MedTrace Logo

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

NCT03514615 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-03-26

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Leicester

    collaborator OTHER

  • Medical Research Council

    collaborator OTHER_GOV

  • University Hospitals, Leicester

    lead OTHER

Principal Investigators

  • Graham Johnston · University of Leicester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-10
Primary Completion
2018-07-20
Completion
2019-07-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03514615 on ClinicalTrials.gov