SSCART

• Research type

  Research Study

• Full title

  A double blind, placebo controlled, randomised dose escalation trial to investigate the safety and efficacy of topical salbutamol in the improvement of scar appearance when applied to approximated wound margins in healthy volunteers. Short title: A trial to assess the safety and efficacy of topical salbutamol in healthy volunteers

• IRAS ID

  222607

• Contact name

  Graham Johnston

• Contact email

  graham.johnston@uhl-tr.nhs.uk

• Sponsor organisation

  University Hospitals of Leicester NHS Trust

• Eudract number

  2017-003118-15

• Duration of Study in the UK

  2 years, 6 months, 15 days

• Research summary

  This is a single centre, double blind, placebo (vehicle) controlled, randomised, dose escalation trial, in which three concentrations of topical salbutamol gel (2.5mM, 5mM and 10mM) will be compared, in a group-wise fashion, with a placebo administration at one 2cm full thickness incision site on each arm of the volunteer subjects. The treatments will be paired anatomically so that for each pair of scars, one closed incision site with receive topical salbutamol and the other placebo. This design allows for the comparison of drug versus placebo within the same patient but without the complications of variations in healing and scarring in different patients and or at different anatomical sites.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  17/EE/0377

• Date of REC Opinion

  31 Oct 2017

• REC opinion

  Further Information Favourable Opinion