What side effects are associated with this type of intervention?

Common treatments for soft tissue injuries often include NSAIDs like diclofenac, which are used to reduce inflammation and pain. The known side effects of topical NSAIDs such as diclofenac include local skin reactions like redness, itching, and rash. Systemic side effects, although less common with topical application, can include gastrointestinal issues (e.g., stomach pain, ulcers), cardiovascular risks (e.g., increased blood pressure, heart attack), and renal problems (e.g., kidney damage). It is important to use these medications as directed to minimize potential adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for soft tissue injuries, particularly those involving non-steroidal anti-inflammatory drugs (NSAIDs) like diclofenac. Diclofenac, available in various formulations such as gels, patches, and topical solutions, is commonly used to reduce inflammation and pain associated with soft tissue injuries. Other NSAIDs, such as ibuprofen and naproxen, are also frequently used for similar purposes, though they may not be available in topical forms. These treatments work by inhibiting the enzymes responsible for inflammation and pain, providing relief to affected areas.

What other types of research exist?

Promising novel alternatives to the LicartTM topical system for soft tissue injury patients include: 1. Topical menthol (0.5% in calamine lotion or 1% menthol) which has shown rapid symptomatic improvement in neuropathic pain and could be beneficial for soft tissue injuries. 2. Herbal anti-arthritic agents like SKI306X, which have demonstrated efficacy and safety in treating osteoarthritis and may offer anti-inflammatory benefits for soft tissue injuries. 3. Tanezumab, a monoclonal antibody targeting nerve growth factor, which has shown promise in managing pain from osteoarthritis and could be explored for soft tissue injuries.

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Nonsteroidal Anti-inflammatory Drug

Licart Topical System for Soft Tissue Injuries

Phase 3

Recruiting

Research Sponsored by IBSA Institut Biochimique SA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14-day treatment course

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include skin reactions at the application site such as redness or itching, digestive issues like nausea or indigestion due to systemic absorption of diclofenac, headaches, dizziness, and in rare cases increased risk of bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14-day treatment course

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14-day treatment course

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14-day treatment course for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events as assessed by the study team

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

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

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Secondary study objectives

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

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

Safety as assessed by vital signs - blood pressure.

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Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: InvestigationalExperimental Treatment1 Intervention

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Non-steroidal anti-inflammatory drugs (NSAIDs) like Diclofenac, used in treatments such as the LicartTM topical system, work by inhibiting cyclooxygenase (COX) enzymes, which are essential for the production of prostaglandins. Prostaglandins play a key role in promoting inflammation, pain, and fever. By reducing prostaglandin synthesis, NSAIDs effectively decrease inflammation and alleviate pain. This dual action is particularly beneficial for patients with soft tissue injuries, as it not only provides symptomatic relief but also helps to mitigate the underlying inflammatory processes, thereby promoting faster recovery and improved functionality.

Non-steroidal anti-inflammatory drugs fail to enhance healing of acute hamstring injuries treated with physiotherapy.Effects of photobiomodulation therapy and topical non-steroidal anti-inflammatory drug on skeletal muscle injury induced by contusion in rats-part 1: morphological and functional aspects.The PanAM study: a multi-center, double-blinded, randomized, non-inferiority study of paracetamol versus non-steroidal anti-inflammatory drugs in treating acute musculoskeletal trauma.