A Phase IV Clinical Trial to Study the Safety, Tolerability and Efficacy of Tinefcon in Patients With Plaque Psoriasis

Summary

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.

Conditions

• Plaque Psoriasis

Interventions

DRUG

TINEFCON

Two 700 mg tablets of Tinefcon in the morning and evening to be taken orally.

Sponsors & Collaborators

• Piramal Enterprises Limited

  lead INDUSTRY

Principal Investigators

• Dr. Sharmila Patil · D.Y.Patil Medical college and Hospital, Dept. of Dermatology & STD,Sector-5, Nerul, Navi Mumbai

• Dr. Jerajani · Lokmanya Tilak Municipal Medical College & General Hospital, Department of Dermatology, First Floor, College Building,Sion, Mumbai-400022 India

• Dr. Saple · Dr. Saple's clinic, 88, 3rd Lane, Hindu Colony, Near Bhagini Samaj, Dadar (East), Mumbai-400014

• Dr.Ranjan Rawal · Sheth VS General Hospital, Department of Dermatology, Ellis Bridge, Ahmedabad -380006, Gujrat, India

• Dr Sudhakar Grandhi · Medipoint Hospitals Pvt. Ltd.,Pentagon Research Pvt. Ltd, 241/1, New DP Road, Aundh, Pune-411007, Maharashtra

• Dr Sushil Pande · NKP Salve Institute and Lata Mangeshkar Hospital,Nagpur

• Dr. Torsekar · Rajiv Gandhi Medical College & CSMH,Department of Dermatology, Kalwa, Thane

• Dr. C.R. Srinivas · PSG Hospital,Department of Skin & STD,Avinashi Road, Peelamedu, Coimbatore, Tamilnadu-641004

• Dr. DVS Pratap · Durgabai Deshmukh Hospital & Research Center, Andhramahila Sabha Road, Vidyanagar, University Road,Hyderabad

• Dr. Aruna Samarth · Sai Skin Care Clinic, H.No.:2-1-409, Nallakunta, O.U.Road, Hyderabad

• Dr. Kanwar · Postgraduate Institute of Medical Education and Research,Department of Dermatology ,Venerology & Leprology,Sector-12-Chandigarh

• Dr. Meetesh Agarwal · 178/DH Sector, Scheme No. 74, Vijaynagar, Indore 452 2010

• Dr. Kailash Bhatia · Bhatia Skin Center,124-128, Anand Bazar, Bima Nagar, Indore

• Dr. Parmjit Singh Walia · DR WALIA'S SKIN & LASER CLINIC, SCF - 30, PHASE

• Dr. Bhavesh Swarnkar · Swarnkar Superspeciality Centre,84,Shreenagar Main,Regency Avenue,Ground Floor, Near Anand Bazar,Indore

• Dr. Sandesh Gupta · Skin & Laser Center,F-12/10 Krishna Nagar, New Delhi

• Dr. Puneet Goyal · Renova Skin & Laser Clinic,Sector 9, Shopping Centre,Opposite Meera Marg, Madhyam Marg, Mansarovar, Jaipur

• Dr.Rizwan Haq · Radiance Skin Care Clinic, Opp. Muslim Library,Tekdi Road, Sadar, Nagpur

• Dr Vikrant Saoji · Navprabhat Chambers,Opp. Tarun Bharat,Central Bazar Road,Ramdaspeth, Nagpur

• Dr.B. Leelavathy · M.S. Diabetes and Shirdi Skin care centre 6/1, 80 Feet Road, Opp. Krishna Sagar Hotel, Indiranagar, Bangalore

• Dr Titarmare · Skin Care Clinic, Consultant Dermatologist &Venerologist,Akshay Towers(Basement), Umrer Road,Sakkardhara Square, Nagpur

• Dr Shatrughan Sahay · Sri Skin Care & Laser Clinic,Netaji Subash Chandra Bose Complex, Tulsidas Marg (Opp. Charak Pathalogy) Chowk-Lucknow

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-12-31

Primary Completion

2012-02-29

Completion

2012-06-30

Countries

• India

Study Locations