Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04207931
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : December 23, 2019
Sponsor:
Collaborator:
The Skin of Color Society
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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

Condition or disease Intervention/treatment Phase
Central Centrifugal Cicatricial Alopecia (CCCA) Drug: Topical steroid class I-II Drug: Triamcinolone Acetonide Drug: Doxycyline Drug: Minoxidil Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (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.

Primary Purpose: Treatment
Official Title: Treatment Results for Patients With Central Centrifugal Cicatricial Alopecia (CCCA): a Multicenter Prospective Study
Actual Study Start Date : April 30, 2018
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021


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 Name: Clobetasol, Betamethasone Dipropionate, or Fluocinonide

Drug: Doxycyline
oral antibiotic twice daily for 6 months
Other Names:
  • Doxy-100
  • Targadox
  • Oracea

Drug: Minoxidil
5% solution or foam started after month 8
Other Name: 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 Name: Clobetasol, Betamethasone Dipropionate, or Fluocinonide

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 Name: Kenaolog

Drug: Minoxidil
5% solution or foam started after month 8
Other Name: Rogaine




Primary Outcome Measures :
  1. Central Scalp Alopecia Photographic Scale in African American Women [ Time Frame: baseline ]
    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.

  2. Central Scalp Alopecia Photographic Scale in African American Women [ Time Frame: Visit 4, Month 6 ]
    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 :
  1. Hair Loss Questionnaire [ Time Frame: Baseline, Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20 ]

    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.


  2. Dermatology Life Quality Index (DLQI) [ Time Frame: Visit 4, Month 6; Visit 7, Month 12; and Visit 9, Month 18-20 ]
    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.

  3. Last Year Dermatology Life Quality Index (LYDLQI) [ Time Frame: Baseline ]
    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.

  4. Central Scalp Alopecia Photographic Scale in African American Women [ Time Frame: Visit 7, Month 12; Visit 9, Month 18-20 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   African-American women
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04207931


Contacts
Layout table for location contacts
Contact: Amy J McMichael, MD 336.716.3926 amcmichael@wakehealth.edu
Contact: Gina Barker, CRC 336.713.4116 gbarker@wakehealth.edu

Locations
Layout table for location information
United States, North Carolina
Wake Forest Baptist Health Department of Dermatology Recruiting
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
The Skin of Color Society
Investigators
Layout table for investigator information
Principal Investigator: Amy J McMichael, MD Wake Forest Baptist Health Department of Dermatology
Publications:
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04207931    
Other Study ID Numbers: IRB00043796
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
alopecia
Hair loss
Female hair loss
Minoxidil
Topical Steroid
Additional relevant MeSH terms:
Layout table for MeSH terms
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Fluocinonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Clobetasol
Minoxidil
Betamethasone sodium phosphate
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Asthmatic Agents
Respiratory System Agents
Antihypertensive Agents