Desoximetasone Spray 0.05%, 0.25%; Dose Ranging Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Desoximetasone 0.05% once daily

Desoximetasone topical spray 0.05% administered once daily to affected area

Group Type EXPERIMENTAL

Desoximetasone 0.05% once daily

Intervention Type DRUG

Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days

Desoximetasone 0.05% twice daily

Desoximetasone topical spray 0.05% administered twice daily to affected area

Group Type EXPERIMENTAL

Desoximetasone 0.05% twice daily

Intervention Type DRUG

Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days

Desoximetasone 0.25% once daily

Desoximetasone topical spray 0.25% administered once daily to affected area

Group Type EXPERIMENTAL

Desoximetasone 0.25% once daily

Intervention Type DRUG

Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days

Desoximetasone 0.25% twice daily

Desoximetasone topical spray 0.25% administered twice daily to affected area

Group Type EXPERIMENTAL

Desoximetasone 0.25% once daily

Intervention Type DRUG

Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days

Vehicle once daily

Vehicle administered to affected areas once daily

Group Type PLACEBO_COMPARATOR

Vehicle once daily

Intervention Type DRUG

Vehicle topical spray administered to affected areas once daily for 28 days

Vehicle twice daily

Vehicle administered to affected areas twice daily

Group Type PLACEBO_COMPARATOR

Vehicle twice daily

Intervention Type DRUG

Vehicle topical spray administered to affected areas twice daily for 28 days

Interventions

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Desoximetasone 0.05% once daily

Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days

Intervention Type DRUG

Desoximetasone 0.05% twice daily

Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days

Intervention Type DRUG

Desoximetasone 0.25% once daily

Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days

Intervention Type DRUG

Desoximetasone 0.25% once daily

Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days

Intervention Type DRUG

Vehicle once daily

Vehicle topical spray administered to affected areas once daily for 28 days

Intervention Type DRUG

Vehicle twice daily

Vehicle topical spray administered to affected areas twice daily for 28 days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No