Enstilar in Combination With Biologic Agents

Phase 4

Completed

• Conditions: Psoriasis
• Interventions: Drug: Enstilar 0.005%-0.064% Topical Foam

• Registration Number: NCT03080545
• Lead Sponsor: Psoriasis Treatment Center of Central New Jersey

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

Study Timeline

• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-03-09
• Study First Posted: 2017-03-15
• Study Start: 2017-05-01
• Primary Completion: 2017-10-30
• Study Completion: 2017-10-30
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-29
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label Enstilar	Enstilar 0.005%-0.064% Topical Foam	open label

Primary Outcome Measures

Name	Time	Method
Physician global assessment multiplied by body surface area improvement after 16 weeks of Enstilar® adjunctive therapy	16 weeks	pga x bsa

Secondary Outcome Measures

Name	Time	Method
dermatology life quality index; TSQ-9 Treatment Satisfaction Questionnaire	16 weeks	satisfaction determined by patient reported outcomes
Physician Global Assessment	16 weeks	PGA
Body Surface area	16 weeks	BSA

Trial Locations

Locations (1)

Psoriasis Treatment Center of Central New Jersey; 🇺🇸 East Windsor, New Jersey, United States