Health Condition 1: L400- Psoriasis vulgaris
Conditions
Interventions
Intervention1: AKP02 cutaneous spray (calcipotriol & betamethasone
dipropionate): Topical spray containing calcipotriol & betamethasone, To be applied once daily for 4 weeks
Control Intervention1: Ens
Sponsors
Lipidor AB
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant female subjects aged >18 years with general good health and having either Fitzpatrick skin type Iâ??III or IVâ??VI 2. A clinical diagnosis of stable (at least 6 months) psoriasis vulgaris on body, or body and scalp, involving 5 to 10% of BSA and PASI 3. Mild or moderate Psoriasis on (PGA) score (2 or 3). 4. A plaque elevation of at least moderate severity (grade >= 3) at the target lesion site. 5. Subjects must be willing to provide written informed consent and able to understand and can comply with study requirements
Exclusion criteria
Exclusion criteria: 1. Subject with history of hypersensitivity to betamethasone or calcipotriol or any component of the study medication. 2. Current diagnosis of unstable forms of psoriasis in the treatment area 3. Subjects with diagnosis of mild to moderate psoriasis only in the scalp area. 4. Other inflammatory skin disease in the treatment area 5. Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatment areas, which could interfere with the rating of efficacy parameters. 6. Subject with history of psoriasis unresponsive to topical treatments and in need of systemic treatment 7. Subject with psoriasis lesions predominantly on palms and soles or palmo-plantar psoriasis. 8. Subjects with the diagnosis pustulosis palmo-plantaris 9. Ongoing use of other psoriasis treatment including but not limited to topical or systemic corticosteroids, other topical medications (i.e. coal tar), oral or biologic medications for the treatment of psoriasis, and UV therapy. 10. Use of oral estrogen therapy, excluding oral contraceptive pills 11. Females of childbearing potential not agree to utilize contraception and who are pregnant, nursing, or planning a pregnancy 12. Current significant medical problems that, in the discretion of the investigator, would put the subject at significant risk 13. Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamics half-lives, if known (whichever is longer) 14. Current or past history of hypercalcemia, calcium metabolism disorder, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders. 15. Current immunosuppression and positive for serology tests like HIV, HCV & HBsAg. 16. Use of biologic treatment for psoriasis (e.g., infliximab, adalimumab, alefacept) within six months prior to Baseline. 17. Use of: 1) chemotherapy, or 2) radiation therapy, within three months prior to Baseline. 18. Use of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), or 2) oral retinoids, within two months prior to Baseline. 19. Use of: 1) systemic steroids, 2) systemic antibiotics, 3) other systemic antipsoriatic treatment, 4) PUVA therapy, 5) UVB therapy, or 6) systemic anti-inflammatory agents, within one month prior to Baseline. 20. Use of: 1) topical anti-psoriatic drugs, 2) topical corticosteroids, or 3) topical retinoids, within 2 weeks prior to Baseline. 21. Use of medicated shampoos with possible effect on psoriasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of change in PASI score between AKP02 cutaneous spray and Enstilar cutaneous foamTimepoint: From baseline/randomization to Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Scalp Physicianâ??s global assessment (ScPGA) at end of treatment compared to baseline.Timepoint: At baseline/randomization and Week 4 post-randomization;To evaluate the difference of change in psoriasis severity between AKP02 cutaneous spray and Enstilar cutaneous foam based on PSSI, PGA and ScPGA.Timepoint: From baseline/randomization to Week 4 | — |
Countries
India
Contacts
Public ContactAshish Amarsheda
Cadila Pharmaceuticals Limited
Outcome results
None listed