Enstilar in Combination With Biologic Agents



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:1/5/2018
Start Date:May 1, 2017
End Date:October 30, 2017

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An Open-Label, Study Evaluating Enstilar® (Calcipotriene and Betamethasone Dipropionate) Foam, 0.005%/0.064% QD in Psoriasis Patients Being Treated With Biologic Agents

Patients receiving biologic therapy with 5% or less body surface area will receive Enstilar
topical foam for 16 weeks.

A two-phase, single center, observational study of 25 subjects to assess 4 weeks of
adjunctive therapy of Enstilar® QD followed by 12 weeks QD on two consecutive days a week to
patients with ≤5% BSA who are receiving biologic therapy for at least 24 weeks

Inclusion Criteria:

1. Male or female adults ≥ 18 years of age.

2. Diagnosis of chronic plaque-type psoriasis.

3. Able to give written informed consent prior to performance of any study related
procedures.

4. Treated with a biologic agent for a minimum of 24 weeks at baseline.

5. Plaque-type psoriasis as defined at screening and baseline by BSA ≤ 5%.

6. Females of childbearing potential (FCBP) must have a negative pregnancy test at
Screening and Baseline. FCBP who engage in activity in which conception is possible
must use one of the approved contraceptive options: hormonal contraception;
intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female
condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive
sponge with spermicide.

7. Subject must be in general good health (except for psoriasis) as judged by the
Investigator, based on medical history, physical examination.

Exclusion Criteria:

1. >5% Body Surface Area

2. Any condition, which would place the subject at unacceptable risk if he/she were to
participate in the study.

3. Pregnant or breast feeding, or considering becoming pregnant during the study.

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

5. Use of oral systemic medications for the treatment of psoriasis within 4 weeks
(includes, but not limited to, oral corticosteroids, methotrexate, acitretin,
apremilast and cyclosporine).

6. Patient used other topical therapies to treat within 2 weeks of the Baseline Visit
(includes, but not limited to, topical corticosteroids, vitamin D analogs, or
retinoids).

7. Patient received UVB phototherapy within 2 weeks of Baseline.

8. Patient received PUVA phototherapy within 4 weeks of Baseline.

9. Patient has a known hypersensitivity to the excipients of Enstilar® as stated in the
label.
We found this trial at
1
site
59 One Mile Road
East Windsor, New Jersey 08520
609-443-4500
?
mi
from
East Windsor, NJ
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