A randomized, assessor blind, parallel group, three arms, active and placebo controlled study with objective to demonstrate therapeutic non-inferiority of AKP02 cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO) versus Enstilar cutaneous foam (calcipotriol 50 μg/g + betamethasone 0.5 mg/g) in subjects with mild to moderate plaque psoriasis.
Eligible subjects (in total 294) will be randomized in a 3:3:1 fashion to receive AKP02 cutaneous spray, Enstilar cutaneous foam or the AKVANO vehicle spray, respectively. The randomization will be stratified by skin type (Fitzpatrick skin type I-III and Fitzpatrick skin type IV-VI). At least 25 % of the subjects randomized in the study should belong to Fitzpatrick skin type I-III and at least 25 % to Fitzpatrick skin type IV-VI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
294
Topical cutaneous spray
Placebo cutaneous spray
Lotus Multispeciality Hospital
Ahmedabad, India
RECRUITINGPercentage change in Psoriasis Area and Severity Index (PASI) score
Percentage change in Psoriasis Area and Severity Index (PASI) score from baseline/randomization to the end of treatment between test product (AKP02 cutaneous spray) and comparator product (Enstilar cutaneous foam). High score is worse
Time frame: From baseline/randomization to Week 4 (Day 29±4)
Percentage change in Psoriasis Scalp Severity Index (PSSI) scores
Percentage change in Psoriasis Scalp Severity Index (PSSI) scores from baseline to end of treatment. High score is worse
Time frame: From date of randomization until Week 4 (Day 29±4) post-randomization
Change in Physician's global assessment (PGA)
Change in Physician's global assessment (PGA) at end of treatment compared to baseline High score is worse
Time frame: From date of randomization until Week 4 (Day 29±4) post-randomization
Change in Scalp Physician's global assessment (ScPGA)
Change in Scalp Physician's global assessment (ScPGA) at end of treatment compared to baseline High score is worse
Time frame: From date of randomization until Week 4 (Day 29±4) post-randomization
Frequency of adverse events and serious adverse events
Frequency of adverse events and serious adverse events or any event of clinical significance
Time frame: From date of randomization until end of study
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