time Frame
month 6
Secondary Outcome Measure Information:
Title
Change in hairline assessment scores by participant
Description
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.
Time Frame
Baseline and month 6
Title
Change in Perifollicular scale Assessments of hairline change by study physician
Description
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
Time Frame
Baseline, month 2, month 4, month 6
Title
Change in Hyperpigmentation Assessments of hairline change by study physician
Description
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
Time Frame
Baseline, month 2, month 4, month 6
Title
Change in Breakage Assessments of hairline change by study physician
Description
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
Time Frame
Baseline, month 2, month 4, month 6
Title
Change in Interfollicular scale Assessments of hairline change by study physician
Description
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
Time Frame
Baseline, month 2, month 4, month 6
Title
Change in Erythema Assessments of hairline change by study physician
Description
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
Time Frame
Baseline, month 2, month 4, month 6
Title
Change in Loss of follicular openings Assessments of hairline change by study physician
Description
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
Time Frame
Baseline, month 2, month 4, month 6
Title
Change in Vellus/Intermediate/Terminal hair shafts Assessments of hairline change by study physician
Description
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
Time Frame
Baseline, month 2, month 4, month 6

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
self identified
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ivie M Obeime, D.O.
Phone
336-716-3926
Email
iobeime@wakehealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Irma M Richardson, MHA
Phone
336-716-2903
Email
irichard@wakhealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy McMichael, M.D.
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences, Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivie M Obeime, D.O.
Phone
336-716-3926
Email
iobeime@wakehealth.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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