Investigate antipruritic effects of SB-705498

• Research type

  Research Study

• Full title

  A two part randomized, double-blind placebo controlled study to investigate the effect of topical, single doses of SB-705498 on capsaicin, histamine, and cowhage responses in healthy volunteers

• IRAS ID

  100362

• Contact name

  Disala Fernando

• Eudract number

  2012-000182-20

• ISRCTN Number

  ISRCTN

• Research summary

  This experimental medicine study in two parts investigates the anti itch properties of a cream containing SB705498. The results will help to design future studies for patients with eczema. SB705498 blocks some of the systems in the body that are involved in pain, allergy and itch. It has been well tolerated in previous research studies as a painkiller tablet, at doses up to 1000 mg, and as a nasal spray for nasal congestion such as hayfever. Part A will be conducted in 16 healthy volunteers who will receive 1%, 3% and 5% of SB705498 containing cream or placebo (cream without the active ingredient) in a random order applied to separate areas of skin on both forearms, followed by capsaicin cream (capsaicin is the active component of chilli peppers). A special camera called Laser Doppler Imaging (LDI) will measure the flare (skin redness) that develops following the capsaicin cream. The strength of SB705498 cream that causes greatest reduction in flare will be selected for part B of the study. Part B will be conducted in 10 volunteers selected according to their LDI results in Part A and will assess the reduction of itch by SB705498 cream following 2 agents: (1) Cowhage spicules (tip of the tropical cowhage plant??s seed pod hairs, which causes itch and often used as an ingredient in itching powder), and (2) Histamine (a chemical produced in the body during an allergic reaction). Itch intensity will be rated on a numerical scale from 0 to 100 using a computer. During part A or B, volunteers will undergo screening session for eligibility, two study days on an outpatient basis in the unit and a 1 day follow up visit. The study will be conducted in a specialist clinical research unit with adequate facilities with regard to safety and compliance.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  12/LO/0841

• Date of REC Opinion

  6 Jun 2012

• REC opinion

  Favourable Opinion