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

NCT03514615 | Completed Phase 1 DMC

• 1 other identifier: 97807
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Peak plasma concentration

  The primary trial endpoint will be the peak plasma concentration of salbutamol at day 0.

  24 hours

Secondary Outcomes (3)

• Peak Plasma concentration 2

  10 days

• Efficacy of treatment using the Global Scar Comparison Scale

  12 months

• Efficacy of treatment using the Patient Observer Scar Assessment Scale

  12 months

Study Arms (2)

Placebo Gel

PLACEBO COMPARATOR

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 gel and the other placebo.

Procedure: Incision; Drug: Placebo gel

Active Gel

EXPERIMENTAL

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 gel and the other placebo.

Procedure: Incision; Drug: Active gel

Interventions

Incision PROCEDURE

A skin incision will be made on the medial aspect of the upper arm.

Active Gel; Placebo Gel

Active gel DRUG

The incision site on one arm will be dosed with the active gel.

Active Gel

Placebo gel DRUG

The incision site on the other arm will be dosed with placebo gel.

Placebo Gel

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Any clinically significant medical condition or history that would impair wound healing including:
• Rheumatoid arthritis.
• Chronic renal impairment for their age.
• Hepatic impairment (LFTs \>3 times upper limit of normal).
• Congestive heart failure.
• Pre-existing ischemic heart disease
• Pulmonary hypertension

Sponsors & Collaborators

• University Hospitals, Leicester: lead
• University of Leicester: collaborator
• Medical Research Council: collaborator

Study Sites (1)

Leicester Royal Infirmary

Leicester, United Kingdom

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Graham Johnston

  University of Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: May 2, 2018
• Study Start: January 10, 2018
• Primary Completion: July 20, 2018
• Study Completion: July 1, 2019
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

GB (1)