Topical Scalp Psoriasis Study Evaluating Topicort Topical Spray

An Open-Label, Study Evaluating Topicort® Topical Spray 0.25% (Desoximetasone) in Patients With Scalp Psoriasis

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Topicort Topical Spray

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)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Psoriasis Treatment Center of Central New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: open label	Drug: Topicort Topical Spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator Global Assessment (Scalp Only)	Scalp psoriasis severity scale (score 0-4 where 0 is no psoriasis and 4 is severe)	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body surface area multiplied by physician's global assessement	measures psoriasis severity improvement	16 weeks
scalpdex questionnaire	patient reported outcome	16 weeks
visual analog scale	measures subject assessment of pain	16 weeks

Collaborators and Investigators

• Sponsor: Psoriasis Treatment Center of Central New Jersey
• Collaborators: Taro Pharmaceuticals USA

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): January 27, 2017
• Study Completion (Actual): January 27, 2017

Study Registration Dates

• First Submitted: October 5, 2016
• First Submitted That Met QC Criteria: December 5, 2016
• First Posted (Estimated): December 7, 2016

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Desoximetasone
• Other Study ID Numbers: JB-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO