Enstilar in Combination With Biologic Agents

NCT03080545 | Completed Phase 4

• 1 other identifier: PTC01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Physician global assessment multiplied by body surface area improvement after 16 weeks of Enstilar® adjunctive therapy

  pga x bsa

  16 weeks

Secondary Outcomes (3)

• Physician Global Assessment

  16 weeks

• Body Surface area

  16 weeks

• dermatology life quality index; TSQ-9 Treatment Satisfaction Questionnaire

  16 weeks

Study Arms (1)

Open Label Enstilar

EXPERIMENTAL

open label

Drug: Enstilar 0.005%-0.064% Topical Foam

Interventions

Enstilar 0.005%-0.064% Topical Foam DRUG

Topical foam

Open Label Enstilar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adults ≥ 18 years of age.
• Diagnosis of chronic plaque-type psoriasis.
• Able to give written informed consent prior to performance of any study related procedures.
• Treated with a biologic agent for a minimum of 24 weeks at baseline.
• Plaque-type psoriasis as defined at screening and baseline by BSA ≤ 5%.
• 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.
• Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination.

You may not qualify if:

• \>5% Body Surface Area
• Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study.
• Pregnant or breast feeding, or considering becoming pregnant during the study.
• Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
• 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).
• 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).
• Patient received UVB phototherapy within 2 weeks of Baseline.
• Patient received PUVA phototherapy within 4 weeks of Baseline.
• Patient has a known hypersensitivity to the excipients of Enstilar® as stated in the label.

Sponsors & Collaborators

• Psoriasis Treatment Center of Central New Jersey: lead
• LEO Pharma: collaborator

Study Sites (1)

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

betamethasone dipropionate, calcipotriol drug combination

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 15, 2017
• Study Start: May 1, 2017
• Primary Completion: October 30, 2017
• Study Completion: October 30, 2017
• Last Updated: January 3, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)