NCT03514615

A Trial to Assess the Safety and Efficacy of Topical Salbutamol in Healthy Volunteers.

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University Hospitals, Leicester · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This will be a single centre, double-blind, placebo (vehicle) controlled, randomised, dose escalation trial. Three concentrations of topical salbutamol gel will be compared, in a group-wise fashion, with a placebo administration at one incision site on each arm of the trial subjects. Each participant will be allocated to only one dosing group. The treatments will be paired anatomically so that for each pair of sites, one closed incision site will receive the active substance, while the other will receive placebo.

Conditions

• Scarring

Interventions

Type	Name	Description
PROCEDURE	Incision	A skin incision will be made on the medial aspect of the upper arm.
DRUG	Active gel	The incision site on one arm will be dosed with the active gel.
DRUG	Placebo gel	The incision site on the other arm will be dosed with placebo gel.

Timeline

• Start date: 2018-01-10
• Primary completion: 2018-07-20
• Completion: 2019-07-01
• First posted: 2018-05-02
• Last updated: 2020-03-26

Locations

1 site across 1 country: United Kingdom