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RECRUITING

NCT04685577

PHASE2

Safety, Tolerability and Efficacy of Nefopam Cream in Burn Patients

Sponsor: University of Alberta

View on ClinicalTrials.gov

Summary

Burn patients very commonly develop abnormal scars after injury which can be red, raised or elevated, painful and very itchy. They can prevent normal movement of hands and other joints and lead to ugly deformities which makes physical and psychological recovery very difficult. This proposal seeks to test the usefulness of a cream called Nefopam to prevent and treat these bad scars after burns and other injury to the skin. Nefopam is a drug that has been used as a pain medicine in Europe but has been found to have anti-scarring properties in rats and pigs. It has been tested in healthy people and found to be well tolerated and safe. The study purposes to make a scratch in the hip skin in 60 adult burn patients at two burn unit sites, the University of Alberta and the University of California at Davis, Sacramento CA. Burn patients in the study will have a scratch wound in the skin of the each side of the hip, part way through the thickness of the skin which is shallow at first but gets deeper. This scratch is made with a special guide which precisely controls the length and depth of the scratch so that each scratch is the same. Part of the scratch heals without scar and the deeper part heals with a red raised scar over a small region less than 2 inches long. One side will be treated with the drug and the other with a control or placebo are in a white cream that is indistinguishable, where you cannot tell which side contains the drug. Once the wound is nearly healed, usually less than 21 days, the cream will be applied twice daily for three weeks. Measurements will be done about once per month for four months where the healing scratches will be photographed, measurements of the thickness made with ultrasound and mexameter for scar color or pigment and redness. Ultrasound is a painless probe that uses sound waves to measure scar thickness and mexameter is a painless probe on the surface of the scratch to measure color and redness. Both measurements take only minutes to complete. Patients will be asked to answer a scar assessment form about on how they feel each scratch during the treatment and the research staff will also the complete scar form as well. It is the aim of the study to find a cream the works to prevent and reduce scarring after burn injury in military or civilian patients. In the future, an useful cream for scarring in burn patients may also be helpful for other skin damage which leads to scarring.

Official title: A Randomized, Placebo Controlled, Double-Blind, Single Dose Study To Evaluate The Safety And Tolerability Of Cream In Burn Patients With Induced Dermal Incisions

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-07-10

Completion Date

2026-12

Last Updated

2025-01-22

Healthy Volunteers

Conditions

Burn; Multiple Body Regions, Max. Second Degree Third-Degree Burn Burn Degree Second

Interventions

DRUG

Nefopam

Nefopam HCl inhibits the proliferation and viability of human mesenchymal fibroblasts with elevated β-catenin expression without affecting normal fibroblasts. Nefopam HCl primarily targets cells in which β-catenin is above normal physiologic levels. This threshold effect makes Nefopam HCl a good prospective therapeutic agent by limiting its effect to abnormal mesenchymal cells.Nefopam HCl has been found safe and effective for the reduction of dermal scarring following standardized human dermal wounds of critical depth that produces HTS in normal human volunteers Phase 1 study. In the current study, it is proposed that the concentration of the cream will be 3% and the timing of application will be delayed until after re-epithelialization at about 21 days to maximize the antiproliferative effects of NEFOPAM during the fibrotic/proliferative phase of healing.

OTHER

Placebo (Vehicle)

Participants will receive vehicle with out the investigational product

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. \-

Locations (1)

University of Alberta Hospital

Edmonton, Alberta, Canada