Nefopam Cream for Burns

Overseen By Nidhi Gupta, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Alberta

Must not be taking: Anticholinergics, MAOIs, Tricyclics, others

Disqualifiers: Epilepsy, Diabetes, Renal disease, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 27

Duration: 3 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a cream called Nefopam to determine if it can prevent or reduce severe scars after burns or other skin injuries. Scars from burns can be painful, itchy, and limit movement, so an effective treatment could aid physical and psychological recovery. The study will compare Nefopam cream to a placebo (a cream without the active drug) on small scratches made on the hips of burn patients. It is open to burn patients with uninjured skin on their hips who can complete follow-up visits. The goal is to develop a useful cream for reducing scarring, potentially benefiting both military and civilian patients.

As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking certain medications like anticholinergic drugs, sympathomimetic drugs, monoamine oxidase inhibitors (MAOIs), or tricyclic antidepressants, you may need to consult with the trial team as these are mentioned in the exclusion criteria.

Is there any evidence suggesting that Nefopam Cream is likely to be safe for humans?

Research has shown that Nefopam has been safely used in people for over 30 years. It is usually well-tolerated, with mild side effects such as nausea, sweating, dry mouth, and a faster heartbeat. These side effects are not serious and typically resolve on their own.

Additionally, tests on healthy individuals have confirmed Nefopam's safety, increasing confidence that the cream version might also be safe for treating scars in burn patients. Since this study is in the second phase, the main goal is to assess both the safety of the cream and its effectiveness on scars. This indicates that the treatment has shown promise in earlier tests. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for burns?

Unlike standard burn treatments that often rely on pain relief via oral medications or topical antibiotics, Nefopam Cream represents a novel approach by using a topical application of Nefopam, an active ingredient known primarily for its pain-relieving properties. Researchers are excited because this cream is applied directly to the healing skin, potentially providing targeted relief during the critical proliferative phase of wound healing without systemic side effects. Additionally, the topical delivery method of Nefopam Cream could offer a more convenient and potentially faster-acting option for burn patients, enhancing comfort and recovery.

What evidence suggests that Nefopam Cream might be an effective treatment for burn scars?

Research has shown that Nefopam cream, which participants in this trial may receive, can help reduce scarring in human wounds. Commonly used for pain relief in Europe, this cream has also reduced scarring in animal studies with rats and pigs. In humans, it has proven safe and effective for minimizing scars in controlled skin injuries. Applied to healing skin, the cream has been tested for its ability to lessen the thickness and redness of scars. These findings suggest that Nefopam cream could help prevent and treat severe scars after burns. ^{1 2 5 6 7}

Who Is on the Research Team?

Edward E Tredget, MD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

Adult burn or trauma patients aged 18-65 with certain types of burns, who can understand and follow study procedures. They must have healthy liver function, no history of abnormal scarring, and not be involved in other healing trials. Women should use birth control and not be pregnant. People with well-managed HIV may join after expert consultation.

Inclusion Criteria

Patients who have well controlled HIV as defined by a viral load amount of HIV in the blood that is undetectable i.e. a: viral load less than 40 to 50 copies/ml and cannot be detected by standard tests for HIV, Hep B or Hep C will be included after consultation with an infectious disease expert

I understand the study, can follow its procedures, and will attend all required visits.

Healthy subjects must have ALT and AST < 2 × ULN and TB < ULN at entry

Exclusion Criteria

Currently Subjects involved any other intervention trial(s) where the intervention could possibly affect wound healing to be eligible for enrolment in the SCX-001 (Nefopam) Cream study

I do not have severe lung damage, kidney failure needing dialysis, or unstable blood pressure needing strong medicine.

Subjects who are positive for HIV, hepatitis B or C

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive NEFOPAM Cream or placebo applied to healing deep dermal scratches for 21 days

3 weeks

Daily visits for wound evaluation and treatment application

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including digital photography, Mexameter, and ultrasound evaluations

12 weeks

Visits at Day 27, Day 48, Day 76, and Day 104

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Nefopam Cream
• Placebo (Vehicle)

Trial Overview The trial is testing Nefopam Cream's ability to prevent or reduce scarring in burn patients by comparing it to a placebo cream. Patients will receive both treatments on different sides of the hip and undergo regular assessments including photographs, ultrasound for scar thickness, color measurements, and personal scar evaluations.

How Is the Trial Designed?

Group I: Nefopam Experimental Treatment 1 Intervention

NEFOPAM 3% cream will be applied topically to healing deep dermal scratches in the lateral hip of burn patients daily (twice) for 3 weeks during the proliferative phase of wound healing.

Group II: Placebo Placebo Group 1 Intervention

This will work as a placebo for the experimental drug.

Nefopam Cream is already approved in European Union for the following indications:

Approved in European Union as Acupan for:

• Moderate to severe pain
• Post-surgical pain
• Prevention of shivering during surgery or recovery from surgery

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

Nefopam (NFP) is a non-opioid analgesic that works through mechanisms similar to triple neurotransmitter reuptake inhibitors, making it particularly effective for treating neuropathic pain.

To minimize side effects like nausea and dizziness, NFP should be administered intravenously in doses of 20 mg over 15-20 minutes or as a continuous infusion of 60-120 mg per day.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rediscovery of nefopam for the treatment of neuropathic pain. Kim, KH., Abdi, S.[2022]

A study involving 12 healthy male subjects found that both the reference and test formulations of nefopam tablets had similar pharmacokinetic profiles, indicating comparable bioavailability after a single 30 mg dose.

The maximum plasma concentration (C(max)) and the time to reach maximum concentration (T(max)) were nearly identical for both formulations, suggesting that they can be considered equivalent in terms of how the body absorbs and processes the drug.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of pharmacokinetics and comparative bioavailability of nefopam 30 mg tablets in twelve fasting healthy Pakistani male young subjects: single-dose, randomized, two-period, two-treatment and two-way cross-over design. Ahmad, M., Yaqoob, M., Murtaza, G.[2013]

A systematic review found no clinical studies demonstrating the efficacy of oral nefopam for treating acute postoperative pain, indicating that its use for this purpose is not justified.

Due to the lack of evidence supporting nefopam's analgesic properties in postoperative settings, further evaluation of its use in other pain conditions is necessary, especially given the availability of other effective pain relief options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single dose oral nefopam for acute postoperative pain in adults. Kakkar, M., Derry, S., Moore, RA., et al.[2022]

In a study involving 90 patients, nefopam was found to provide comparable pain relief to pentazocine for postoperative pain, but with a longer duration of action.

Nefopam had a lower impact on respiratory function compared to pentazocine, making it a safer option for patients, although it was associated with increased drowsiness and sweating.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nefopam in postoperative pain. Calmi, D., Pagnoni, B., Tiengo, M., et al.[2013]

In a study of 90 patients undergoing laparoscopic cholecystectomy, nefopam combined with fentanyl significantly reduced pain levels compared to fentanyl alone, particularly at 10 minutes, 2 hours, and 6 hours post-surgery.

The combination of fentanyl with 20 mg of nefopam not only provided effective pain relief but also resulted in lower nausea and shivering compared to higher doses of nefopam and fentanyl alone, indicating a safer profile for postoperative analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The analgesic effect of nefopam with fentanyl at the end of laparoscopic cholecystectomy. Lee, JH., Kim, JH., Cheong, YK.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04685577

Safety, Tolerability and Efficacy of Nefopam Cream in Burn ... Drug Information: NEFOPAM HCL has been found safe and effective for the reduction of dermal scarring following standardized human dermal wounds of critical ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04685577/safety-tolerability-and-efficacy-of-nefopam-cream-in-burn-patients

Safety, Tolerability and Efficacy of Nefopam Cream in Burn ... Drug Information: NEFOPAM HCL has been found safe and effective for the reduction of dermal scarring following standardized human dermal wounds ...

3. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT04685577/

Trial | NCT04685577 Nefopam HCl has been found safe and effective for the reduction of dermal scarring following standardized human dermal wounds of critical depth that produces ...

4. withpower.com withpower.com/trial/phase-3-burns-5-2021-1181d

Nefopam Cream for Burns ... Nefopam has shown promise in reducing scar tissue. The cream will be applied to small wounds on the patients' hips, and its effectiveness will be evaluated.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11954109/

A meta analysis of efficacy and safety of nefopam for ... The analysis revealed that compared to placebo, nefopam had no statistically significant effect on the reduction of postoperative pain severity ...

6. biosynth.com biosynth.com/Files/MSDS/FN/26/MSDS_FN26174_4000_EN.pdf

Safety Data Sheet Avoid ingestion and inhalation. Avoid prolonged or repeated exposure. Remove contaminated clothing and wash before reuse. Wash thoroughly after ...

7. cdn.caymanchem.com cdn.caymanchem.com/cdn/msds/38137m.pdf

Safety Data Sheet Supply fresh air or oxygen; call for doctor. In case of unconsciousness place patient stably in side position for transportation. · After skin ...