A prospective, open-label, non-randomised clinical trial to evaluate the safety and efficacy of Imupsora in the treatment of Psoriasis

Abstract

Objectives: To evaluate the clinical efficacy and safety of Imupsora Tablet and Ointment in Psoriasis. Material and Methods: A prospective, interventional clinical study was conducted on 50 patients of both sexes, aged between 18-55 years, confirmed with Psoriasis from clinical examination and who were willing to give informed consent. All patients received Imupsora Tablet at a dose of 2 tablets twice a day for 12 weeks and Imupsora Ointment to be applied over the affected areas thrice daily as a thin film and rubbed gently. All patients were evaluated at baseline, 4 weeks, 8 weeks and 12 weeks for parameters of Psoriasis Area Severity Index (PASI); Physician's and Patient's global assessment at end of the study. Observation: Imupsora Tablet and Ointment therapy reduced erythema, scaling, indurations and pruritus by 78.01%, 69.74%, 58.45%, and 56.80% respectively at the end of 12 weeks from baseline. The global assessment of response by physicians showed that 28% of patients showed a good improvement while another 60% showed fair improvement in their condition by the end of 12 weeks of treatment. Similarly, 46% and 42% of the patient's global assessment indicated fair and good response at the end of treatment respectively. Result: Imupsora Tablet and Ointment produced a significant reduction in all the inflammatory/metabolic parameters associated with Psoriasis assessed after 12 weeks of treatment. In addition, a significant improvement in Clinical Global Impression in efficacy and tolerability was also observed. No adverse events were reported by any patients. This indicates that Imupsora Tablet and Ointment is clinically effective and safe for Psoriasis.