CompletedPhase 2

Safety, Tolerability and Efficacy of Nefopam Cream in Burn Patients

Canada50 participantsStarted 2022-07-10

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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).
✓. Subjects with clinically acceptable results at screening for the laboratory tests specified in the trial protocol.
✓. 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.
✓. 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.
✓. 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).
✓. Healthy subjects must have ALT and AST \< 2 × ULN and TB \< ULN at entry.
✓. 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.

What they're measuring

Assessment of efficacy by measuring scar/wound area at day 1.

Timeframe: Digital photography of the wound/scar will be performed at day 1.

Assessment of efficacy by measuring scar/wound area at day 21.

Timeframe: Digital photography of the wound/scar will be performed at day 21.

Assessment of efficacy by measuring scar/wound area at day 27.

Timeframe: Digital photography of the wound/scar will be performed at day 27.

Assessment of efficacy by measuring scar/wound area at day 48.

Timeframe: Digital photography of the wound/scar will be performed at day 48.

Assessment of efficacy by measuring scar/wound area at day 76.

Timeframe: Digital photography of the wound/scar will be performed at day 76.

Assessment of efficacy by measuring scar/wound area at day 104.

Timeframe: Digital photography of the wound/scar will be performed at day 104.

Assessment of efficacy by measuring scar/wound depth at day 1.

Timeframe: Dermal ultrasound analysis of the wound/scar will be performed at day 1.

Trial details

NCT IDNCT04685577

SponsorUniversity of Alberta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-31

View on ClinicalTrials.gov More Burn; Multiple Body Regions, Max. Second Degree trials