A Double-Blind, Vehicle-Controlled, Randomized, Parallel Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone 0.25% Topical Spray in Patients With Moderate to Severe Plaque Psoriasis

Taro Pharmaceuticals USA0 sites120 target enrollmentAugust 2010

ConditionsPsoriasis

InterventionsDesoximetasone Spray 0.25%placebo comparator

DrugsDesoximetasone Spray 0.25%placebo comparator

Overview

Phase: Phase 3
Intervention: Desoximetasone Spray 0.25%
Conditions: Psoriasis
Sponsor: Taro Pharmaceuticals USA
Enrollment: 120
Primary Endpoint: Clinical Success
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

efficacy study in patients with moderate to severe plaque psoriasis.

Detailed Description

A Double-Blind, Vehicle-Controlled, Randomized, Parallel Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone 0.25% Topical Spray in Patients with Moderate to Severe Plaque Psoriasis

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

January 2011

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Taro Pharmaceuticals USA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or non-pregnant, non-lactating female 18 years of age or older.
•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

•Patient has current diagnosis of other types of psoriasis other than stable plaque psoriasis (i.e. acute, guttate, erythrodermic, exfoliative or pustular psoriasis) or has psoriasis of any kind of the face or scalp that will require active treatment during the study. Nonprescription antipsoriatic shampoos will be allowed during the study when applied solely to the scalp.
•Patient has a history of psoriasis that has been unresponsive to topical corticosteroid therapy.
•In the Investigator's opinion, the patient has other dermatological conditions, such as atopic or contact dermatitis, that may interfere with the clinical assessments of the signs and symptoms of psoriasis.
•Patient has a history of allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the patient or the results of the study.
•Patient has been treated within 12 weeks (or five half lives, whichever is less) prior to the first dose of study drug with any biological therapies for psoriasis.
•Patient has received any 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.
•Patients who have used any 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.

Arms & Interventions

active product

Desoximetasone Spray 0.25%

Intervention: Desoximetasone Spray 0.25%

placebo comparator

vehicle

Intervention: placebo comparator

Outcomes

Primary Outcomes

Clinical Success

Time Frame: 28 days

A patient is considered a Clinical Success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear).

Treatment Success

Time Frame: 28 days

A patient is considered a Treatment Success for the Target Lesions if the target lesion has a score of 0 or 1 on the Target Lesion Severity Score (TLSS)for each of each of the three signs and symptoms (erythema, scaling and plaque elevation).

Secondary Outcomes

Mean Change From Baseline in Physician Global Assessment (PGA) Score at Day 28 Using ITT.(Baseline and day 28)
Mean Change From Baseline in Total Lesion Severity Scale (TLSS) (ITT)(Baseline and day 28)
Mean Change From Baseline in Percent Body Surface Area (%BSA) Affected at Day 28(Baseline and day 28)