Topical Psoriasis Study for Patients Receiving Biologic Therapy

NCT02983981 | Completed Phase 4 Results

• 1 other identifier: JB-01
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Psoriasis Severity

  Physician's Global Assessment x Percentage of Body Surface Area (scale scores 0-400 where 0 is best psoriasis 400 is worst possible psoriasis) Body surface area calculated as 1 of patient's palm is 1%.

  16 weeks

Secondary Outcomes (3)

• Psoriasis Severity

  16 weeks

• Psoriasis Severity

  16 weeks

• Dermatology Life Quality Index

  16 weeks

Study Arms (1)

open label

EXPERIMENTAL

Topicort topical spray

Drug: Topicort Topical Spray

Interventions

Topicort Topical Spray DRUG

open label Topicort spray

open label

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.
• Malignancy or history of malignancy, except for:
• treated \[ie, cured\] basal cell or squamous cell in situ skin carcinomas;
• treated \[ie, cured\] malignancy with no evidence of recurrence within the previous 5 years.
• 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 Topicort Spray® as stated in the label.

Sponsors & Collaborators

• Psoriasis Treatment Center of Central New Jersey: lead
• Sun Pharmaceutical Industries, Inc.: collaborator

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jerry Bagel Director of Clinical Trials
• Organization: Psoriasis Treatment Center of Central New Jersey

dreamacres1@aol.com

6094434500

Study Officials

• Jerry Bagel, MD

  Director

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: October 5, 2016
• First Posted: December 6, 2016
• Study Start: March 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: March 20, 2024
• Results First Posted: May 7, 2018

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share