drugset
drugset / Trial / NCT05171673

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

NCT05171673 ↗

Phase 3 Completed 151 enrolled IBSA Institut Biochimique SA
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-10-31
Primary completion
2024-06-30
Completion
2024-07-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Diclofenac Other / unclassified 1.3 % Topical

Indications

No indication recorded.