Enstilar in Combination With Biologic Agents

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 30, 2017

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

Interventions

  • Drug: Enstilar 0.005%-0.064% Topical Foam
    • Topical foam

Arms, Groups and Cohorts

  • Experimental: Open Label Enstilar
    • open label

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Psoriasis Treatment Center of Central New Jersey
  • Collaborator
    • LEO Pharma
  • Provider of Information About this Clinical Study
    • Sponsor

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