Licart Topical System for Soft Tissue Injuries

Recruiting in Palo Alto (17 mi)

+15 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: IBSA Institut Biochimique SA

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests a medicated patch called LicartTM on children and adults with minor injuries. The patch releases medicine through the skin to help reduce pain and swelling. The study aims to see how well it works and how safe it is.

Eligibility Criteria

This trial is for children and adults aged 6-16 and 18-45 with minor soft tissue injuries. Participants must not have used certain medications recently, be willing to use contraception if of reproductive potential, able to attend study visits, and have internet access for telehealth appointments. Pregnant or breastfeeding women, those with severe diseases or allergies to NSAIDs like diclofenac, or a history of substance abuse are excluded.

Inclusion Criteria

Willing to provide written informed consent

Male or female, 6-11 years old; 12-16 years old; or 18-45 years old

For pediatric and adult males of reproductive potential: abstinence from sexual intercourse, or use of condoms or other methods to ensure effective contraception with partner during study participation and for three (3) days following the final topical system application

+9 more

Exclusion Criteria

Prior use of over the counter (OTC) analgesics or short-acting NSAIDs (ibuprofen, ketoprofen) within 6 hours of study entry (acetaminophen permitted up until the time of study entry)

Participants with mental, behavioral, or neurodevelopmental disorders for which the relevant disorder(s) prevent compliance with the protocol

Documented nicotine dependence within 365 days of study entry

+21 more

Participant Groups

The LicartTM topical system containing diclofenac epolamine is being tested on participants with minor soft tissue injuries over a two-week period. The study aims to understand how the drug moves through the body (pharmacokinetics) and its safety profile while also assessing pain relief effectiveness.

1Treatment groups

Experimental Treatment

Group I: InvestigationalExperimental Treatment1 Intervention

LicartTM topical system application once per day for a maximum of 14 days or until pain resolution, whichever occurs first.