An Open-label Pilot Study to Investigate the Efficacy of Apremilast in the Treatment of Central Centrifugal Cicatricial Alopecia (CCCA)
Overview
- Phase
- Phase 4
- Intervention
- Apremilast
- Conditions
- Central Centrifugal Cicatricial Alopecia
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Mean Change in Physician Global Assessment of Improvement (PGA-I)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed Description
Central centrifugal cicatricial alopecia (CCCA) is a type of scarring alopecia commonly seen in women of African American descent. The etiology is not completely understood, but CCCA likely results from a combination of hair-grooming practices, a pro-inflammatory state within the hair follicles, and genetic factors. The management of CCCA remains a challenge as there are no published treatment guidelines. Current therapies aim to decrease inflammation in order to prevent further hair loss. Apremilast, an oral phosphodiesterase-4 inhibitor, has been shown to be effective in the treatment of moderate to severe plaque psoriasis and psoriatic arthropathy. In vitro studies have demonstrated anti-inflammatory properties via inhibition of inflammatory mediators. Therefore, apremilast offers a possible therapeutic option for CCCA. This will be a single-center, open-label clinical study to determine the efficacy of apremilast in the treatment of mild to moderate central centrifugal cicatricial alopecia.
Investigators
Saakshi Khattri
Assistant Professor
Icahn School of Medicine at Mount Sinai
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).
Arms & Interventions
Apremilast
Patients with CCCA
Intervention: Apremilast
Outcomes
Primary Outcomes
Mean Change in Physician Global Assessment of Improvement (PGA-I)
Time Frame: Week 0 and Week 24
Mean change in PGA-I at Week 24 compared to Baseline. Trained study personnel will take standardized photographs of the scalp. These photographs will be provided to a panel of three dermatologists with expertise in CCCA, each of whom will review the photographs at these time points. Investigators will assess the improvement in hair loss severity using PGA-I. PGA-I will range from -3 (significant worsening) to 3 (significant improvement).
Secondary Outcomes
- Change in Subject Rating of Symptom Severity Questionnaire (NRS)(Week 0 and Week 24)
- Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score(Week 0 and Week 24)
- Mean Change in CCCA Investigator Global Severity Score (IGSS)(Week 0 and Week 24)
- Mean Change in Central Hair Loss Grade (CHLG)(Week 0 and week 24)
- Mean Change in Subject Visual Analog Scale (VAS) of Hair Loss Severity(Week 0 and Week 24)
- Mean Change in Subject Global Assessment of Improvement(Week 0 and Week 24)