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Desoximetasone Spray 0.05%, 0.25%; Dose Ranging Study

Information source: Taro Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis

Intervention: Desoximetasone 0.05% once daily (Drug); Desoximetasone 0.05% twice daily (Drug); Desoximetasone 0.25% once daily (Drug); Desoximetasone 0.25% once daily (Drug); Vehicle once daily (Drug); Vehicle twice daily (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Taro Pharmaceuticals USA

Summary

The objectives of this study are to evaluate the efficacy and safety of two dosing regimens of desoximetasone 0. 05% and 0. 25% topical sprays as compared to a vehicle spray in patients with moderate to severe plaque psoriasis.

Clinical Details

Official title: A Double-Blind, Vehicle-Controlled, Randomized, Dose Ranging, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone Topical Sprays (0.05%, 0.25%) in Patients With Moderate to Severe Plaque Psoriasis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28

Number of Participants in Each Treatment Group With Treatment Success for the Target Lesion (Total Lesion Severity Scale (TLSS) a Score of 0 or 1).

Secondary outcome:

Mean Change From Baseline in PGA Score at Day 28 Using the ITT

Mean Change From Baseline in Total Lesion Severity Score (TLSS) at Day 28

Mean Change From Baseline in %Body Surface Area (%BSA) Affected at Day 28 (or Early Termination).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Have a definite clinical diagnosis of stable plaque psoriasis involving ≥ 10% of the

body surface area (BSA).

- Have a combined total lesion severity score (TLSS) of ≥ 7 for the target lesion.

- Have a plaque elevation score ≥ 3 of (moderate) for the target lesion.

- The target lesion must have an area of at least 5 cm².

- Have a Physicians Global Assessment (PGA) score of 3 (moderate) or 4 (severe) at

baseline for the overall disease severity. Exclusion Criteria:

- Pregnancy

- Current diagnosis of other types of psoriasis other than stable plaque psoriasis or

has psoriasis of any kind of the face or scalp that will require active treatment during the study.

- History of psoriasis that has been unresponsive to topical corticosteroid therapy.

- Dermatological conditions that may interfere with the clinical assessments of the

signs and symptoms of psoriasis.

- Allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or

intolerance which would compromise the safety of the patient or the results of the study.

- Any condition that would place the study patient at undue risk by participation in

the study.

- Radiation therapy, antineoplastic agents or immunosuppressant medication within 4

weeks prior to the first dose of study drug.

- Treatment with any systemic or photo antipsoriatic therapy, within 8 weeks of the

first dose of study drug.

- Treatment within 12 weeks (or five half lives, whichever is less) prior to the first

dose of study drug with any biological therapies for psoriasis.

- Systemic steroids within 4 weeks of the first dose of the study drug. The use of

inhaled or intranasal corticosteroids is acceptable as long as usage has been stable for at least 2 weeks prior to the first dose of study drug and will be continued during the study.

- Hormonal contraceptives for less than one complete cycle prior to entering the study.

- Topical antipsoriatic agents of any kind or any topical corticosteroids for any

reason within 2 weeks prior to first use of study drug. Nonprescription antipsoriatic shampoos used only on the scalp will be allowed during the study.

- Receipt of any drug as part of a research study within 30 days prior to first dosing.

Locations and Contacts

Investigator Site, Miami, Florida, United States

Investigator Site, Martinez, Georgia, United States

Investigator Site, Olathe, Kansas, United States

Investigator Site, Wichita, Kansas, United States

Investigator Site, Albuquerque, New Mexico, United States

Investigator Site, Cincinnati, Ohio, United States

Investigator Site, Simpsonville, South Carolina, United States

Additional Information

Starting date: November 2009
Last updated: July 9, 2014

Page last updated: August 23, 2015

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