Topical Psoriasis Study for Patients Receiving Biologic Therapy

NCT ID: NCT02983981

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-10-31

Brief Summary

A two-phase, single center, study of 20 subjects to assess 4 weeks of add-on therapy of Topicort® BID and 12 weeks BID on two consecutive days a week to patients with ≤5% BSA who are receiving biologic therapy for at least 24 weeks

Detailed Description

A two-phase, single center, study of 20 subjects to assess 4 weeks of add-on therapy of Topicort® BID and 12 weeks BID on two consecutive days a week to patients with ≤5% BSA who are receiving biologic therapy for at least 24 weeks.

Adult male and female subjects with moderate to severe chronic plaque psoriasis All patients will receive Topicort® BID for 4 weeks.

After week 4 patients will receive Topicort® BID on two consecutive days a week for 12 weeks.

Conditions

Psoriasis

Study Design

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

Study Groups

open label

Topicort topical spray

Group Type: EXPERIMENTAL

Topicort Topical Spray

Intervention Type: DRUG

open label Topicort spray

Interventions

Topicort Topical Spray

open label Topicort spray

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. Malignancy or history of malignancy, except for:

1. treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;

2. treated [ie, cured] malignancy with no evidence of recurrence within the previous 5 years.

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. 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).

8. Patient received UVB phototherapy within 2 weeks of Baseline.

9. Patient received PUVA phototherapy within 4 weeks of Baseline.

10. 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

Principal Investigators

Jerry Bagel, MD

Role: PRINCIPAL_INVESTIGATOR

Director

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

JB-01

Identifier Type: -

Identifier Source: org_study_id