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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
151
Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days
Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days
Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days
Investigator Site
Miami, Florida, United States
Investigator Site
Martinez, Georgia, United States
Investigator Site
Olathe, Kansas, United States
Investigator Site
Wichita, Kansas, United States
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
Time frame: 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.
Time frame: Day 28
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.
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Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days
Vehicle topical spray administered to affected areas once daily for 28 days
Vehicle topical spray administered to affected areas twice daily for 28 days
Investigator Site
Albuquerque, New Mexico, United States
Investigator Site
Cincinnati, Ohio, United States
Investigator Site
Simpsonville, South Carolina, United States
Time frame: 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.
Time frame: 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.
Time frame: Day 28