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Efficacy and Safety of Tinefcon^® Tablets in Subjects with Plaque Psoriasis: An Open Label, Non-Comparative, Multicenter, Phase IV Trial

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Journal of Cosmetics, Dermatological Sciences and Applications 2016年第2期6卷 55-66页

作者： Somesh Sharma Kailash Bhatia Meetesh Agarwal Sandesh Gupta Leelavathi Budamakuntla Sudhakar Grandhi Vinod Titarmare Sushil Pande Ranjan Rawal Aruna Samarth Rizwan Haq Vikrant Saoji D. V. S. Pratap L. M. Kansal D. G. Saple Shatrughan Sahay Parag Kalyani puneet goyal Sharmila Patil A. J. Kanwar Bhavesh Swarnakar Sujay Kulkarni Abhijeet Morde Hitesh Khandagale Yogesh Dound Nitin Jadhav Sanjeev Hegde Murlidhara Padigaru Ashish C. Suthar Piramal Enterprises Limited Mumbai India Bhatia Skin Center Bima Nagar Indore India Agrawal Path LAB Vijaynagar Indore India Skin & Laser Center Krishna Nagar New Delhi India Diabetes and Shirdi Skin Care Centre Karnataka India Medipoint Hospitals Pvt. Ltd. Pentagon Research Pvt. Ltd. Pune India Skin Care Clinic Nagpur India NKP Salve Institute and Lata Mangeshkar Hospital Nagpur India Department of Dermatology Sheth VS General Hospital Ahmedabad India Sai Skin Care Clinic Hyderabad India Radiance Skin Care Clinic Nagpur India Dr. Vikrant Saoji’s Clinic Ramdaspeth Nagpur India Durgabai Deshmukh Hospital & Research Center Hyderabad India Kansal Cosmetic & Skin Care Clinic Jaipur India Dr. Saple’s Clinic Dadar (East) Mumbai India Sri Skin Care & Laser Clinic Lucknow UP India Ruby Hall Clinic Pune India Renova Skin & Laser Clinic Sector-9 Mansarovar Jaipur India Dr. D. Y. Patil Medical College and Hospital Nerul Navi Mumbai India Department of Dermatology Venerology & Leprology Postgraduate Institute of Medical Education and Research Chandigarh India Swarnakar Superspeciality Centre Indore India Clinical Research and Development Piramal Enterprises Limited Mumbai India

Importance: This post-marketing surveillance study was conducted to evaluate real-world information about the efficacy and safety of oral Tinefcon? tablets (Sphaeranthus indicus based) in plaque psoriasis patients. Materials and Methods: Patients aged at least 18 years and older with clinical diagnosis of plaque psoriasis, were enrolled in this open label, non-comparative, multicenter trial. All eligible subjects received four 700 mg Tinefcon? tablets/day for 12 weeks. The primary outcome measure was percent change in Psoriasis Area Severity Index (PASI) score from baseline to week 12. The secondary outcome measures were Physician Global Assessment (PGA), Nail Psoriasis Severity Index (NAPSI), Psoriatic Arthritis Evaluation and Gene Expression Profiling and Immunohistochemistry. Results: After completion of Tinefcon? treatment at 12 weeks, more than half of subjects (52%) achieved PASI 50 response;PASI 75 response was attained in 68 (23%) subjects and PASI 90 response in 22 (7%) subjects. Five subjects with severe psoriasis achieved PASI 90 without receiving any concomitant medication. Reduction in severity as assessed by PGA was observed in more than half of patients with moderate disease. Histopathological evaluation revealed that epidermal thickness was considerably reduced in 66% of subjects. The expression of inflammatory marker S100A9 protein was(meaningfully reduced in 60% patients with non-significant reduction of Keratin 10 protein expression. Gene expression analysis showed increase down regulation of SERPINB4;PI3 and KRT16 genes after a 12-week treatment period in subjects with higher PASI scores. Conclusion: Oral Tinefcon? tablets showed good efficacy and had a favorable safety profile in plaque psoriasis patients.

关键词： Psoriasis Tinefcon® Tablet Sphaeranthus indicus

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