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Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study (CCCA)

Primary Purpose

Central Centrifugal Cicatricial Alopecia (CCCA)

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Topical steroid class I-II
Triamcinolone Acetonide
Doxycyline
Minoxidil
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 (CCCA) focused on measuring alopecia, Hair loss, Female hair loss, Minoxidil, Topical Steroid

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • African-American women, ages 18-60 years old
  • with a clinical diagnosis and biopsy-proven CCCA, with Central Scalp Alopecia Scale severity 1 through 4 will be included in this study
  • These subjects will be seen and treated in Wake Forest Baptist Health Dermatology Outpatient Clinic

Exclusion Criteria:

  • Patients with other forms of hair loss in addition to CCCA will be excluded
  • Other patients to be excluded are those with other forms of inflammatory scalp disease (with the exception of mild seborrheic dermatitis)
  • patients who have had topical treatment for CCCA within the past 4 months (including topical steroids, topical minoxidil, or any other topical hair regrowth medication)
  • patients who have been on a long-term oral antibiotics for hair loss within the past year
  • patients who have undergone more than two rounds of intralesional steroid injections to the scalp in the past one year.

Sites / Locations

  • Wake Forest Baptist Health Department of DermatologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Topical steroid plus oral antibiotic group

Topical steroid plus intralesional steroid injection group

Arm Description

Participants in this group receive topical steroid (class I-II applied once daily) plus oral antibiotic group (doxycyline 100 mg twice daily for 6 months), and then topical minoxidil (5% solution or foam) after 8 months of treatment.

Participants in this group receive topical steroid (class I-II applied once daily) plus intralesional steroid group (7.5mg/cc of kenaolog, max dose of 3 cc), and then topical minoxidil (5% solution or foam) after 8 months of treatment

Outcomes

Primary Outcome Measures

Central Scalp Alopecia Photographic Scale in African American Women
Photographs of the subject's scalp will be taken at baseline. This instrument is a 6-point scale that includes gradations in hair loss from normal (0) to bald scalp (5). Higher numbers denote greater hair loss.
Central Scalp Alopecia Photographic Scale in African American Women
This instrument is a 6-point scale that includes gradations in hair loss from normal (0) to bald scalp (5). Higher numbers denote greater hair loss.

Secondary Outcome Measures

Hair Loss Questionnaire
Questionnaire gathers the epidemiologic data about the patient's hair loss, family history of hair loss, what treatments have been tried in the past, and hair care practices. There is no range and/or direction as this questionnaire is used to gather descriptive data.
Dermatology Life Quality Index (DLQI)
Questionnaire measures how CCCA and the symptoms associated have affected daily activities over the past week. A 5-point scale is used. It ranges from 'Very Much' to 'Not Relevant' with 'Very Much' meaning that it negatively affects their daily living and quality of life and 'Not Relevant' meaning that it has no effect on their daily living and quality of life.
Last Year Dermatology Life Quality Index (LYDLQI)
Questionnaire measures how CCCA and the symptoms associated have affected daily activities over the past year. A 5-point scale is used. It ranges from 'Very Much' to 'Not Relevant' with 'Very Much' meaning that it negatively affects their daily living and quality of life and 'Not Relevant' meaning that it has no effect on their daily living and quality of life.
Central Scalp Alopecia Photographic Scale in African American Women
This instrument is a 6-point scale that includes gradations in hair loss from normal (0) to bald scalp (5). Higher numbers denote greater hair loss.

Full Information

First Posted
December 19, 2019
Last Updated
June 29, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
The Skin of Color Society
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1. Study Identification

