Topical Scalp Psoriasis Study Evaluating Topicort Topical Spray

NCT02985736 | Completed Phase 4 Results

• 1 other identifier: JB-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Investigator Global Assessment (Scalp Only)

  Scalp psoriasis severity scale (score 0-4 where 0 is no psoriasis and 4 is severe)

  16 weeks

Study Arms (1)

open label

EXPERIMENTAL

Drug: Topicort Topical Spray

Interventions

Topicort Topical Spray DRUG

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 scalp psoriasis.
• IGA of mild or greater (scalp only) determined at screening
• Scalp surface area of 30% or greater determined at screening
• Able to give written informed consent prior to performance of any study related procedures.
• 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:

• \<30% scalp surface area
• Scalp Investigator global assessment (IGA) clear or almost clear at time of screening
• 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).
• 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.
• Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (not including permitted topical therapy for face, groin and axilla).
• Patient received ultraviolet B, UVB phototherapy within 2 weeks of Baseline.
• Patient received psoralen and Ultraviolet A, 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

Study Sites (1)

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location

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

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 7, 2016
• Study Start: September 1, 2016
• Primary Completion: January 27, 2017
• Study Completion: January 27, 2017
• Last Updated: April 9, 2024
• Results First Posted: April 9, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)