This study will compare the efficacy and safety of once daily treatment of LEO 19123 cream versus Dovonex® cream (applied twice daily) and versus LEO 19123 cream vehicle alone (applied twice daily) in subjects with psoriasis vulgaris. Subject will be treated for 4 weeks. All subjects will apply LEO 19123 cream to psoriasis lesions on the left or right side of the body and either Dovonex® cream or cream vehicle to lesions on the other side.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
51
Once daily application
Twice daily application
Twice daily application
UltraNova Skincare
Barrie, Ontario, Canada
The Percentage Change in PASI (Psoriasis Area Severity Index)
The following formula was used to calculate the PASI for each side of the body: Upper extremities: 0.2 (R + T+ S) E = X Trunk: 0.3 (R + T+ S) E = Y Lower extremities 0.4 (R + T+ S) E = Z where: R = score for redness T = score for thickness S = score for scaliness E = score for extent The sum of X + Y + Z gives the total PASI, which can range from 0 to 64.8. The PASI used in this study is modified to exclude assessment of the head, as study treatment was not used here.
Time frame: From baseline (Day 0) to end of treatment (Day 28)
Investigator's Global Assessment of Disease Severity
At all visits the (sub)investigator made a global assessment of the disease severity for psoriasis on the left and right side, respectively, of the body by use of the 6-point scale below. These assessments were to represent the average lesion severity on the left and right side, respectively. These assessments were to be based on the condition of the disease at the time of evaluation, and not in relation to the condition at a previous visit. Clear Almost clear Mild Moderate Severe Very severe
Time frame: At end of treatment (Day 28)
Participants With "Controlled Disease" According to the Investigator's Global Assessment of Disease Severity
For subjects with a baseline (Visit 1) severity of moderate or worse, "controlled disease" is defined as "clear" or "almost clear" according to the Investigator's global assessment of disease severity. For subjects with a baseline (Visit 1) severity of mild, "controlled disease" is defined as "clear" according to the Investigator's global assessment of disease severity.
Time frame: At end of treatment (Day 28)
Participant's Overall Assessment of Treatment Response
The participant assessed the treatment response by use of the 6-point scale below. Worse Unchanged Slight improvement Moderate improvement Marked improvement Almost clear Cleared
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Time frame: At end of treatment (Day 28)
Participant's Assessment of Treatment Preference
Time frame: At end of treatment (Day 28)
Participants With at Least 75% Reduction in PASI (PASI 75)
Time frame: From baseline (Day 0) to end of treatment (Day 28)
Participants With at Least 50% Reduction in PASI (PASI 50)
Time frame: From baseline (Day 0) to end of treatment (day 28)
The Absolute Change in PASI (Psoriasis Area Severity Index)
The following formula was used to calculate the PASI for each side of the body: Upper extremities: 0.2 (R + T+ S) E = X Trunk: 0.3 (R + T+ S) E = Y Lower extremities 0.4 (R + T+ S) E = Z where: R = score for redness T = score for thickness S = score for scaliness E = score for extent The sum of X + Y + Z gives the total PASI, which can range from 0 to 64.8. The PASI used in this study is modified to exclude assessment of the head, as study treatment was not used here.
Time frame: From baseline to end of treatment (Day 28)