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

Inclusion Criteria:

1. Must be in general good health (except for disease under study) as judged by theInvestigator, based on medical history, physical examination, clinical laboratories,and urinalysis. (NOTE: The definition of good health means a subject does not haveuncontrolled 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 atScreening and Baseline. While on investigational product and for at least 28 daysafter taking the last dose of investigational product, FCBP who engage in activity inwhich conception is possible must use one of the approved contraceptive§ optionsdescribed below: Option 1: Any one of the following highly effective methods: hormonalcontraception (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) contraceptivesponge with spermicide. Male subjects (including those who have had a vasectomy) whoengage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] membrane [forexample, polyurethane]) while on investigational product and for at least 28 daysafter the last dose of investigational product.

• † A female of childbearing potential is a sexually mature female who 1) has notundergone a hysterectomy (the surgical removal of the uterus) or bilateraloophorectomy (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 timethe female subject is randomized into the study (for example, hormonalcontraception should be initiated at least 28 days before randomization).

4. Patients with an established diagnosis of FFA based on the enrolling investigator'sclinical 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 informedconsent/patient authorization form approved by an Institutional Review Board (IRB)/Ethics Committee (EC) if applicable according to local law, after the nature ofthe 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 theInvestigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic,renal, hematologic, immunologic disease, or other major disease that is currentlyuncontrolled.

2. Any condition, including the presence of laboratory abnormalities, which would placethe 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 toscreening or randomization, or major psychiatric illness requiring hospitalizationwithin the last 3 years.

4. Pregnant or breast feeding.

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

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

7. Use of any investigational drug within 4 weeks prior to randomization, or 5pharmacokinetic/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.