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This study evaluated the safety, tolerability, and efficacy of Nefopam cream compared with placebo (an inactive cream) in burn patients. People aged 18-65 with deep second- or third-degree burns covering 5-70% of their body surface could take part. The study was conducted in Phase 2 and is completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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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