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Psoriasis is a chronic inflammatory hyperproliferative disease of the skin affecting approximately 2% of the world's population.This phase IV study is planned to monitor performance of Tinefcon in patients suffering from psoriasis under conditions of actual use and fulfill requirements to monitor all adverse drug reactions (ADRs) in psoriasis patients treated with Tinefcon. This study will add to literature on the risks and benefits of Tinefcon the novel oral TNF-alpha release inhibitor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TINEFCON | Experimental | Tablets of 700 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TINEFCON | Drug | Two 700 mg tablets of Tinefcon in the morning and evening to be taken orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Psoriasis area severity index score | Change from baseline at week 4, week 8 and week 12 or early termination | At week 4, week 8 and week 12 or early termination |
| Measure | Description | Time Frame |
|---|---|---|
| Gene expression profiling and Immunohistochemistry | At baseline and week 12 or early termination | |
| Physicians global assessment score | At week 4, week 8 and week 12 / early termination visit | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Sharmila Patil | D.Y.Patil Medical college and Hospital, Dept. of Dermatology & STD,Sector-5, Nerul, Navi Mumbai | Principal Investigator |
| Dr. Jerajani | Lokmanya Tilak Municipal Medical College & General Hospital, Department of Dermatology, First Floor, College Building,Sion, Mumbai-400022 India | Principal Investigator |
| Dr. Saple | Dr. Saple's clinic, 88, 3rd Lane, Hindu Colony, Near Bhagini Samaj, Dadar (East), Mumbai-400014 | Principal Investigator |
| Dr.Ranjan Rawal | Sheth VS General Hospital, Department of Dermatology, Ellis Bridge, Ahmedabad -380006, Gujrat, India | Principal Investigator |
| Dr Sudhakar Grandhi | Medipoint Hospitals Pvt. Ltd.,Pentagon Research Pvt. Ltd, 241/1, New DP Road, Aundh, Pune-411007, Maharashtra | Principal Investigator |
| Dr Sushil Pande | NKP Salve Institute and Lata Mangeshkar Hospital,Nagpur | Principal Investigator |
| Dr. Torsekar | Rajiv Gandhi Medical College & CSMH,Department of Dermatology, Kalwa, Thane | Principal Investigator |
| Dr. C.R. Srinivas | PSG Hospital,Department of Skin & STD,Avinashi Road, Peelamedu, Coimbatore, Tamilnadu-641004 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durgabai Deshmukh Hospital & Research Center | Hyderabad | Andhra Pradesh | India | |||
| Postgraduate Institute of Medical Education and Research,Department of Dermatology ,Venerology & Leprology |
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| Nail psoriasis severity index |
| At baseline and at week 12 or early termination |
| Psoritic arthritis evaluation | At baseline and week 12 or early termination |
| Principal Investigator |
| Dr. DVS Pratap | Durgabai Deshmukh Hospital & Research Center, Andhramahila Sabha Road, Vidyanagar, University Road,Hyderabad | Principal Investigator |
| Dr. Aruna Samarth | Sai Skin Care Clinic, H.No.:2-1-409, Nallakunta, O.U.Road, Hyderabad | Principal Investigator |
| Dr. Kanwar | Postgraduate Institute of Medical Education and Research,Department of Dermatology ,Venerology & Leprology,Sector-12-Chandigarh | Principal Investigator |
