Desoximetasone Spray 0.05%, 0.25%; Dose Ranging Study

Study Overview
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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.

Official Title
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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

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Desoximetasone 0.05% once daily
* Drug: Desoximetasone 0.05% twice daily
* Drug: Desoximetasone 0.25% once daily
* Drug: Desoximetasone 0.25% once daily
* Drug: Vehicle once daily
* Drug: Vehicle twice daily


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desoximetasone 0.05% once daily<br>Desoximetasone topical spray 0.05% administered once daily to affected area | Drug: Desoximetasone 0.05% once daily<br>* Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days<br>|
| Experimental: Desoximetasone 0.05% twice daily<br>Desoximetasone topical spray 0.05% administered twice daily to affected area | Drug: Desoximetasone 0.05% twice daily<br>* Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days<br>|
| Experimental: Desoximetasone 0.25% once daily<br>Desoximetasone topical spray 0.25% administered once daily to affected area | Drug: Desoximetasone 0.25% once daily<br>* Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days<br>|
| Experimental: Desoximetasone 0.25% twice daily<br>Desoximetasone topical spray 0.25% administered twice daily to affected area | Drug: Desoximetasone 0.25% once daily<br>* Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days<br>|
| Placebo Comparator: Vehicle once daily<br>Vehicle administered to affected areas once daily | Drug: Vehicle once daily<br>* Vehicle topical spray administered to affected areas once daily for 28 days<br>|
| Placebo Comparator: Vehicle twice daily<br>Vehicle administered to affected areas twice daily | Drug: Vehicle twice daily<br>* Vehicle topical spray administered to affected areas twice daily for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28 | The primary endpoint was the proportion of patients in each treatment group who were considered a Clinical Success (PGA score of 0 or 1) at Day 28 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation) The primary measure of efficacy was evaluated using those patients eligible for inclusion in the ITT population. On a seven point grade PGA scale a patient will be considered a Clinical Success if: the patient's PGA score is 0 or 1. A score of 0 = Clear or 1= Almost Clear was considered clinical success. A patient will be considered a Clinical Failure if: the patient's PGA score is > 1, the patient was considered to have an insufficient therapeutic response | 28 days | 
| 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). | The proportion of patients in each treatment group who were considered a Treatment Success for the target lesion (a score of 0 or 1 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation)) at Day 28. Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components. A TLS score of 0 = Clear or 1= Almost Clear was considered treatment success. | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in PGA Score at Day 28 Using the ITT | Physician Global Assessment (PGA) of Psoriasis is scored 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 plaque formation, induration, erythema, and scaling; range: 0 (clear) to 5 (very severe). The severity score was summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe; 5=very severe). PGA response was defined as 0 (clear) or 1 (almost clear) Higher scores indicate greater severity of disease. | Day 28 | 
| Mean Change From Baseline in Total Lesion Severity Score (TLSS) at Day 28 | Each lesion was evaluated for 3 components: erythema, plaque elevation, and scaling. Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components. | Day 28 | 
| Mean Change From Baseline in %Body Surface Area (%BSA) Affected at Day 28 (or Early Termination). | Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis. BSA = SQRT ((height (cm) X weight (kg))/3600) BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared %Body Surface Area Affected the Rule of Nine was be used. | Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, Topical corticosteroids, Plaque psoriasis