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

NCT05171673 | Completed Phase 3 FDA Drug

• 1 other identifier: 18US-FHp04
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 11

Brief 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

Outcome Measures

Primary Outcomes (4)

• Plasma diclofenac concentration of the Licart topical system as assessed by the Diclofenac pharmacokinetic profile.

  Plasma diclofenac concentration, 24hours after initial topical system application (V2 and V5/EOS)

  14-day treatment course

• Local tolerability of the Licart topical system as assessed by a 7-point scale.

  Local tolerability assessed via a 7-point scale by the PI or designee at V2, V3, V4 and V5/EOS. The 7-point scale is: Grade 0 = Absent Response with No Visible Change. Grade 1 = Vascular Dilation Stage Response with Visible Change of Faint Redness (not considered clinically relevant). Grade 2 = Vascular Dilation Stage Response with Visible Change of Moderate Redness. Grade 3 = Vascular Dilation Stage Response with Visible Change of Intense Redness. Grade 4 = Infiltration Stage Response with Visible Change of Redness with Edema or Papules. Grade 5 = Infiltration Stage Response with Visible Change of Redness with Weeping Vesicles, Blisters or Bullae. Grade 6 = Infiltration Stage Response with Visible Change of Redness with Extension of Effect Beyond Margin of Contact Site.

  14 days treatment course

• Adverse Events as assessed by the study team

  Adverse Events for all participants as assessed by the study team during each visit throughout the duration of the study.

  14 days treatment course

• Pharmacokinetics of the Licart topical system as assessed by the activated partial thromboplastin time.

  Plasma activated partial thromboplastin time (aPTT), 24hours after initial topical system application (V2 and V5/EOS).

  14-day treatment course

Secondary Outcomes (4)

• Analgesic Effect of the Licart topical system as assessed by the Wong-Baker FACES pain score assessment scale

  14-day treatment course

• Global Response to Licart topical system as assessed by the Global Response to Therapy Investigator-reported questionnaire.

  14-day treatment course

• Safety as assessed by vital signs - blood pressure.

  14 days treatment course

• Safety as assessed by vital signs - heart rate.

  14 days treatment course

Study Arms (1)

Investigational

EXPERIMENTAL

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

Drug: Licart™ (diclofenac epolamine) topical system

Interventions

Licart™ (diclofenac epolamine) topical system DRUG

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.

Also known as: diclofenac epolamine

Investigational

Eligibility Criteria

• Age: 6 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Willing to provide written informed consent;
• Male or female, 6-11 years old; 12-16 years old; or 18-45 years old;
• BMI \<32kg/m2;
• Minor soft tissue injury within 96 hours of enrollment;
• Spontaneous pain of at least moderate intensity (i.e., pain of at least 6 on the Wong-Baker FACES® scale) according to the participant);
• Clinically significant injury according to the principal investigator;
• Willing and able to accommodate study requirements for data collection, including return for study Visits 2 and 5;
• Have access to high-speed internet, a computer, iPad, or android device for telehealth visits;
• For pediatric and adult females of reproductive potential (started the menstrual cycle): abstinence from sexual intercourse, or use of highly effective contraception for at least 30 days prior to screening, and agreement to use such a method during study participation and for three (3) days following the final topical system application;
• 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; and
• Able to read and speak English.

You may not qualify if:

• Open skin lesion or any dermatological condition (e.g., skin infection, eczema) within the injured area;
• Injury involves the spine, digits, hands, or bottom of foot;
• Prior injury to the same site within the past 90 days;
• Three or more other prior injuries (minor or major) to the region in the past;
• Injury occurred more than 96 hours prior to study entry;
• Prior use of topical medication to involved area within 48 hours of study entry;
• Hypersensitivity disorders, including asthma or urticaria, but only if associated with exposure to aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) including diclofenac;
• Coagulation defects;
• 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);
• Prior use of narcotic analgesics within seven (7) days of study entry;
• Prior use of systemic anti-inflammatory steroidal drugs within 60 days of study entry;
• Prior use of long-acting NSAIDs such as piroxicam or naproxen since injury;
• Concomitant use of drugs which may be susceptible to interactions with diclofenac, or affect safety if used concomitantly (e.g., serotonin-selective reuptake inhibitors, lithium, digoxin, anticoagulants, antidiabetic agents, cyclosporin, methotrexate, quinolone antimicrobials, other NSAIDs, steroids and diuretics);
• Participants with mental, behavioral, or neurodevelopmental disorders for which the relevant disorder(s) prevent compliance with the protocol;
• Documented alcohol or drug abuse within 365 days of study entry;

Sponsors & Collaborators

• IBSA Institut Biochimique SA: lead

Study Sites (11)

Applied Research Center

Little Rock, Arkansas, 72212, United States

Location

Atella Clinical Research, LLC.

La Palma, California, 90623, United States

Location

University Clinical Research - Deland, LLC

DeLand, Florida, 32720, United States

Location

My Community Research, Inc.

Miami, Florida, 33155, United States

Location

D & H Tamarac Research Centers, Inc.

Tamarac, Florida, 33321, United States

Location

Research Integrity

Owensboro, Kentucky, 42303, United States

Location

Ascendant Research Clinic, LLC.

Alamogordo, New Mexico, 88310, United States

Location

Prime Global Research Inc.

The Bronx, New York, 10456, United States

Location

Ascendant Research Clinic, LLC.

Marion, South Carolina, 29571, United States

Location

Next Level Urgent Care

Houston, Texas, 77057, United States

Location

AIM Trials

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Soft Tissue Injuries

Interventions

diclofenac hydroxyethylpyrrolidine; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Giuseppe Mautone, MD

  IBSA R&D Scientific Affairs

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, controlled study in pediatric and adult participants with minor soft tissue injuries. One-hundred fifty (150) participants between 6 and 11years old; 12 and 16 years old; and 18 and 45 years old will be enrolled, with equal numbers in each of the three age groups. The 50 adults enrolled will serve as the control.

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: December 29, 2021
• Study Start: October 31, 2021
• Primary Completion: June 30, 2024
• Study Completion: July 12, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)