Unique Protocol Identification Number
NCT04207931
Brief Title
Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study
Acronym
CCCA
Official Title
Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2018 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
The Skin of Color Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to examine photos of CCCA patients taken before and after treatment to compare treatment outcomes between different treatment groups
Detailed Description
Treatment groups that patients will be randomized to include 1) topical steroid plus oral antibiotic group, and topical minoxidil after 8 months 2) topical steroid plus intralesional steroid group and topical minoxidil after 8 months. Both these regimens are used as the first-line treatments by clinicians. The objective of this study is to examine photos of CCCA patients taken before and after treatment to compare treatment outcomes between different treatment groups. In this study, the investigators are looking to determine how standard treatment affects the outcome of central centrifugal cicatricial alopecia; to determine if topical steroid with With Doxycycline has better outcome than topical steroids with intralesional steroids in central centrifugal cicatricial alopecia, and to determine how the addition of topical minoxidil as a treatment changes the outcome of central centrifugal cicatricial alopecia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Centrifugal Cicatricial Alopecia (CCCA)
Keywords
alopecia, Hair loss, Female hair loss, Minoxidil, Topical Steroid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Treatment groups that patients will be randomized to include 1) topical steroid plus oral antibiotic group, and topical minoxidil after 8 months 2) topical steroid plus intralesional steroid group and topical minoxidil after 8 months.
Masking
Outcomes Assessor
Masking Description
To help ensure subject privacy and confidentiality, only a unique study identifier will appear on the data collection form. The data collected will be stored on the Research Electronic Database CaptureTM with access limited to designated study personnel. Blinded investigators from Wake Forest Baptist Department of Dermatology will later review photographs of each subject taken at baseline and at month 18 and will assign severity scores to the photographs based on the Central Scalp Alopecia Scale. These investigators will not know when each photograph was taken.
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Topical steroid plus oral antibiotic group
Arm Type
Active Comparator
Arm Description
Participants in this group receive topical steroid (class I-II applied once daily) plus oral antibiotic group (doxycyline 100 mg twice daily for 6 months), and then topical minoxidil (5% solution or foam) after 8 months of treatment.
Arm Title
Topical steroid plus intralesional steroid injection group
Arm Type
Active Comparator
Arm Description
Participants in this group receive topical steroid (class I-II applied once daily) plus intralesional steroid group (7.5mg/cc of kenaolog, max dose of 3 cc), and then topical minoxidil (5% solution or foam) after 8 months of treatment
Intervention Type
Drug
Intervention Name(s)
Topical steroid class I-II
Other Intervention Name(s)
Clobetasol, Betamethasone Dipropionate, or Fluocinonide
Intervention Description
applied once daily - 18 month duration of the study
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Other Intervention Name(s)
Kenaolog
Intervention Description
Intralesional Steroid Injection, 7.5mg/cc. max dose of 3 cc. Scalp injections will be administered every 6-8 weeks, for a total of 8 injections.
Intervention Type
Drug
Intervention Name(s)
Doxycyline
Other Intervention Name(s)
Doxy-100, Targadox, Oracea
Intervention Description
oral antibiotic twice daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Minoxidil
Other Intervention Name(s)
Rogaine
Intervention Description
5% solution or foam started after month 8
Primary Outcome Measure Information:
Title
Central Scalp Alopecia Photographic Scale in African American Women
Description
Photographs of the subject's scalp will be taken at baseline. This instrument is a 6-point scale that includes gradations in hair loss from normal (0) to bald scalp (5). Higher numbers denote greater hair loss.
Time Frame
baseline
Title
Central Scalp Alopecia Photographic Scale in African American Women
Description
This instrument is a 6-point scale that includes gradations in hair loss from normal (0) to bald scalp (5). Higher numbers denote greater hair loss.
Time Frame
Visit 4, Month 6
Secondary Outcome Measure Information:
Title
Hair Loss Questionnaire
Description
Questionnaire gathers the epidemiologic data about the patient's hair loss, family history of hair loss, what treatments have been tried in the past, and hair care practices. There is no range and/or direction as this questionnaire is used to gather descriptive data.
Time Frame
Baseline, Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20
Title
Dermatology Life Quality Index (DLQI)
Description
Questionnaire measures how CCCA and the symptoms associated have affected daily activities over the past week. A 5-point scale is used. It ranges from 'Very Much' to 'Not Relevant' with 'Very Much' meaning that it negatively affects their daily living and quality of life and 'Not Relevant' meaning that it has no effect on their daily living and quality of life.
Time Frame
Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20
Title
Last Year Dermatology Life Quality Index (LYDLQI)
Description
Questionnaire measures how CCCA and the symptoms associated have affected daily activities over the past year. A 5-point scale is used. It ranges from 'Very Much' to 'Not Relevant' with 'Very Much' meaning that it negatively affects their daily living and quality of life and 'Not Relevant' meaning that it has no effect on their daily living and quality of life.
Time Frame
Baseline
Title
Central Scalp Alopecia Photographic Scale in African American Women
Description
This instrument is a 6-point scale that includes gradations in hair loss from normal (0) to bald scalp (5). Higher numbers denote greater hair loss.
Time Frame
Visit 7, Month 12; Visit 9, Month 18-20

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
African-American women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: African-American women, ages 18-60 years old with a clinical diagnosis and biopsy-proven CCCA, with Central Scalp Alopecia Scale severity 1 through 4 will be included in this study These subjects will be seen and treated in Wake Forest Baptist Health Dermatology Outpatient Clinic Exclusion Criteria: Patients with other forms of hair loss in addition to CCCA will be excluded Other patients to be excluded are those with other forms of inflammatory scalp disease (with the exception of mild seborrheic dermatitis) patients who have had topical treatment for CCCA within the past 4 months (including topical steroids, topical minoxidil, or any other topical hair regrowth medication) patients who have been on a long-term oral antibiotics for hair loss within the past year patients who have undergone more than two rounds of intralesional steroid injections to the scalp in the past one year.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy J McMichael, MD
Phone
336.716.3926
Email
amcmichael@wakehealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Judy Holbrook, CRC
Phone
336.716.8991
Email
jholbroo@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy J McMichael, MD
Organizational Affiliation
Wake Forest Baptist Health Department of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Health Department of Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
1739290
Citation
Sperling LC, Sau P. The follicular degeneration syndrome in black patients. 'Hot comb alopecia' revisited and revised. Arch Dermatol. 1992 Jan;128(1):68-74.
Results Reference
background
PubMed Identifier
22092575
Citation
Bin Saif GA, Ericson ME, Yosipovitch G. The itchy scalp--scratching for an explanation. Exp Dermatol. 2011 Dec;20(12):959-68. doi: 10.1111/j.1600-0625.2011.01389.x.
Results Reference
background

Learn more about this trial

Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study

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