| Dr. Meetesh Agarwal | 178/DH Sector, Scheme No. 74, Vijaynagar, Indore 452 2010 | Principal Investigator |
| Dr. Kailash Bhatia | Bhatia Skin Center,124-128, Anand Bazar, Bima Nagar, Indore | Principal Investigator |
| Dr. Parmjit Singh Walia | DR WALIA'S SKIN & LASER CLINIC, SCF - 30, PHASE | Principal Investigator |
| Dr. Bhavesh Swarnkar | Swarnkar Superspeciality Centre,84,Shreenagar Main,Regency Avenue,Ground Floor, Near Anand Bazar,Indore | Principal Investigator |
| Dr. Sandesh Gupta | Skin & Laser Center,F-12/10 Krishna Nagar, New Delhi | Principal Investigator |
| Dr. Puneet Goyal | Renova Skin & Laser Clinic,Sector 9, Shopping Centre,Opposite Meera Marg, Madhyam Marg, Mansarovar, Jaipur | Principal Investigator |
| Dr.Rizwan Haq | Radiance Skin Care Clinic, Opp. Muslim Library,Tekdi Road, Sadar, Nagpur | Principal Investigator |
| Dr Vikrant Saoji | Navprabhat Chambers,Opp. Tarun Bharat,Central Bazar Road,Ramdaspeth, Nagpur | Principal Investigator |
| Dr.B. Leelavathy | M.S. Diabetes and Shirdi Skin care centre 6/1, 80 Feet Road, Opp. Krishna Sagar Hotel, Indiranagar, Bangalore | Principal Investigator |
| Dr Titarmare | Skin Care Clinic, Consultant Dermatologist &Venerologist,Akshay Towers(Basement), Umrer Road,Sakkardhara Square, Nagpur | Principal Investigator |
| Dr Shatrughan Sahay | Sri Skin Care & Laser Clinic,Netaji Subash Chandra Bose Complex, Tulsidas Marg (Opp. Charak Pathalogy) Chowk-Lucknow | Principal Investigator |
| Chandigarh |
| Chandigarh |
| India |
| Sheth VS General Hospital, Department of Dermatology | Ahmedabad | Gujarat | India |
| M.S. Diabetes and Shirdi Skin care centre | Bangalore | Karnataka | India |
| Bhatia Skin Center,124-128, Anand Bazar, Bima Nagar | Indore | Madhtya Pradesh | 452001 | India |
| Scheme No. 74, , Vijaynagar, , | Indore | Madhya Pradesh | India |
| Swarnkar Superspeciality Centre,84,Shreenagar Main,Regency Avenue,Ground Floor, Near Anand Bazar | Indore | Madhya Pradesh | India |
| Sai Skin Care Clinic | Hyderabad | Maharashtra | India |
| Dr. Saple's clinic | Mumbai | Maharashtra | India |
| Lokmanya Tilak Municipal Medical College & General Hospital, Department of Dermatology, First Floor, College Building,Sion | Mumbai | Maharashtra | India |
| Seth GS Medical College &KEM Hospital,Department of Dermatology | Mumbai | Maharashtra | India |
| Dr.Vikrant Saoji,27, Navprabhat Chambers,Opp. Tarun Bharat,Central Bazar Road,Ramdaspeth | Nagpur | Maharashtra | India |
| NKP Salve Institute and Lata Mangeshkar Hospital | Nagpur | Maharashtra | India |
| Radiance Skin Care Clinic | Nagpur | Maharashtra | India |
| Skin Care Clinic, Consultant Dermatologist &Venerologist | Nagpur | Maharashtra | India |
| Medipoint Hospitals Pvt. Ltd | Pune | Maharashtra | India |
| Rajiv Gandhi Medical College | Thane | Maharashtra | India |
| Skin & Laser Center,F-12/10 Krishna Nagar, | New Delhi | New Delhi | India |
| Dr Walia'S Skin & Laser Clinic, Scf - 30, Phase- 3B-2, S.A.S. Nagar | Mohali | Punjab | India |
| Renova Skin & Laser Clinic,Sector 9, Shopping Centre,Opposite Meera Marg, Madhyam Marg | Jaipur | Rajasthan | India |
| PSG Hospital,Department of Skin & STD | Coimbatore | Tamil Nadu | India |
| Sri Skin Care & Laser Clinic | Lucknow | Uttar Pradesh | India |
| D.Y.Patil Medical college and Hospital, Dept. of Dermatology & STD,Sector-5, Nerul | Navi Mumbai | India |