Apremilast in the Treatment of Central Centrifugal Cicatricial Alopecia (CCCA)

Inclusion Criteria:

• Provide written, signed and dated informed consent prior to initiating anystudy-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 CHLGstages 1B, 2B, 3B
• Punch biopsy at screening, or punch biopsy of the scalp within six months prior toscreening visit, consistent with CCCA
• Females of childbearing potential (FCBP) must have a negative pregnancy test atScreening and Baseline. While on investigational product and for at least 28 daysafter taking the last dose of investigational product, FCBP who engage in activity inwhich 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 historyand physical examination. (NOTE: The definition of good health means a subject doesnot 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), oraltetracycline antibiotics, and oral anti-inflammatory medications
• Topical corticosteroid or calcineurin inhibitor treatment of CCCA for 2 weeks prior tobaseline 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 defined as CHLG 1A to 5A.
• Diagnosis of other dermatologic diagnosis or condition that, in the opinion of theinvestigator, would interfere with diagnosis, examination, or treatment of the studiedcondition (i.e. lichen planopilaris, systemic lupus, cutaneous lupus) or would requiretreatment with systemic steroids, topical or intralesional steroids on the scalp, orsystemic tetracycline antibiotic therapy during the duration of the study.
• Other than the disease under study, any clinically significant (as determined by theInvestigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic,renal, hematologic, immunologic disease, or other major disease that is currentlyuncontrolled.
• Malignancy or history of malignancy, except for: treated [ie, cured] basal cell orsquamous cell in situ skin carcinomas; treated [ie, cured] cervical intraepithelialneoplasia (CIN) or carcinoma in situ of cervix with no evidence of recurrence withinthe previous 5 years.
• Any condition, including the presence of laboratory abnormalities, which would placethe subject at unacceptable risk if he/she were to participate in the study.
• Use of systemic immunosuppressive drugs (including, but not limited to, cyclosporine,corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, or tacrolimus)within four weeks prior to Baseline/Randomization (Visit 2).
• Prior history of suicide attempt at any time in the subject's life time prior toscreening or randomization, or major psychiatric illness requiring hospitalizationwithin the last 3 years.
• Pregnant or breast feeding.
• Subjects not willing to implement the following suggested hair care practices and/ormaintain the same or similar hair style for the duration of study: Shampoo hair every 7 days with a conditioning shampoo; Condition hair every 7 days with a deep orreconstructive conditioner; Towel-dry hair before exposing it to a dryer to minimizeexcessive heat; Comb hair daily with a wide-toothed comb; gently pass the comb throughhair starting from the ends and working your way up to the roots; Avoid heavy pomadesand hair oils to scalp; opt for silicone based products or light pomades to hairshafts; Limit use of styling gels; Limit traction-associated hair styles (e.g. tightbraids, tight weaves, tight cornrows) as determined by investigator; Avoid chemical orthermal injury to scalp during hair styling process; Chemical relaxer treatments canbe used as long as there is no associated scalp injury (i.e. tingling, burning, pain);Maintain the same hair style throughout the study i.e. weave or braids present atbaseline must be maintained through the end of the study; weaves or braids may beredone during the study if needed, but should resemble the subject's hair style atbaseline, if possible.
• Use of any investigational drug within 4 weeks prior to randomization, or 5pharmacokinetic/pharmacodynamics half-lives, if known (whichever is longer).
• Prior treatment with apremilast
• History of allergy to any component of the IP
• Active substance abuse or a history of substance abuse within 6 months prior toScreening.