Apremilast in the Treatment of Central Centrifugal Cicatricial Alopecia (CCCA) (NCT03521687) | Clinical Trial Compass
CompletedPhase 4
Apremilast in the Treatment of Central Centrifugal Cicatricial Alopecia (CCCA)
United States20 participantsStarted 2018-11-15
Plain-language summary
This is a single-center, open-label clinical study to study the efficacy of apremilast in the treatment of mild to moderate central centrifugal cicatricial alopecia. The investigators hypothesize that the anti-inflammatory properties of apremilast may play a role in the decreasing scalp inflammation in patients with CCCA and may prevent further hair loss and potentially induce hair regrowth in patients with mild to moderate disease.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Provide written, signed and dated informed consent prior to initiating any study-related activities
* Females of African ancestry \>18 years of age at the time of screening
* Clinical diagnosis of mild to moderate vertex-predominant CCCA as defined by CHLG stages 1B, 2B, 3B
* Punch biopsy at screening, or punch biopsy of the scalp within six months prior to screening visit, consistent with CCCA
* Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options.
* Must be in general good health as judged by the Investigator, based on medical history and physical examination. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
Exclusion Criteria:
* Systemic or intralesional treatment of CCCA for 4 weeks prior to baseline visit, including but not limited to corticosteroids (systemic, intralesional), oral tetracycline antibiotics, and oral anti-inflammatory medications
* Topical corticosteroid or calcineurin inhibitor treatment of CCCA for 2 weeks prior to baseline visit.
* Topical minoxidil for 4 weeks prior to baseline visit.
* Severe or end-stage CCCA with CHLG as defined as CHLG \>3
* CCCA with frontal accentuation pattern as defin…
What they're measuring
1
Mean Change in Physician Global Assessment of Improvement (PGA-I)