Licart Topical System for Soft Tissue Injuries

No longer recruiting at 16 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a topical treatment called Licart™ to evaluate its safety and effectiveness in relieving pain from minor soft tissue injuries, such as sprains or strains. Researchers aim to understand how the body absorbs the treatment and its pain-relief efficacy over a 14-day period. Participants apply the treatment once daily until the pain subsides or for up to 14 days. Suitable candidates for this trial are those who have experienced a minor soft tissue injury within the last 96 hours and have moderate pain. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the availability of a new pain relief option.

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 there any evidence suggesting that the Licart™ topical system is likely to be safe for humans?

Research shows that the Licart™ patch, containing diclofenac epolamine, is generally safe. Diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), helps relieve pain. Studies have found that similar diclofenac patches are safe for treating sudden pain from minor muscle and tissue injuries, with no major side effects reported.

The FDA has approved Licart for treating sudden pain from minor strains, sprains, and bruises, indicating its safety for use. Typically, one patch is applied to the most painful area once a day. This method provides focused pain relief with few side effects. Overall, evidence supports Licart as a safe choice for managing minor muscle and tissue injuries. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Licart™ is unique because it delivers pain relief through a topical system, which is different from the standard oral or injectable treatments for soft tissue injuries. This method allows the active ingredient, diclofenac epolamine, to target pain directly at the site of injury, potentially reducing systemic side effects commonly associated with oral NSAIDs. Researchers are excited about Licart™ because it offers the convenience of once-daily application and has the potential to resolve pain within a much shorter timeframe, possibly just 14 days or even less.

What evidence suggests that the Licart topical system might be an effective treatment for soft tissue injuries?

Research shows that Licart, a skin treatment with diclofenac, reduces pain from minor injuries like strains and sprains. Studies have found that diclofenac, the active ingredient in Licart, significantly lowers pain and is generally well tolerated by users. In a review of different studies, 74% of patients using diclofenac on their skin reported successful pain relief. Another study found that similar diclofenac patches are safe and effective for treating sudden pain from soft tissue injuries. This evidence supports Licart's potential to manage pain in people with minor soft tissue injuries. Participants in this trial will apply the Licart topical system once per day for a maximum of 14 days or until pain resolves, whichever occurs first. ^{1 2 4 6 7}

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. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/206976s016lbl.pdf

Reference ID: 5482843 - accessdata.fda.gov LICART is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions. 2 DOSAGE AND ADMINISTRATION. 2.1 Important Dosage and ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK78588/

Review of the efficacy and tolerability of the diclofenac ... - NCBI The review concluded that diclofenac epolamine topical patch 1.3% significantly reduced pain in patients with soft tissue injuries and was well tolerated.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05171673

Study of PK and Safety of the LicartTM Topical System in ... Participants will be asked to apply the Licart topical system once per day for a maximum of 14 days or until pain resolution, whichever occurs first. This study ...

4. withpower.com withpower.com/trial/phase-3-soft-tissue-injuries-9-2021-3e59a

Licart Topical System for Soft Tissue Injuries 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 ...

5. medicaid.nv.gov medicaid.nv.gov/Downloads/provider/Topical_NSAIDs_2019-06.pdf

Therapeutic Class Overview Based on 10 studies, 74% of patients treated with topical diclofenac experienced a successful treatment outcome, compared to 47% with placebo ( ...

6. licart.com licart.com/licart-use-important-safety-information/

Licart Use & Important Safety Information LICART contains diclofenac epolamine, which is a nonsteroidal anti-inflammatory drug (NSAID), and is indicated for the topical treatment of acute pain.

7. biospace.com biospace.com/licart-now-available-to-treat-acute-pain-due-to-minor-strains-sprains-and-contusions

Licart™ Now Available to Treat Acute Pain Due to Minor ... Licart is the first and only once-a-day topical nonsteroidal anti-inflammatory drug (NSAID) therapy approved by the FDA.