Using Nefopam Cream to Prevent Scarring in Burn Patients
A Randomized, Placebo Controlled, Double-Blind, Single Dose Study To Evaluate The Safety And Tolerability Of Cream In Burn Patients With Induced Dermal Incisions
This study is testing if Nefopam cream can help prevent scarring in burn patients by applying it to scratch wounds on their hips.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT04685577 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety, tolerability, and efficacy of Nefopam cream in preventing and treating hypertrophic scars in burn patients. The study involves creating scratch wounds on the hips of 60 adult participants with deep second or third-degree burns at two burn unit sites. Nefopam, a medication known for its pain relief properties, has shown potential anti-scarring effects in animal studies. Participants will be monitored for their response to the treatment over the course of the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with 5-70% total body surface area deep second or third-degree burns.
Not a fit: Patients with superficial burns or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of painful and disfiguring scars in burn patients, improving their quality of life.
How similar studies have performed: While the use of Nefopam for scarring is novel, previous studies have shown promise in similar approaches for scar management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Male or female burn, or trauma patients aged \>18 - \<65 years with 5-70% TBSA deep second or third degree burns who have uninjured skin in both the lateral hip regions and have voluntarily signed the Informed Consent Form (ICF).
2. Subjects with clinically acceptable results at screening for the laboratory tests specified in the trial protocol.
3. Women of childbearing potential must provide a negative pregnancy serum/urine test at time of screening and have to be compliant with an effective form of birth control throughout the entire study. Non-childbearing potential means subjects have had a history of tubal ligation or a hysterectomy or are post-menopausal with no menses for at least 1 year prior to enrolment in the study.
4. Subjects, who are, in the opinion of the Investigator, able to understand the study, co-operate with the study procedures and are willing to return to the clinic for all of the required follow-up visits.
5. Subjects must be able to cooperate with requirements of the study (e.g. able to speak, read and write English, and will be expected to be available for adverse event monitoring for the duration of the study).
6. Healthy subjects must have ALT and AST \< 2 × ULN and TB \< ULN at entry.
7. Subjects with carcinoma in situ or stage 1 cancer of the skin and other tissues will be acceptable once acceptable clinical management of the carcinoma has been established.
8. 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.
Exclusion Criteria:
1. 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.
2. Subjects who have scarring from previous interventions or evidence of thermal, electrical or radiation burn scars, tattoos, birthmarks or moles within 5 cm of the treatment site.
3. Exclusion criteria specific to burn patients in addition to the previously described factors would include severe inhalation injury requiring FiO2 \>50%, renal failure requiring dialysis or hemodynamic instability requiring vasopressor therapy at the time of initiation of therapy.
4. Subjects with a history or family history of abnormal keloid scarring.
5. Subjects with additional concurrent illnesses or conditions that may have interfered with wound healing like neoplastic, immune-mediated, or primary infectious disease (e.g. carcinoma, vasculitis, connective tissue disease, immune system disorders, rheumatoid arthritis, chronic renal impairment, significant hepatic impairment, inadequately or uncontrolled congestive heart failure or diabetes mellitus) or any clinically significant medical condition or history of any condition which may impair wound healing.
6. Subjects with a skin disorder that is chronic or currently active and which the investigator considers will adversely affect the healing of acute wounds or will involve the areas to be examined in this trial (including psoriasis, dermatitis, eczema)
7. Subjects with a body mass index \<15 or \>35 kg/m2.
8. A history of radiotherapy to the study scar area.
9. Subjects who are positive for HIV, hepatitis B or C.
10. Subjects who have known sensitivities to SCX-001 (Nefopam) Cream, structurally related compounds or any of the constituents of SCX-001 (Nefopam) Cream.
11. Subjects who have known sensitivities to EMLA cream, chlorhexidine or adhesive dressings.
12. Elder patients (\> 65 years), patients with epilepsy, patients with urinary retention, or or when administered with other anticholinergic or sympathomimetic drugs or monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants.
13. Subjects with end stage renal disease, where eGFR \</= 30 mL/min.
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Where this trial is running
Edmonton, Alberta
- University of Alberta Hospital — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Edward E Tredget, MD — University of Alberta
- Study coordinator: Nidhi Gupta, PhD
- Email: nidhi2@ualberta.ca
- Phone: 780-407-6979
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.