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Apremilast in the Treatment of Central Centrifugal Cicatricial Alopecia (CCCA) | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

An Open-label Pilot Study to Investigate the Efficacy of Apremilast in the Treatment of Central Centrifugal Cicatricial Alopecia (CCCA)

NCT03521687•Icahn School of Medicine at Mount Sinai

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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).
+7 more criteria

Locations (1)

Mount Sinai West Dermatology

New York, New York, United States

Key Dates

Start Date

November 15, 2018

Primary Completion Date

February 12, 2021

Completion Date

February 12, 2021

Last Updated

May 9, 2022

Enrollment

ACTUAL participants

Conditions

Central Centrifugal Cicatricial Alopecia

Interventions

Apremilast

DRUG

Effect of Platelet-Rich Plasma Versus Placebo in the Treatment of Central Centrifugal Cicatricial Alopecia

NCT06998433

Central Centrifugal Cicatricial Alopecia

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COMPLETEDNA

Follicular Revival in Fibrosing Alopecia: Evaluating Use of Micro-needling

NCT04342091

Fibrosing AlopeciaFrontal Fibrosing Alopecia+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 9, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Effect of Platelet-Rich Plasma Versus Placebo in the Treatment of Central Centrifugal Cicatricial Alopecia

Follicular Revival in Fibrosing Alopecia: Evaluating Use of Micro-needling

Barriers to Care and QOL for CCCA Patients