The purpose of this study is to compare the efficacy and safety of Calcipotriol 50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension with the active components when used individually as monotherapy in the topical suspension vehicle (betamethasone dipropionate in the topical suspension vehicle, calcipotriol in the topical suspension vehicle) and with the topical suspension vehicle alone in the treatment of psoriasis vulgaris on the non-scalp regions of the body (trunk and/or limbs) in a large phase 3 study. This comparison will ensure a more informed assessment of the benefit/risk ratio of Calcipotriol 50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension while also establishing the optimal treatment duration in psoriasis vulgaris on the non-scalp regions of the body (trunk and/or limbs).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,152
Topical suspension once daily for up to 8 weeks.
Topical suspension once daily for up to 8 weeks.
Topical suspension once daily for up to 8 weeks.
Topical suspension once daily for up to 8 weeks.
Horizon Research Group, Inc
Mobile, Alabama, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Advanced Clinical Research Institute
Anaheim, California, United States
DBA Torrance Clinical Research
Lomita, California, United States
Dermatology Specialists, Inc.
Oceanside, California, United States
Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 4
The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with 'Controlled disease' according to the IGA. 'Controlled disease' is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.
Time frame: 4 weeks
Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 8
The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with 'Controlled disease' according to the IGA. 'Controlled disease' is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.
Time frame: week 8
Mean Percentage Change in PASI From Baseline to Week 4
At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject's psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.
Time frame: Baseline and 4 weeks
Mean Percentage Change in PASI From Baseline to Week 8
At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject's psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.
Time frame: Baseline and 8 weeks
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Skin Surgery Medical Group, Inc.
San Diego, California, United States
Walter Nahm, MD, Ph.D., Inc
San Diego, California, United States
Coastal Medical Research Group, Inc.
San Luis Obispo, California, United States
Clinical Science Institute
Santa Monica, California, United States
Dermatology Research Centers
Santa Monica, California, United States
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