Wake Forest Baptist Health Department of Dermatology
Winston-Salem, North Carolina, 27157, United States
Location status: Recruiting
NCT Number: NCT04207931
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
Interested in participating?
Request Info18 year–60 year
Female
Interventional
Phase 4
Winston-Salem, North Carolina, 27157, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
applied once daily - 18 month duration of the study
Other names: Clobetasol, Betamethasone Dipropionate, or Fluocinonide
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
oral antibiotic twice daily for 6 months
Other names: Doxy-100, Targadox, Oracea
5% solution or foam started after month 8
Other names: Rogaine
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Amy J McMichael, MD
CONTACT
Judy Holbrook, CRC
CONTACT
Wake Forest University Health Sciences
Other
Acronym: CCCA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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