Soft Tissue InjuriesPhase 3NCT05171673
Study of PK and Safety of the LicartTM Topical System in Pediatric and Adult Participants With Minor Soft Tissue Injury
A Phase 3 study testing Licart™ (diclofenac epolamine) topical system in people with Soft Tissue Injuries, run by IBSA Institut Biochimique SA at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 45 years
- Conditions the study is for
- Soft Tissue Injuries
- What is being tested?
- Licart™ (diclofenac epolamine) topical system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 11 sitesUnited States
- Study dates
- 31 Oct 2021to 12 Jul 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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;
Show all 12Show fewer
- 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;
- Negative urine pregnancy test at inclusion for females of reproductive potential (started the menstrual cycle);
- 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.
Who cannot join
- Major soft tissue injury (fractures are only exclusionary if the injury is stabilized with a device, e.g., a hard cast, that cannot be removed to allow a topical system to be applied to the injured area);
- 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;
Show all 24Show fewer
- 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;
- Documented nicotine dependence within 365 days of study entry;
- Current or prior history of severe cardiac, renal, or hepatic impairment or disease;
- Severe systemic diseases (e.g., cancer, severe acute infection);
- Any underlying disease or medication that severely compromises the participant's immune system;
- Current or prior history of any chronic pain disorder;
- Current or prior history of gastrointestinal bleeds or, ulcers;
- Females who are pregnant or breast feeding; or
- Participation in another clinical trial within 90 days of enrollment.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Ascendant Research Clinic, LLC.
Alamogordo, New Mexico, 88310
University Clinical Research - Deland, LLC
DeLand, Florida, 32720
Next Level Urgent Care
Houston, Texas, 77057
Atella Clinical Research, LLC.
La Palma, California, 90623
Applied Research Center
Little Rock, Arkansas, 72212
Ascendant Research Clinic, LLC.
Marion, South Carolina, 29571
My Community Research, Inc.
Miami, Florida, 33155
Research Integrity
Owensboro, Kentucky, 42303
AIM Trials
Plano, Texas, 75093
D & H Tamarac Research Centers, Inc.
Tamarac, Florida, 33321
Prime Global Research Inc.
The Bronx, New York, 10456
About this study
Official title: 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
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.
Read the detailed description
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. Participants will be seen by the principal investigator (PI) or designee at the clinical site, at entry and Visits 2 and 5 following the first topical system application, with the last visit scheduled on either Day 14 or the day after the participant experiences pain resolution. Visits 3 and 4 will be conducted via telehealth. At each study visit, adverse events (AEs) and concomitant medications will be recorded, local tolerability at the application site scored on a 7-point scale, and pain assessed by participants using the Wong-Baker FACES scale. Vital signs will be measured at the screening visit and Visits 2 and 5.
Participants will also assess pain twice daily (morning and evening) at home in the Participant Diary using the same Wong-Baker FACES scale. Blood samples will be obtained from each participant at Visit 2, 24 hours (± 1 hour) after initial topical system application at Visit 1, and at the time of study discontinuation (with a topical system in place) for determination of plasma diclofenac concentration and plasma activated partial thromboplastin time (aPTT). At the End-of-Study (EOS) Visit the principal investigator will provide an assessment of global response to therapy on a 5-point scale.
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 will assess efficacy by the following assessments: Plasma diclofenac concentration, 24 hours (± 1 hour) after initial application (Visit 2) and EOS Visit; Pain score assessment by participant using the Wong-Baker FACES scale: every day (Participant Diary) and study visits on Visits 2, 3, 4 and 5; and Principal investigator assessment of global response to therapy on a 5-point scale.
This study will assess safety by the following assessments: Vital signs will be measured at the screening visit and Visit 2 and 5; AE reporting at each study visit; Local tolerability on a 7-point scale at Visits 2, 3, 4 and 5, or the day after pain resolution, with a topical system applied to the injured area; Plasma diclofenac concentration, 24 hours (±1 hour) after initial topical system application (Visit 2) and EOS Visit; and Plasma activated partial thromboplastin time (aPTT), 24 hours (±1 hour) after initial topical system application (Visit 2) and EOS Visit.
The primary endpoints of the study are: Diclofenac pharmacokinetic profile (Pediatric population vs Adult population; Two-sided 90% confidence interval (CI) <4 ng/mL); Local tolerability; AEs; and Activated partial thromboplastin time (aPTT).
The secondary endpoints of the study are: Participant-reported pain scores; Global response to therapy; and Vital signs.
All participants who receive at least one topical system will be subjected to classic safety and efficacy analyses. All participants who receive at least one topical system and have at least one blood draw to support determination of plasma diclofenac concentration will be subjected to the pharmacokinetic analysis. An evaluable participant population with adequate compliance and follow- up may also be analyzed.
Continuous variables will be presented as sample size, means, medians, standard deviations, range and 90% CI. Categorical variables will be presented as sample size, number of observations, percentages and exact 90% CI.
The participant population will be stratified by appropriate age categories and the effects of age may be analyzed using Analysis of Variance (ANOVA) or multiple regression methods.
Plasma diclofenac concentration in pediatric participants will be compared with those of adults using repeated measures mixed models (participants will have reached steady-state blood concentration by the time of the first blood draw).
- Conditions
- Soft Tissue Injuries
- Being tested
- Licart™ (diclofenac epolamine) topical system
- Medical subject headings
- Soft Tissue Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Licart™ (diclofenac epolamine) topical systemDrug
Also called diclofenac epolamine
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.
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Experimental | LicartTM topical system application once per day for a maximum of 14 days or until pain resolution, whichever occurs first. Receives: Drug: Licart™ (diclofenac epolamine) topical system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Diclofenac Concentration of Licart™ Topical System at V2 and V5/EOS.
The blood was withdrawn at Visit 2, 24 hours (± 1 hour) after initial topical system application on Visit 1, and the day following pain resolution or at the end of study (EOS - Day 14). Age-group based comparisons were performed using ANOVA.
Measured: 24 hours post-application (day 2 - V2), and Day 14 (V5) or one day after pain resolution (EOS)
Local Tolerability of the Licart™ Topical System as Assessed by a 7-point Scale.
Local tolerability of the Licart™ topical system was assessed by the PI, on a 7-point scale, ranging from 0 to 6 (6 = Redness with extension of effect beyond margin of contact site; 5 = Redness with weeping vesicles, blisters, or bullae; 4 = Redness with edema or papules; 3 = Intense redness; 2= Moderate redness, 1= Faint redness [not considered clinically relevant], 0 = none). The data of the participants with local tolerability score '0' are presented. Percentages are based on the total number of participants available at each study visit. Age-group based comparisons were performed using the Cochran-Mantel-Haenszel (CMH) test. CMH test p-value was not available for comparisons with less than two non-missing levels. Therefore, p-values were not available (NA) for V4 and V5/EOS for any of the group and also NA for age groups 6-11 vs 12-16 at V2 and age group 6-11 vs adult group at V3.
Measured: 24 hours post-application (day 2 - V2), Day 4 (V3), Day 7 (V4), and Day 14 (V5) or EOS (the day after pain resolution)
Number of Participants With Adverse Events as Assessed by the Study Team
Adverse events data were collected from the time the informed consent was obtained until the end of the study. It included exacerbation of a pre-existing medical condition, which increased in severity, frequency and/or duration (Information is available in Adverse Events section)
Measured: 14 days after participant received first dose
Pharmacokinetics of the Licart™ Topical System as Assessed by the Activated Partial Thromboplastin Time (aPTT)
Plasma aPTT at V2, assessed 24 hours (± 1 hour) after initial topical system application at V1 and at V5/EOS. aPTT was analyzed as raw aPTT value for adult groups while for both pediatric subgroups it was derived by subtracting 7.9 seconds from the raw values, i.e. the maximum difference between the normal values ranges for the two pediatric subgroups (6-11 years; 12-16 years) and the normal values range of adult participants, based on available relevant scientific literature. For each individual time point aPTT values were presented and summarized as means, SDs, and 90% CI of the means. Age-group based comparisons were performed using ANOVA (see Outcome Measure 5 for MMRM Model).
Measured: 24 hours post-application (day 2 - V2), and Day 14 (V5) or one day after pain resolution (EOS)
Secondary outcomes (4)
Study-visit Participants -Reported Pain Scores Assessed by the Wong-Baker FACES Pain Rating Scale
Pain was assessed by the participant using the Wong-Baker FACES scale during each study visit at V1, V2, V3, V4, V5/EOS. The pain score options are as follows: 0 = No Hurt, 2 = Hurts Little Bit, 4 =Hurts Little More, 6 = Hurts Even More, 8 =Hurts Whole Lot, 10 = Hurts Worst. The lower the score, the better the outcome; the higher the score, the worse the outcome. Age-group based comparisons were performed using ANOVA.
Measured: Day 1 (V1), 24 hours post-application (day 2 - V2), Day 4 (V3), Day 7 (V4), and Day 14 (V5) or one day after pain resolution (EOS)
Global Response to Licart™ Topical System as Assessed by the Global Response to Therapy Investigator-reported Questionnaire
Global response to therapy was assessed by the PI or designee on a 5-point scale (1= No clinical improvement in pain intensity and/or functional performance, 2= Slight clinical improvement in pain intensity and/or functional performance, 3= Moderate clinical improvement in pain intensity and/or functional performance, 4= Marked clinical improvement in pain intensity and/or functional performance, 5= Restoration of normal functional performance in the absence of any pain). Age-group based comparisons were performed using the Cochran- Mantel-Haenszel (CMH) test. 90% CI was used as measure of dispersion.
Measured: on Day 14 (V5) or one day after pain resolution (EOS)
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Vital sign included SBP and DBP. Vital Sign summarized as change from Baseline by visit at Visit 2 and V5/EOS. Values at screening were considered as Baseline value. Change from Baseline was calculated as visit value - value at screening.
Measured: 24 hours post-application (Day 2 - V2), and Day 14 (V5) or one day after pain resolution (EOS)
Change From Baseline in Heart Rate (HR)
Vital sign included HR. Vital Sign summarized as change from Baseline by visit at Visit 2 and V5/EOS. Values at screening were considered as Baseline value. Change from Baseline was calculated as visit value - value at screening.
Measured: 24 hours post-application (day 2 - V2), and Day 14 (V5) or one day after pain resolution (EOS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start31 Oct 2021
- Primary completion30 Jun 2024
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Soft Tissue InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBSA Institut Biochimique SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giuseppe Mautone, MD, Study director, IBSA R&D Scientific Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171673
- Sponsor's protocol ID
- 18US-FHp04
- Status last verified
- Sep 2026
- First submitted
- 9 Nov 2021
- Last updated
- 30 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05171673
- Acronym / sponsor ID
- 18US-FHp04
- Conditions
- Soft Tissue Injuries
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- IBSA Institut Biochimique SAIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 29 Dec 2021 (actual)
- Results
- Posted 30 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Participants will be seen by the principal investigator (PI) or designee at the clinical site, at entry and Visits 2 and 5 following the first topical system application, with the last visit scheduled on either Day 14 or the day after the participant experiences pain resolution. Visits 3 and 4 will be conducted via telehealth. At each study visit, adverse events (AEs) and concomitant medications will be recorded, local tolerability at the application site scored on a 7-point scale, and pain assessed by participants using the Wong-Baker FACES scale. Vital signs will be measured at the screening visit and Visits 2 and 5.
Participants will also assess pain twice daily (morning and evening) at home in the Participant Diary using the same Wong-Baker FACES scale. Blood samples will be obtained from each participant at Visit 2, 24 hours (± 1 hour) after initial topical system application at Visit 1, and at the time of study discontinuation (with a topical system in place) for determination of plasma diclofenac concentration and plasma activated partial thromboplastin time (aPTT). At the End-of-Study (EOS) Visit the principal investigator will provide an assessment of global response to therapy on a 5-point scale.
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 will assess efficacy by the following assessments: Plasma diclofenac concentration, 24 hours (± 1 hour) after initial application (Visit 2) and EOS Visit; Pain score assessment by participant using the Wong-Baker FACES scale: every day (Participant Diary) and study visits on Visits 2, 3, 4 and 5; and Principal investigator assessment of global response to therapy on a 5-point scale.
This study will assess safety by the following assessments: Vital signs will be measured at the screening visit and Visit 2 and 5; AE reporting at each study visit; Local tolerability on a 7-point scale at Visits 2, 3, 4 and 5, or the day after pain resolution, with a topical system applied to the injured area; Plasma diclofenac concentration, 24 hours (±1 hour) after initial topical system application (Visit 2) and EOS Visit; and Plasma activated partial thromboplastin time (aPTT), 24 hours (±1 hour) after initial topical system application (Visit 2) and EOS Visit.
The primary endpoints of the study are: Diclofenac pharmacokinetic profile (Pediatric population vs Adult population; Two-sided 90% confidence interval (CI) <4 ng/mL); Local tolerability; AEs; and Activated partial thromboplastin time (aPTT).
The secondary endpoints of the study are: Participant-reported pain scores; Global response to therapy; and Vital signs.
All participants who receive at least one topical system will be subjected to classic safety and efficacy analyses. All participants who receive at least one topical system and have at least one blood draw to support determination of plasma diclofenac concentration will be subjected to the pharmacokinetic analysis. An evaluable participant population with adequate compliance and follow- up may also be analyzed.
Continuous variables will be presented as sample size, means, medians, standard deviations, range and 90% CI. Categorical variables will be presented as sample size, number of observations, percentages and exact 90% CI.
The participant population will be stratified by appropriate age categories and the effects of age may be analyzed using Analysis of Variance (ANOVA) or multiple regression methods.
Plasma diclofenac concentration in pediatric participants will be compared with those of adults using repeated measures mixed models (participants will have reached steady-state blood concentration by the time of the first blood draw).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Investigational | Experimental | Drug: Licart™ (diclofenac epolamine) topical systemLicartTM topical system application once per day for a maximum of 14 days or until pain resolution, whichever occurs first. |
Who may qualify
- Ages
- 6 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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);
Key exclusion criteria (24 listed)
- Major soft tissue injury (fractures are only exclusionary if the injury is stabilized with a device, e.g., a hard cast, that cannot be removed to allow a topical system to be applied to the injured area);
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Licart™ (diclofenac epolamine) topical systemAlso: diclofenac epolamineThe 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. | Drug | Investigational |
Primary outcome
Plasma Diclofenac Concentration of Licart™ Topical System at V2 and V5/EOS.
