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

PHASE3CompletedINTERVENTIONAL
Enrollment

151

Participants

Timeline

Start Date

October 31, 2021

Primary Completion Date

June 30, 2024

Study Completion Date

July 12, 2024

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.

Trial Locations (11)

10456

Prime Global Research Inc., The Bronx

29571

Ascendant Research Clinic, LLC., Marion

32720

University Clinical Research - Deland, LLC, DeLand

33155

My Community Research, Inc., Miami

33321

D & H Tamarac Research Centers, Inc., Tamarac

42303

Research Integrity, Owensboro

72212

Applied Research Center, Little Rock

75093

AIM Trials, Plano

77057

Next Level Urgent Care, Houston

88310

Ascendant Research Clinic, LLC., Alamogordo

90623

Atella Clinical Research, LLC., La Palma

Sponsors
All Listed Sponsors
lead

IBSA Institut Biochimique SA

INDUSTRY

NCT05171673 - Study of PK and Safety of the LicartTM Topical System in Pediatric and Adult Participants with Minor Soft Tissue Injury | Biotech Hunter | Biotech Hunter