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

NCT03521687 | Completed Phase 4 Results FDA Drug

• 1 other identifier: GCO 17-2386
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Centrifugal Cicatricial Alopecia

Keywords

Central centrifugal cicatricial alopecia; open-label pilot study

Outcome Measures

Primary Outcomes (1)

• Mean Change in Physician Global Assessment of Improvement (PGA-I)

  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).

  Week 0 and Week 24

Secondary Outcomes (6)

• 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

• Change in Subject Rating of Symptom Severity Questionnaire (NRS)

  Week 0 and Week 24

Study Arms (1)

Apremilast

EXPERIMENTAL

Patients with CCCA

Drug: Apremilast

Interventions

Apremilast DRUG

30 mg BID

Apremilast

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only female subjects will be enrolled.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai West Dermatology

New York, New York, 10023, United States

Location

MeSH Terms

Interventions

apremilast

Results Point of Contact

• Title: Ingrid Sanabria-Gonzalez
• Organization: Icahn School of Medicine at Mount Sinai

ingrid.sanabria@mountsinai.org

212-523-3812

Study Officials

• Saakshi Khattri, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is an open-label study that will enroll 20 subjects with central centrifugal cicatricial alopecia. All subjects will receive apremilast.

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 11, 2018
• Study Start: November 15, 2018
• Primary Completion: February 12, 2021
• Study Completion: February 12, 2021
• Last Updated: May 9, 2022
• Results First Posted: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)