Health Condition 1: L400- Psoriasis vulgaris
Conditions
Sponsors
Ms PURE CARE HEALTHCARE PVT LTD
Ms PURE CARE HEALTHCARE PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: Subjects meeting the following criteria will be included in the study: 1. Male or female subjects aged 12 years or older, inclusive. 2. Clinical diagnosis of psoriasis vulgaris of at least 6 months duration, as determined by the Investigator. 3. Females of childbearing potential must have a negative pregnancy test at Screening Visit 1 and Baseline Visit 2. In addition, sexually active females of childbearing potential must agree to use at least one form of highly effective contraception throughout the trial. 4. In good health as judged by the Investigator, based on medical history, physical examination, biochemistry laboratory tests, haematology values, and urinalysis. 5. Subjects considered reliable and capable of adhering to the Protocol and visit schedule.
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study for any of the following reasons: 1. Subjects with severe plaque psoriasis defined as an Investigator Global Assessment score of 4 at Screening or Baseline, or those requiring immediate systemic therapy as per the Investigator s clinical judgment. 2. Subjects with known severe immunological diseases such as human immunodeficiency virus infection. 3. Any diagnosis of systemic sclerosis. 4. Subjects with current or untreated tuberculosis. 5. Subjects with active viral hepatitis, including hepatitis B or hepatitis C. 6. Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator. 7. Subjects with a history of chronic alcohol or drug abuse within 6 months prior to initiation of the investigational product. 8. Subjects with a current or past history of malignancy, with the exception of adequately treated basal cell carcinoma. 9. Subjects who have used topical prescription treatments for psoriasis within 2 weeks prior to randomization or who plan to use them during the study period. 10. Subjects who are currently receiving treatment with systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously, including erythromycin, ketoconazole, fluvoxamine, enoxacin, and cimetidine. 11. Subjects with a confirmed pregnancy at Screening or Baseline. 12. Subjects who plan to become pregnant within 6 months of study entry. 13. Subjects who are currently breastfeeding. 14. Subjects who plan to donate blood at any time during the study. 15. Subjects who are, in the Investigator s opinion, unable or unlikely to complete the study or comply with the Protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy profile of Roflumilast 0.3% cream versus Calcipotriol 5 mcg cream in patient with Plaque Psoriasis.Timepoint: At Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety profile of Roflumilast 0.3% cream Versus Calcipotriol 5 mcg cream, in patients with Plaque Psoriasis. To explore histopathological changes in psoriatic lesions following treatment with Roflumilast 0.3% cream versus Calcipotriol 5 mcg cream in a limited subset of subjects (i,e 30 patients in total in both the arms) undergoing skin biopsyTimepoint: Week 04, Week 08, Week 12 & Week 16. | — |
Countries
India
Contacts
Public ContactKamlesh Londhe
Vivotech Research Private Limited
Outcome results
None listed