Back to resultsEffects of Desoximetasone Spray 0.25% in Patients With Moderate to Severe Plaque Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Desoximetasone Spray 0.25%
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
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.
Sites / Locations
- Investigator Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Desoximetasone Spray 0.25%
placebo
Arm Description
Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
Placebo administered to affected area twice a day for 28 days
Outcomes
Primary Outcome Measures
Clinical Success ITT
A patient is considered a Clinical Success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear).
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01206660
First Posted
September 20, 2010
Last Updated
June 3, 2014
Sponsor
Taro Pharmaceuticals USA
1. Study Identification
Unique Protocol Identification Number
NCT01206660
Brief Title
Effects of Desoximetasone Spray 0.25% in Patients With Moderate to Severe Plaque Psoriasis
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taro Pharmaceuticals USA
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Desoximetasone Spray 0.25%
Arm Type
Experimental
Arm Description
Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered to affected area twice a day for 28 days
Intervention Type
Drug
Intervention Name(s)
Desoximetasone Spray 0.25%
Intervention Description
Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo administered to affected area twice a day for 28 days
Primary Outcome Measure Information:
Title
Clinical Success ITT
Description
A patient is considered a Clinical Success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear).
Time Frame
28 days
Title
Treatment Success
Description
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).
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Physician's Global Assessment (PGA) of Psoriasis Score at Day 28.
Description
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.
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Investigator Site
City
Hazleton
State/Province
Pennsylvania
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of Desoximetasone Spray 0.25% in Patients With Moderate to Severe Plaque Psoriasis
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