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Nefopam Cream for Burns
Study Summary
This trial is testing the effectiveness of a cream called Nefopam in preventing and treating abnormal scars after burns. Nefopam is a drug that has been found to have anti-scarring properties in rats and pigs, and has been tested in healthy people and found to be well tolerated and safe. The trial will involve making a scratch wound on the skin of the hip of 60 adult burn patients at two burn unit sites, and treating one side with the drug and the other with a control or placebo. Measurements will be taken once per month for four months, and patients will be asked to answer a scar assessment form.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I do not have severe lung damage, kidney failure needing dialysis, or unstable blood pressure needing strong medicine.My kidney function is very low (eGFR <= 30 mL/min).I do not have any health conditions that could affect wound healing.My BMI is between 15 and 35.I do not have a chronic or active skin condition that could affect wound healing.I have had radiation therapy on the scar that is being studied.I understand the study, can follow its procedures, and will attend all required visits.I am over 65, have epilepsy, urinary retention, or take certain medications.I have scars, tattoos, or birthmarks near the treatment area.I am between 18 and 65 years old with severe burns but have healthy skin on my hips.I have early-stage skin or other cancer that is being properly managed.
- Group 1: Placebo
- Group 2: Nefopam
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has Nefopam been granted clearance by the FDA?
"Nefopam's safety profile is evaluated as a 2 because this Phase 2 trial has only yielded evidence of its safety, with no data confirming efficacy."
What are the desired outcomes of this research endeavor?
"The primary objective of this research is to evaluate the efficacy of a new treatment by measuring scar/wound area at day 104. Secondary objectives include assessing respiration and routine hematology parameters, as well as serum Nefopam absorption assessment which will be performed on the first five patients prior to drug administration, 8 hours after initiation, and 24 hours after initiation. Digital photography of the wound/scar will also take place at day 1. Data from these assessments will be presented in mean value with variance format."
To what extent have people enrolled in this research endeavor?
"Correct. Clinicaltrials.gov reveals that, having been originally posted on July 10th 2022 and recently updated on September 9th 2022, this medical research is actively recruiting participants. Sixty individuals must be recruited from a single site to ensure the study's success."
Are there any additional studies of Nefopam in a clinical setting?
"At present, there are 5 active investigations into Nefopam's efficacy with none of them having reached Phase 3. Out of these trials, 5 have been based in Edmonton, Alberta."
Who fulfills the criteria for participation in this research endeavor?
"This clinical trial is looking to enrol 60 individuals between the ages of 18 and 65, who have sustained burn injuries. To be eligible for this study, participants must possess competency with English language comprehension; they should not possess a stage 1 carcinoma on any skin or tissue unless it has been adequately managed; their ALT & AST levels must be below twice the upper limit of normal (ULN) as well as TB measurements being under ULN at screening; healthy subjects need to provide a negative pregnancy serum/urine test result at time of screening and agree to abide by an effective method of birth control throughout the duration of the experiment;"
Is enrollment currently open for this experiment?
"According to clinicaltrials.gov, the recruitment phase for this medical trial is ongoing and was originally posted on July 10th 2022, with a most recent update occurring September 9th 2022."
Is this medical experiment enrolling individuals aged 40 or older?
"The inclusion parameters for this medical trial necessitate that participants are between 18 and 65 years old. There are 19 studies available to those younger than 18 and 62 trials dedicated to individuals over the age of 65."
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