Trial Evaluating the Efficacy of Apremilast for the Treatment of Frontal Fibrosing Alopecia

NCT ID: NCT03422640

Last Updated: 2018-07-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-12
• Study Completion Date: 2019-01-31

Brief Summary

This is open label single side study involvement 20 patient treated with Apremilast. Each enrolled patient may be evaluated at by a dermatologist using the Lichen Planopilaris Activity Index and Frontal Fibrosing Alopecia Index. Other measures include physician global assessment, dermatology quality of life and patients analogue score for pruritus. Pt will have visits at Week 0,2,4,8,12,16,20,24

Detailed Description

Frontal fibrosing alopecia (FFA) is a chronic immune mediated inflammatory disease characterized by inflammation of the hair follicle and scaring hair loss. Clinically, FFA presents as a progressive recession of the hairline in a frontal temporal distribution. Evidence suggests that timely and effective management can prevent the permanent loss of hair. Unfortunately, most current treatment have been disappointing with poor efficacy or high risk profile. The available of a safe effective treatment for this disease remains an unmet need Apremilast is a novel phosphodiesterase 4 inhibitor currently FDA approved to treat psoriasis and is under investigation for other auto immune conditions. The medication has a good safety profile with no required laboratory monitoring. This study primarily aimsto determine whether Apremilast offers any benefit for this difficult to treatment population

Conditions

Frontal Fibrosing Alopecia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment arm with apremilast

Open label arm treating frontal fibrosing alopecia with apremilast

Group Type: EXPERIMENTAL

Apremilast

Intervention Type: DRUG

Open label treatment with apremilast

Interventions

Apremilast

Open label treatment with apremilast

Intervention Type: DRUG

Other Intervention Names

Otezla

Eligibility Criteria

Inclusion Criteria

1. Must be in general good health (except for disease under study) as judged by the Investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).

2. Male or Female and is at least 18 years of age, at the time of enrollment.

3. 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 described below: Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; 3. OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on investigational product and for at least 28 days after the last dose of investigational product.

• † A female of childbearing potential is a sexually mature female who 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) consecutive months (that is, has had menses at any time during the preceding 24 consecutive months).
• § The female subject's chosen form of contraception must be effective by the time the female subject is randomized into the study (for example, hormonal contraception should be initiated at least 28 days before randomization).

4. Patients with an established diagnosis of FFA based on the enrolling investigator's clinical judgment

5. Patients who have been treated and failed one standard therapy including

• Topical steroids
• Short course systemic steroids
• Systemic antibiotics

6. Patients who are on stable dose of topical steroids or systemic antibiotics

7. Patient and/or legal guardian has voluntarily signed and dated an informed consent/patient authorization form approved by an Institutional Review Board (IRB)/Ethics Committee (EC) if applicable according to local law, after the nature of the study has been explained and the patient has had the opportunity to ask questions.

Exclusion Criteria

1. Other than 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.

2. 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.

3. 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.

4. Pregnant or breast feeding.

5. Active substance abuse or a history of substance abuse within 6 months prior to Screening.

6. Malignancy or history of malignancy, except for: a. treated [ie, cured] basal cell or squamous cell in situ skin carcinomas; b. treated [ie, cured] cervical intraepithelial neoplasia (CIN) or carcinoma in situ of cervix with no evidence of recurrence within the previous 5 years.

7. Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).

8. Prior treatment with apremilast.

9. Patient who have underlying chronic infections including HIV, Hep B and C.

10. History of uncontrolled depression.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: collaborator

Bellevue Dermatology

OTHER

Sponsor Role: lead

Responsible Party

Clive Liu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Clive Liu, MD

Role: STUDY_DIRECTOR

Bellevue Dermatology

Locations

Bellevue Dermatology

Bellevue, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clive M Liu, MD

Role: CONTACT

Cliveliumd@gmail.com

425-455-2275

Ivy T Chan, BA

Role: CONTACT

Gcpchan@aol.com

510-332-4783

Facility Contacts

Clive M Liu, MD

Role: primary

Cliveliumd@gmail.com

425-455-2275

Other Identifiers

BD1-1

Identifier Type: -

Identifier Source: org_study_id