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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
A skin incision will be made on the medial aspect of the upper arm.
The incision site on one arm will be dosed with the active gel.
The incision site on the other arm will be dosed with placebo gel.
Leicester Royal Infirmary
Leicester, United Kingdom
Peak plasma concentration
The primary trial endpoint will be the peak plasma concentration of salbutamol at day 0.
Time frame: 24 hours
Peak Plasma concentration 2
The peak plasma concentration of salbutamol at day 10.
Time frame: 10 days
Efficacy of treatment using the Global Scar Comparison Scale
Improvement in scar appearance will be assessed using a global appearance scale, referred to as the "Global Scar Comparison Scale" (GSCS), which seeks to assess which one of a pair of scars is visually improved compared to the other. The scale is based on a 200mm Visual Analogue Scale, with "0"mm at the centre indicating no difference between the scars. The extremes of the scale -100mm to +100mm are reserved for one scar becoming imperceptible compared to the other. The assessment will be performed by both the patient and investigator independently at months 7, 9 and 12.
Time frame: 12 months
Efficacy of treatment using the Patient Observer Scar Assessment Scale
Improvement in scar appearance will be assessed using the "Patient and Observer Scar Assessment Scale" (POSAS) which is a composite scale made up of sub-scales, that measure 12 items numerically (6 by the patient; scar pain, scar itch, colour differences, scar stiffness, scar thickness and scar irregularity) and six items scored by the investigator (vascularity, pigmentation, thickness, relief, pliability and surface area). The patient sub-scales are scored 1-10 where 1="no, not at all" and 10 = "yes, very much". The clinical sub-scores are also scored 1-10 with 1=normal skin and 10=worst scar imaginable. POSAS is calculated as a total score of all sub-scores. The assessment will be performed by both the patient and investigator independently at months 7, 9 and 12.
Time frame: 12 months
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