Clinical trial NCT03080545: Enstilar in Combination With Biologic Agents
Official title: An Open-Label, Study Evaluating Enstilar® (Calcipotriene and Betamethasone Dipropionate) Foam, 0.005%/0.064% QD in Psoriasis Patients Being Treated With Biologic Agents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: Psoriasis Treatment Center of Central New Jersey
Sponsor class: OTHER
Collaborators: name: LEO Pharma
First posted: 2017-03-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Physician global assessment multiplied by body surface area improvement after 16 weeks of Enstilar® adjunctive therapy
timeFrame: 16 weeks
Secondary outcomes:
measure: Physician Global Assessment
timeFrame: 16 weeks
measure: Body Surface area
timeFrame: 16 weeks
measure: dermatology life quality index; TSQ-9 Treatment Satisfaction Questionnaire
timeFrame: 16 weeks
Other outcomes:
Locations:
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
Study officials:
References: