Licart Topical System for Soft Tissue Injuries

Recruiting at 15 trial locations

Overseen By Serena Caverzasio

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: IBSA Institut Biochimique SA

Must not be taking: Narcotics, Long-acting NSAIDs, Steroids, others

Disqualifiers: Major injury, Skin conditions, Asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 2 weeks

151 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial requires stopping certain medications before joining. You must not have used over-the-counter pain relievers like ibuprofen within 6 hours, narcotic painkillers within 7 days, or certain anti-inflammatory drugs within 60 days of starting the study. Check with the trial team about your specific medications.

Is the Licart Topical System generally safe for use in humans?

A study on a diclofenac patch, similar to the Licart Topical System, found it to be safe for treating acute pain from soft tissue injuries, with no significant skin irritation observed in trials. ^{1 2 3 4 5}

How is Licart™ different from other treatments for soft tissue injuries?

Licart™ is a topical system, meaning it is applied directly to the skin, which can provide targeted relief to the injured area without the need for oral medication. This method can reduce the risk of systemic side effects (effects that impact the whole body) that are often associated with oral treatments. ^{6 7 8 9 10}

Who Is on the Research Team?

Giuseppe Mautone, MD

Principal Investigator

IBSA R&D Scientific Affairs

Are You a Good Fit for This Trial?

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

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

Willing and able to accommodate study requirements for data collection, including return for study Visits 2 and 5

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants apply the Licart topical system once per day for a maximum of 14 days or until pain resolution

2 weeks

5 visits (2 in-person, 3 virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Licart™

Trial Overview 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.

How Is the Trial Designed?

Group I: Investigational Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

IBSA Institut Biochimique SA

Lead Sponsor

Trials

42

Recruited

10,300+

Citations

1. England pubmed.ncbi.nlm.nih.gov

A randomised placebo-controlled safety and acceptability trial of PRO 2000 vaginal microbicide gel in sexually active women in Uganda. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Assessment of diclofenac permeation with different formulations: anti-inflammatory study of a selected formula. [2019]

3. Canada pubmed.ncbi.nlm.nih.gov

Excipients in topical corticosteroid preparations in Canada. [2018]

4. Italy pubmed.ncbi.nlm.nih.gov

Diclofenac patch for the treatment of acute pain caused by soft tissue injuries of limbs: a randomized, placebo-controlled clinical trial. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Astringent drug products that produce aluminum acetate; skin protectant drug products for over-the-counter human use; technical amendment. Final rule; technical amendment. [2009]

6. China pubmed.ncbi.nlm.nih.gov

[Experimental study on closing the firearm injured soft tissue defect by skin stretch]. [2012]

7. China pubmed.ncbi.nlm.nih.gov

[Systemic therapy for defects of skin and soft tissue on the knees after severe trauma or burn]. [2013]

8. China pubmed.ncbi.nlm.nih.gov

[Application of modified adjustable skin stretching and secure wound-closure system in repairing of skin and soft tissue defect]. [2022]

9. China pubmed.ncbi.nlm.nih.gov

[Repair of circumferential wound in the wrist region due to high-voltage electrical burn using combined abdominal axial pattern flaps]. [2022]

10. Poland pubmed.ncbi.nlm.nih.gov

THE MANAGEMENT OF THE VICTIMS WITH GUNSHOT WOUNDS OF THE EXTREMITIES WITH EXTENSIVE DEFECTS OF THE SOFT TISSUES AT THE LEVEL OF QUALIFIED MEDICAL CARE. CASE-SERIES. [2023]