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

NCT05171673 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2024-12-10

No results posted yet for this study

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.

Conditions

  • Soft Tissue Injuries

Interventions

DRUG

Licart™ (diclofenac epolamine) topical system

The Licart™ (diclofenac epolamine) topical system was designed to deliver the nonsteroidal anti-inflammatory drug (NSAID) diclofenac to the site of a minor soft tissue injury through topical application. This investigational product (IP) is a 10 cm x 14 cm topical system comprised of an adhesive material containing 1.3% diclofenac epolamine that is bound to a non-woven polyester felt backing and covered with a polypropylene film release liner. The release liner is removed prior to topical application to the skin.

Sponsors & Collaborators

  • IBSA Institut Biochimique SA

    lead INDUSTRY

Principal Investigators

  • Giuseppe Mautone, MD · IBSA R&D Scientific Affairs

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2024-06-30
Completion
2024-07-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05171673 on ClinicalTrials.gov