Apremilast in the Treatment of Central Centrifugal Cicatricial Alopecia (CCCA)
Condition: Central Centrifugal Cicatricial Alopecia
MeSH terms: Alopecia; Alopecia Areata
Intervention: Apremilast
Intervention description: 30 mg BID
Intervention MeSH terms: Apremilast
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This is an open-label study that will enroll 20 subjects with central centrifugal cicatricial alopecia. All subjects will receive apremilast.
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Central centrifugal cicatricial alopecia; open-label pilot study

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.
    

Eligibility criteria:

        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 defined as CHLG 1A to 5A.

          -  Diagnosis of other dermatologic diagnosis or condition that, in the opinion of the
             investigator, would interfere with diagnosis, examination, or treatment of the studied
             condition (i.e. lichen planopilaris, systemic lupus, cutaneous lupus) or would require
             treatment with systemic steroids, topical or intralesional steroids on the scalp, or
             systemic tetracycline antibiotic therapy during the duration of the study.

          -  Other than the disease under study, any clinically significant (as determined by the
             Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic,
             renal, hematologic, immunologic disease, or other major disease that is currently
             uncontrolled.

          -  Malignancy or history of malignancy, except for: treated [ie, cured] basal cell or
             squamous cell in situ skin carcinomas; treated [ie, cured] cervical intraepithelial
             neoplasia (CIN) or carcinoma in situ of cervix with no evidence of recurrence within
             the previous 5 years.

          -  Any condition, including the presence of laboratory abnormalities, which would place
             the 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 to
             screening or randomization, or major psychiatric illness requiring hospitalization
             within the last 3 years.

          -  Pregnant or breast feeding.

          -  Subjects not willing to implement the following suggested hair care practices and/or
             maintain 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 or
             reconstructive conditioner; Towel-dry hair before exposing it to a dryer to minimize
             excessive heat; Comb hair daily with a wide-toothed comb; gently pass the comb through
             hair starting from the ends and working your way up to the roots; Avoid heavy pomades
             and hair oils to scalp; opt for silicone based products or light pomades to hair
             shafts; Limit use of styling gels; Limit traction-associated hair styles (e.g. tight
             braids, tight weaves, tight cornrows) as determined by investigator; Avoid chemical or
             thermal injury to scalp during hair styling process; Chemical relaxer treatments can
             be 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 at
             baseline must be maintained through the end of the study; weaves or braids may be
             redone during the study if needed, but should resemble the subject's hair style at
             baseline, if possible.

          -  Use of any investigational drug within 4 weeks prior to randomization, or 5
             pharmacokinetic/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 to
             Screening.