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

NCT01206660 | Completed Phase 3 Results

• 1 other identifier: DSXS-0914
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Physician's Global Assessment (PGA) of Psoriasis Score at Day 28.

  Day 28

Study Arms (2)

Desoximetasone Spray 0.25%

EXPERIMENTAL

Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days

Drug: Desoximetasone Spray 0.25%

placebo

PLACEBO COMPARATOR

Placebo administered to affected area twice a day for 28 days

Drug: placebo

Interventions

Desoximetasone Spray 0.25% DRUG

Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days

Desoximetasone Spray 0.25%

placebo DRUG

Placebo administered to affected area twice a day for 28 days

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

Study Sites (1)

Investigator Site

Hazleton, Pennsylvania, United States

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Taro Pharmaceuticals U.S.A., Inc.

natalie.yantovskiy@taro.com

914-345-9001

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2010
• First Posted: September 22, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: July 3, 2014
• Results First Posted: July 3, 2014

Record last verified: 2014-06

Locations

US (1)