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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
Sponsor:
Information provided by (Responsible Party):
Andrew Alexis, MD, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Central Centrifugal Cicatricial Alopecia Drug: Apremilast Phase 4

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.


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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)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Apremilast
Patients with CCCA
Drug: Apremilast
30 mg BID




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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.

  6. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only female subjects will be enrolled.
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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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         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Andrew Alexis, MD, MPH Icahn School of Medicine at Mount Sinai

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Responsible Party: Andrew Alexis, MD, Chair, Department of Dermatology, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03521687     History of Changes
Other Study ID Numbers: GCO 17-2386
First Posted: May 10, 2018    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be shared with Celgene, who is providing a grant for this study.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrew Alexis, MD, Icahn School of Medicine at Mount Sinai:
Central centrifugal cicatricial alopecia
open-label pilot study
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Thalidomide
Apremilast
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents