Clinical trial NCT01018134: Desoximetasone Spray 0.05%, 0.25%; Dose Ranging Study
Official title: A Double-Blind, Vehicle-Controlled, Randomized, Dose Ranging, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone Topical Sprays (0.05%, 0.25%) in Patients With Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: Psoriasis
Topical corticosteroids
Plaque psoriasis
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2009-11-23
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28
timeFrame: 28 days
measure: Number of Participants in Each Treatment Group With Treatment Success for the Target Lesion (Total Lesion Severity Scale (TLSS) a Score of 0 or 1).
timeFrame: Day 28
Secondary outcomes:
measure: Mean Change From Baseline in PGA Score at Day 28 Using the ITT
timeFrame: Day 28
measure: Mean Change From Baseline in Total Lesion Severity Score (TLSS) at Day 28
timeFrame: Day 28
measure: Mean Change From Baseline in %Body Surface Area (%BSA) Affected at Day 28 (or Early Termination).
timeFrame: Day 28
Other outcomes:
Locations:
city: Miami
country: United States
facility: Investigator Site
state: Florida
city: Martinez
country: United States
facility: Investigator Site
state: Georgia
city: Olathe
country: United States
facility: Investigator Site
state: Kansas
city: Wichita
country: United States
facility: Investigator Site
state: Kansas
city: Albuquerque
country: United States
facility: Investigator Site
state: New Mexico
city: Cincinnati
country: United States
facility: Investigator Site
state: Ohio
city: Simpsonville
country: United States
facility: Investigator Site
state: South Carolina
Study officials:
References: