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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AKP02 | Experimental | cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO) |
|
| Enstilar | Active Comparator | cutaneous foam (calcipotriol 50 μg/g + betamethasone 0.5 mg/g) |
|
| Placebo | Placebo Comparator | cutaneous spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AKP02/AKVANO cutaneous spray (calcipotriol 50 μg/g + betamethasone 0.5 mg/g/ AKVANO) | Drug | Topical cutaneous spray |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage 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 | From baseline/randomization to Week 4 (Day 29±4) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From date of randomization until Week 4 (Day 29±4) post-randomization |
| Change in Physician's global assessment (PGA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Klockare | Contact | +46706232505 | maria.klockare@lipidor.se |
| Name | Affiliation | Role |
|---|---|---|
| Maria Klockare, PhD | Lipidor AB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lotus Multispeciality Hospital | Recruiting | Ahmedabad | India |
A CSR will be provide to all Investigators
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| ID | Term |
|---|---|
| C055085 | calcipotriene |
| D001623 | Betamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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A randomized, assessor blind, parallel group, three arms, active and placebo controlled study
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| Enstilar Topical Product (calcipotriol 50 μg/g + betamethasone 0.5 mg/g) | Drug | Topical foam |
|
| Placebo | Other | Placebo cutaneous spray |
|
Change in Physician's global assessment (PGA) at end of treatment compared to baseline High score is worse |
| 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 | 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 | From date of randomization until end of study |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |