Enstilar in Combination With Biologic Agents

NCT ID: NCT03080545

Last Updated: 2018-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2017-10-30

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

Conditions

Psoriasis

Study Design

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

Study Groups

Open Label Enstilar

open label

Group Type: EXPERIMENTAL

Enstilar 0.005%-0.064% Topical Foam

Intervention Type: DRUG

Topical foam

Interventions

Enstilar 0.005%-0.064% Topical Foam

Topical foam

Intervention Type: DRUG

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.

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

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: collaborator

Psoriasis Treatment Center of Central New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States

Countries

United States

Other Identifiers

PTC01

Identifier Type: -

Identifier Source: org_study_id