CT327 in Patients with Stable Psoriasis Vulgaris

• Research type

  Research Study

• Full title

  A Randomised, Placebo-controlled Phase I Study to Evaluate the Safety and Tolerability of 0.5% w/w CT327 when Applied Twice Daily to Stable Psoriasis Vulgaris Patients’ Skin Lesions

• IRAS ID

  78399

• Sponsor organisation

  Creabilis

• Eudract number

  2011-001136-36

• ISRCTN Number

  N/A

• Research summary

  The investigational study drug CT327 is being developed by the sponsor, Creabilis S.A. as an ointment that may have potential as a treatment for psoriasis. The aim of the study is to understand how this new formulation behaves when it is applied over a one week period to skin that has been affected by psoriasis. We will do this by testing how much of the drug can be found in the bloodstream, and looking closely for any effects that the drug may have had on the skin to which it was applied.On this study patients will be allocated to receive either 0.5% w/w CT327 ointment (12 volunteers) or a placebo ointment that looks identical, but does not contain any drug (4 volunteers). The order in which volunteers will be allocated to treatments is random. Patients will be expected to attend for 3 visits in total over a period of approximately 6 weeks. The first visit is screening. On the second study visit patients will be admitted to the clinic on the evening before the study starts (Day -1). Patients will be resident throughout the period of dosing and will be discharged on the morning of study day 8. The final study visit occurs 7 to 10 days after the last dose of study drug.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  11/NE/0086

• Date of REC Opinion

  18 May 2011

• REC opinion

  Further Information Favourable Opinion