Effects of Desoximetasone Spray 0.25% on Moderate to Severe Plaque Psoriasis
|Psoriasis||Drug: Desoximetasone Spray 0.25% Drug: placebo comparator||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
|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|
- Clinical Success [ Time Frame: 28 days ]A patient is considered a Clinical Success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear).
- Treatment Success [ Time Frame: 28 days ]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 of each of the three signs and symptoms (erythema, scaling and plaque elevation).
- Mean Change From Baseline in Physician Global Assessment (PGA) Score at Day 28 Using ITT. [ Time Frame: Baseline and day 28 ]
In the Physician Global Assessment of psoriasis is a score based on physician assessment of overall disease severity for all lesions assessed at baseline and at Day 28. The PGA score range: from 0 (Clear=No Psoriatic lesions, i.e. no plaque formation; no erythema, no induration, no scaling) to 5 (Very Severe=Coarse scaling with pronounced cracking and fissures. Erythema is dark red with induration. Plaques are markedly elevated with sharp and hard edges).
The first evaluation was for the change from baseline in PGA, using a two-sided, α = 0.05 level of significance. If superiority of the test product over its vehicle was demonstrated (p<0.05), then PGA change from baseline values was examined.
- Mean Change From Baseline in Total Lesion Severity Scale (TLSS) (ITT) [ Time Frame: Baseline and day 28 ]
Mean Change from Baseline in Lesion Severity Scale-TLSS (ITT)
TLSS of psoriasis is a combined score based on physician assessment of disease severity for the Target Lesion assessed at baseline and at Day 28. The TLSS combined score included summary of individually scored induration (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe), erythema (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe), and scaling (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe). To be eligible for inclusion in the study, the combined score of all three signs for the Target Lesion must total at least 7 and the patient must have at least a score of 3=Moderate for plaque elevation
The first evaluation was for the change from baseline in TLSS, using a two-sided, α = 0.05 level of significance.
- Mean Change From Baseline in Percent Body Surface Area (%BSA) Affected at Day 28 [ Time Frame: Baseline and day 28 ]
Mean Change from Baseline in percent body surface area (%BSA) affected by Psoriasis
The 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
For the %Body Surface Area Affected the "Rule of Nine" was be used.
Change From Baseline in Percent Body Surface Area i.e., difference of base percent values [Percent Body Surface Area at 28 days - Percent Body Surface Area at Baseline].
|Study Start Date:||August 2010|
|Study Completion Date:||January 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Experimental: active product
Desoximetasone Spray 0.25%
Drug: Desoximetasone Spray 0.25%
Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
Other Name: Desoximetasone
Placebo Comparator: placebo comparator
Drug: placebo comparator
Placebo administered to affected area twice a day for 28 days
Other Name: vehicle
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206387
|Study Chair:||Novum Pharmaceutical Research Services||http://www.novumprs.com/contact|