A Trial to Assess the Safety and Efficacy of Topical Salbutamol in Healthy Volunteers. (NCT03514615) | Clinical Trial Compass
CompletedPhase 1
A Trial to Assess the Safety and Efficacy of Topical Salbutamol in Healthy Volunteers.
United Kingdom45 participantsStarted 2018-01-10
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Able, in the opinion of the investigator, and willing to give informed consent
. Aged 18 - 50 inclusive, with both arms
. Participants registered on The Over Volunteering Prevention System (TOPS) or equivalent in Leicester.
. Body mass index within the range 15.0-35.0 kg/m2. Inclusive (i.e. ≥ 15.0 and ≤ 35.0)
. In the opinion of the investigator, clinically acceptable results for the laboratory tests specified in the trial protocol (see Protocol Section 11.2). All laboratory tests must be performed within 28 days of the subject's first trial dose administration.
. Women of child bearing potential (WOCBP) must be using a highly effective means of contraception and agree to do so from at least the screening visit until trial end or completion of the trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. On direct questioning, have evidence of Left/Right Confusion.
. On direct questioning and/or physical examination a history or evidence of keloid scarring.
. On direct questioning have a family history of keloid scarring.
. Tattoos or previous scars within 3cm of the area to be incised during the trial.
. Surgery in the area to be incised and have surgical scars within 3cm of this area.
. History of a bleeding disorder or who are receiving anti-coagulant or anti-platelet therapy.
. On direct questioning and physical examination, have evidence of any past or present clinically significant disease that may affect the endpoints of the trial. For example: Coagulation disorders, diabetes, immuno-mediated conditions or allergies (including allergic contact dermatitis).
. Subjects with a clinically significant skin disorder (dermatitis, eczema, psoriasis) that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial.