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Licart Topical System for Soft Tissue Injuries
Study Summary
This trial will study the pharmacokinetics (how the body processes the drug) and safety of the LicartTM topical system in children and adults with minor soft tissue injuries. Analgesic effects (pain relief) will also be evaluated.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have taken strong anti-inflammatory steroid medications within the past two months.You have a history of allergic reactions, like asthma or hives, specifically triggered by aspirin or other medications like diclofenac.You have a medical condition or take medication that weakens your immune system a lot.You have had bleeding or ulcers in your digestive system in the past or currently have them.You have ongoing moderate to severe pain, rated at least 6 out of 10 on a pain scale.You have a history of alcohol or drug abuse within the past year.You have taken strong pain medications called narcotic analgesics within the past week.You currently have or have had a long-lasting pain condition in the past.You recently had a minor injury to your soft tissues within the past four days.You have an injury in your spine, fingers, hands, or the bottom of your foot.You have taken long-acting pain relievers like piroxicam or naproxen since your injury.You have a serious heart, kidney, or liver condition now or in the past.You have a severe soft tissue injury that may prevent the use of a topical treatment, unless the injury is stabilized with a device that cannot be removed.You have a skin condition or infection in the area where you are injured.You have had three or more previous injuries to the same area.You are taking medications that could interact with diclofenac and affect your safety. These medications include certain antidepressants, lithium, digoxin, blood thinners, diabetes medications, cyclosporine, methotrexate, certain antibiotics, other pain relievers, steroids, and diuretics.You have a serious illness like cancer or a severe infection.Your body mass index (BMI) is less than 32kg/m2.You have had an injury in the same area within the last three months.
- Group 1: Investigational
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the main goals of this clinical trial?
"The purpose of this 14-day clinical trial is to study the effects of a topical diclofenac solution on plasma concentrations of the drug. Secondary outcomes being monitored include safety, as assessed by vital signs like heart rate and blood pressure, and patient response to the therapy, as assessed by an investigator-reported questionnaire."
Does this study involve seniors as test subjects?
"Eligibility for this study requires that potential patients must between the ages of 6 and 45."
What does the medical research say about using Licart™ (diclofenac epolamine) topical system?
"The first clinical trial for Licart™ (diclofenac epolamine) was completed in 2009. As of now, a total of 208 have been concluded. Currently, there are 19 trials recruiting patients with many based in La Palma, California."
What is the projected number of people who will be participating in this clinical trial?
"One hundred and fifty patients are needed for this clinical trial, provided they meet the specified inclusion criteria. For example, Atella Clinical Research, LLC. in La Palma, California and Next Level Urgent Care in Houston, Texas are two of the many sites where patient participation is possible."
Has the FDA given its stamp of approval to Licart™ (diclofenac epolamine) topical system?
"Licart™ (diclofenac epolamine) topical system has been given a safety score of 3 by our team at Power. This is based on the fact that it is a Phase 3 trial, which means that there is both some efficacy data and multiple rounds of safety data supporting its use."
Are there any more positions available for participants in this research?
"That is correct. The clinicaltrials.gov website reveals that the research team is currently looking for 150 people to participate in this study at 6 different locations. The trial was first posted on October 31st, 2021 and edited January 11th, 2022."
For what medical purposes is Licart™ (diclofenac epolamine) topical system most often prescribed?
"While catarrh is the primary condition that Licart™ (diclofenac epolamine) topical system treats, it can also be used to ameliorate the symptoms of other conditions such as photorefractive keratectomy, muscle strain, and osteoarthritis of the hands."
From how many different sites is this research being directed?
"Atella Clinical Research, LLC. in La Palma, California is one of the six research sites for this study. The other participating locations are Next Level Urgent Care in Houston, Texas and University Clinical Research - Deland, LLC in DeLand, Pennsylvania among others."
Can I join this clinical trial?
"Eligible patients for this clinical trial should have sustained soft tissue injuries and be between 6-45 years old. The study is looking to enroll around 150 individuals."
Who else is applying?
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