Topical Scalp Psoriasis Study Evaluating Topicort Topical Spray

NCT ID: NCT02985736

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-01-27

Brief Summary

A single center, study of 20 subjects to assess 4 weeks of therapy with Topicort® twice daily BID and 12 weeks twice daily on 2 consecutive days to patients with scalp psoriasis

Detailed Description

All patients will receive Topicort® twcie daily (BID) for 4 weeks. After week 4 patients will receive Topicort® twice weekly (on consecutive days) for 12 weeks, Patients will treat other body areas affected by plaque psoriasis with Topicort® during the study period (excludes face, groin, axilla)

Conditions

Psoriasis

Study Design

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

Study Groups

open label

Group Type: EXPERIMENTAL

Topicort Topical Spray

Intervention Type: DRUG

Interventions

Topicort Topical Spray

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female adults ≥ 18 years of age.

2. Diagnosis of chronic plaque-type scalp psoriasis.

3. IGA of mild or greater (scalp only) determined at screening

4. Scalp surface area of 30% or greater determined at screening

5. Able to give written informed consent prior to performance of any study related procedures.

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. <30% scalp surface area

2. Scalp Investigator global assessment (IGA) clear or almost clear at time of screening

3. Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study.

4. Pregnant or breast feeding, or considering becoming pregnant during the study.

5. Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).

6. 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).

7. Use of ustekinumab and/or anti-IL-17 (interleukin 17) biologic therapy within 24 weeks or other experimental or commercially available biologic immune modulator(s) within 12 weeks prior to the first IP dose.

8. Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (not including permitted topical therapy for face, groin and axilla).

9. Patient received ultraviolet B, UVB phototherapy within 2 weeks of Baseline.

10. Patient received psoralen and Ultraviolet A, PUVA phototherapy within 4 weeks of Baseline.

11. Patient has a known hypersensitivity to the excipients of Topicort Spray® as stated in the label.

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

Sponsors

Sun Pharmaceutical Industries, Inc.

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

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

JB-02

Identifier Type: -

Identifier Source: org_study_id