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

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

Study Overview

• Status: Recruiting
• Conditions: Central Centrifugal Cicatricial Alopecia (CCCA)
• Intervention / Treatment: Drug: Topical steroid class I-II; Drug: Doxycyline; Drug: Minoxidil; Drug: Triamcinolone Acetonide

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Amy J McMichael, MD; Phone Number: 336.716.3926; Email: amcmichael@wakehealth.edu
• Study Contact Backup: Name: Judy Holbrook, CRC; Phone Number: 336.716.8991; Email: jholbroo@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest Baptist Health Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Topical steroid plus oral antibiotic group; 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.	Drug: Topical steroid class I-II; applied once daily - 18 month duration of the study; Other Names: Clobetasol, Betamethasone Dipropionate, or Fluocinonide; Drug: Doxycyline; oral antibiotic twice daily for 6 months; Other Names: Oracea; Doxy-100; Targadox; Drug: Minoxidil; 5% solution or foam started after month 8; Other Names: Rogaine
Active Comparator: Topical steroid plus intralesional steroid injection group; 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	Drug: Topical steroid class I-II; applied once daily - 18 month duration of the study; Other Names: Clobetasol, Betamethasone Dipropionate, or Fluocinonide; Drug: Minoxidil; 5% solution or foam started after month 8; Other Names: Rogaine; Drug: 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.; Other Names: Kenaolog

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: The Skin of Color Society
• Investigators: Principal Investigator: Amy J McMichael, MD, Wake Forest Baptist Health Department of Dermatology

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2018
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: alopecia; Minoxidil; Hair loss; Female hair loss; Topical Steroid
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Clobetasol; Minoxidil; Fluocinonide
• Other Study ID Numbers: IRB00043796

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No