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

Central Centrifugal Cicatricial Alopecia (CCCA) Clinical Trial

— CCCA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04207931
• Other study ID #: IRB00043796
• Status: Recruiting
• Phase: Phase 4
• Start date: April 30, 2018
• Est. completion date: November 2024

Study information

• Verified date: January 2024
• Source: Wake Forest University Health Sciences
• Contact: Amy J McMichael, MD
• Phone: 336.716.3926
• Email: amcmichael[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: November 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Central Centrifugal Cicatricial Alopecia (CCCA)

Intervention

Drug:
• Topical steroid class I-II
applied once daily - 18 month duration of the study
• Triamcinolone Acetonide
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.
• Doxycyline
oral antibiotic twice daily for 6 months
• Minoxidil
5% solution or foam started after month 8

Locations

Country	Name	City	State
United States	Wake Forest Baptist Health Department of Dermatology	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	The Skin of Color Society

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline
Primary	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.	Visit 4, Month 6
Secondary	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.	Baseline, Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20
Secondary	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.	Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20
Secondary	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.	Baseline
Secondary	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.	Visit 7, Month 12; Visit 9, Month 18-20