Status:
UNKNOWN
Trial Evaluating the Efficacy of Apremilast for the Treatment of Frontal Fibrosing Alopecia
Lead Sponsor:
Bellevue Dermatology
Collaborating Sponsors:
Celgene
Conditions:
Frontal Fibrosing Alopecia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 Front...
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 r...
Eligibility Criteria
Inclusion
- 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).
- Male or Female and is at least 18 years of age, at the time of enrollment.
- 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).
- Patients with an established diagnosis of FFA based on the enrolling investigator's clinical judgment
- Patients who have been treated and failed one standard therapy including
- Topical steroids
- Short course systemic steroids
- Systemic antibiotics
- Patients who are on stable dose of topical steroids or systemic antibiotics
- 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
- 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.
- 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.
- 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.
- Active substance abuse or a history of substance abuse within 6 months prior to Screening.
- 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.
- Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
- Prior treatment with apremilast.
- Patient who have underlying chronic infections including HIV, Hep B and C.
- History of uncontrolled depression.
Key Trial Info
Start Date :
July 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03422640
Start Date
July 12 2018
End Date
January 1 2019
Last Update
July 16 2018
Active Locations (1)
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1
Bellevue Dermatology
Bellevue, Washington, United States, 98004