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 range18 Years – 50 Years
SexALL
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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.
Exclusion criteria
✕. 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.