Time frame: 24 hours post-application (day 2 - V2), and Day 14 (V5) or one day after pain resolution (EOS)
The blood was withdrawn at Visit 2, 24 hours (± 1 hour) after initial topical system application on Visit 1, and the day following pain resolution or at the end of study (EOS - Day 14). Age-group based comparisons were performed using ANOVA.
Local Tolerability of the Licart™ Topical System as Assessed by a 7-point Scale.
Time frame: 24 hours post-application (day 2 - V2), Day 4 (V3), Day 7 (V4), and Day 14 (V5) or EOS (the day after pain resolution)
Local tolerability of the Licart™ topical system was assessed by the PI, on a 7-point scale, ranging from 0 to 6 (6 = Redness with extension of effect beyond margin of contact site; 5 = Redness with weeping vesicles, blisters, or bullae; 4 = Redness with edema or papules; 3 = Intense redness; 2= Moderate redness, 1= Faint redness [not considered clinically relevant], 0 = none). The data of the participants with local tolerability score '0' are presented. Percentages are based on the total number of participants available at each study visit. Age-group based comparisons were performed using the Cochran-Mantel-Haenszel (CMH) test. CMH test p-value was not available for comparisons with less than two non-missing levels. Therefore, p-values were not available (NA) for V4 and V5/EOS for any of the group and also NA for age groups 6-11 vs 12-16 at V2 and age group 6-11 vs adult group at V3.
Number of Participants With Adverse Events as Assessed by the Study Team
Time frame: 14 days after participant received first dose
Adverse events data were collected from the time the informed consent was obtained until the end of the study. It included exacerbation of a pre-existing medical condition, which increased in severity, frequency and/or duration (Information is available in Adverse Events section)
Pharmacokinetics of the Licart™ Topical System as Assessed by the Activated Partial Thromboplastin Time (aPTT)
Time frame: 24 hours post-application (day 2 - V2), and Day 14 (V5) or one day after pain resolution (EOS)
Plasma aPTT at V2, assessed 24 hours (± 1 hour) after initial topical system application at V1 and at V5/EOS. aPTT was analyzed as raw aPTT value for adult groups while for both pediatric subgroups it was derived by subtracting 7.9 seconds from the raw values, i.e. the maximum difference between the normal values ranges for the two pediatric subgroups (6-11 years; 12-16 years) and the normal values range of adult participants, based on available relevant scientific literature. For each individual time point aPTT values were presented and summarized as means, SDs, and 90% CI of the means. Age-group based comparisons were performed using ANOVA (see Outcome Measure 5 for MMRM Model).
4 secondary outcomes
Study-visit Participants -Reported Pain Scores Assessed by the Wong-Baker FACES Pain Rating Scale
Time frame: Day 1 (V1), 24 hours post-application (day 2 - V2), Day 4 (V3), Day 7 (V4), and Day 14 (V5) or one day after pain resolution (EOS)
Global Response to Licart™ Topical System as Assessed by the Global Response to Therapy Investigator-reported Questionnaire
Time frame: on Day 14 (V5) or one day after pain resolution (EOS)
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Time frame: 24 hours post-application (Day 2 - V2), and Day 14 (V5) or one day after pain resolution (EOS)
Change From Baseline in Heart Rate (HR)
Time frame: 24 hours post-application (day 2 - V2), and Day 14 (V5) or one day after pain resolution (EOS)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Soft Tissue Injuries
Recruiting
Monitored Anesthesia Care and Soft Tissue Infiltration With Local Anesthesia Feasibility Trial
Hip Fracture Surgeries, Intertrochanteric Fracture
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2/3
Lactoferrin Nanohydrogel for Soft And Hard Tissue Healing and Implant Stability in Immediate Implant Placement
Dental Implant, Wound Healing
Recruiting
Irrigating vs Traditional Negative Pressure Wound Therapy to Treat Necrotizing Soft Tissue Infections
Necrotizing Soft Tissue Infections
Recruiting
The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix®
Necrotizing Fascitis, Necrotizing Soft Tissue Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Mautone, MD study director
IBSA R&D Scientific Affairs
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Licart™ (diclofenac epolamine) topical system in people with Soft Tissue Injuries, run by IBSA Institut Biochimique SA at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Diclofenac Concentration of Licart™ Topical System at V2 and V5/EOS. (time frame: 24 hours post-application (day 2 - V2), and Day 14 (V5) or one day after pain resolution (EOS)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.