Effects of Desoximetasone Spray 0.25% in Patients With Moderate to Severe Plaque Psoriasis

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01206660
• Other study ID #: DSXS-0914
• Status: Completed
• Phase: Phase 3
• First received: September 20, 2010
• Last updated: June 3, 2014
• Start date: August 2010
• Est. completion date: January 2011

Study information

• Verified date: June 2014
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to demonstrate that desoximetasone 0.25% topical spray is effective for the treatment of patients with moderate to severe plaque psoriasis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Desoximetasone Spray 0.25%
Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
• placebo
Placebo administered to affected area twice a day for 28 days

Locations

Country	Name	City	State
United States	Investigator Site	Hazleton	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Success ITT	A patient is considered a Clinical Success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear).	28 days	No
Primary	Treatment Success	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 the three signs and symptoms (erythema, scaling and plaque elevation).	Day 28	No
Secondary	Physician's Global Assessment (PGA) of Psoriasis Score at Day 28.	Physician Global Assessment (PGA) of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of face, genitals, or intertriginous area (i.e., breast fold, gluteal crease, axilla). Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease.	Day 28	No