Effects of Desoximetasone Spray 0.25% on Moderate to Severe Plaque Psoriasis

NCT ID: NCT01206387

Last Updated: 2017-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-01-31

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

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

active product

Desoximetasone Spray 0.25%

Group Type: EXPERIMENTAL

Desoximetasone Spray 0.25%

Intervention Type: DRUG

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

placebo comparator

vehicle

Group Type: PLACEBO_COMPARATOR

placebo comparator

Intervention Type: DRUG

Placebo administered to affected area twice a day for 28 days

Interventions

Desoximetasone Spray 0.25%

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

Intervention Type: DRUG

placebo comparator

Placebo administered to affected area twice a day for 28 days

Intervention Type: DRUG

Other Intervention Names

Desoximetasone; vehicle

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Pharmaceutical Industries, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novum Pharmaceutical Research Services

Role: STUDY_CHAIR

http://www.novumprs.com/contact

References

Saleem MD, Negus D, Feldman SR. Topical 0.25% desoximetasone spray efficacy for moderate to severe plaque psoriasis: a randomized clinical trial. J Dermatolog Treat. 2018 Feb;29(1):32-35. doi: 10.1080/09546634.2017.1331027. Epub 2017 May 30.

Reference Type: DERIVED

PMID: 28504031 (View on PubMed)

Other Identifiers

DSXS-0808

Identifier Type: -

Identifier Source: org_study_id