Apremilast in the Treatment of Central Centrifugal Cicatricial Alopecia (CCCA)
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|ClinicalTrials.gov Identifier: NCT03521687|
Recruitment Status : Recruiting
First Posted : May 10, 2018
Last Update Posted : January 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Central Centrifugal Cicatricial Alopecia||Drug: Apremilast||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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)|
|Official Title:||An Open-label Pilot Study to Investigate the Efficacy of Apremilast in the Treatment of Central Centrifugal Cicatricial Alopecia (CCCA)|
|Actual Study Start Date :||November 15, 2018|
|Estimated Primary Completion Date :||October 15, 2019|
|Estimated Study Completion Date :||October 15, 2019|
Patients with CCCA
30 mg BID
- Change in Physician Global Assessment of Improvement (PGA-I) [ Time Frame: Week 0 and Week 24 ]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).
- Change in CCCA Investigator Global Severity Score (IGSS) [ Time Frame: Week 0 and Week 24 ]Change in IGSS at Week 24 compared to Baseline. Treatment response will be considered no change or improvement in IGSS. CCCA Investigator Global Severity Score (IGSS) assess subjects on a scale of 0 (no hair loss) to 6 (severe CCCA, e.g. >75% involvement of vertex).
- Change in Central Hair Loss Grade (CHLG) [ Time Frame: Week 0 and week 24 ]Change in CHLG at Week 24 compared to Baseline. Degree of severity of hair loss is graded on a 6-point visual scale (pattern 0: no hair loss, pattern 1-2: mild hair loss, pattern 3-5: more severe hair loss).
- Change in subject visual analog scale (VAS) of hair loss severity [ Time Frame: Week 0, Week 12 and Week 24 ]Change in VAS at Week 12 and 24 compared to Baseline. The VAS is a numerical scale used to assess patients' perception of hair loss severity. The evaluation is a 10cm long line on which the subjects indicate the severity of their condition from "0" (complete loss of hair in affected area - ie no visible hairs on central scalp) to "10" (full growth/regrowth in affected area—ie no visible hair loss on central scalp).
- Subject Global Assessment of Improvement [ Time Frame: Week 0 and Week 24 ]Change in PaGA-I at Week 24 as compared to Baseline. PaGA-I will range from -3 (significant worsening) to 3 (significant improvement).
- Change in subject rating of symptom severity questionnaire (NRS) [ Time Frame: Week 0, Week 12 and Week 24 ]Change in NRS at Week 12 and Week 24 as compared to Baseline. Subjects will complete a symptom severity questionnaire consisting of 3 numeric rating scales (NRS) measuring severity of pruritus, burning, and pain. The NRS will range from 0 (no symptoms) to 10 (severe symptoms). Patients indicate the intensity of each symptom (pruritus, burning, or pain) by choosing a number from 0 to 10 that corresponds to the severity of that symptom.
- Change from baseline in Dermatology Life Quality Index (DLQI) total score [ Time Frame: Week 0 and Week 24 ]Change in DLQI total score at Week 24 as compared to Baseline. DLQi is a 10-item questionnaire, each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521687
|United States, New York|
|Mount Sinai West Dermatology||Recruiting|
|New York, New York, United States, 10023|
|Contact: Ingrid Sanabria-Gonzalez 212-523-3812 Ingrid.Sanabria@mountsinai.org|
|Principal Investigator: Andrew Alexis, MD, MPH|
|Principal Investigator:||Andrew Alexis, MD, MPH||Icahn School of Medicine at Mount Sinai|