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COMPLETEDPHASE4

Topical Scalp Psoriasis Study Evaluating Topicort Topical Spray

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

NCT02985736•Psoriasis Treatment Center of Central New Jersey

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)

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Locations (1)

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States

Key Dates

Start Date

September 1, 2016

Primary Completion Date

January 27, 2017

Completion Date

January 27, 2017

Last Updated

April 9, 2024

Enrollment

ACTUAL participants

Conditions

Psoriasis

Interventions

Topicort Topical Spray

DRUG

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 9, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Topical Scalp Psoriasis Study Evaluating Topicort Topical Spray

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments