Overview

Study of PK and Safety of the LicartTM Topical System in Pediatric and Adult Participants With Minor Soft Tissue Injury

Status:
Recruiting
Trial end date:
2024-01-31
Target enrollment:
Participant gender:
Summary
A multi-center, prospective, open-label, controlled study of the pharmacokinetics and safety of the LicartTM topical system in pediatric and adult participants with minor soft tissue injuries. 150 male and female participants aged 6-16 and 18-45 with soft tissue injuries meeting the following criteria will be enrolled to evaluate the pharmacokinetics and safety of the Licart topical system in pediatric and adult participants with minor soft tissue injuries over a 14-day treatment course. The analgesic effects will also be evaluated of the topical system in pediatric and adult participants with minor soft tissue injuries over a 14-day treatment course. To collect principal investigator-reported global response to therapy.
Phase:
Phase 3
Details
Lead Sponsor:
IBSA Institut Biochimique SA
Treatments:
Diclofenac
Diclofenac hydroxyethylpyrrolidine