Safety and Efficacy of MRG-001 in Wound Healing in Abdominoplasty Patients (NCT05844527) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of MRG-001 in Wound Healing in Abdominoplasty Patients
United States10 participantsStarted 2023-11-20
Plain-language summary
Surgical excisions are one of the most frequent cutaneous wounds. This study will compare the safety and preliminary efficacy of a novel fixed-dose combination drug MRG-001 in pre-abdominoplasty surgical excisions and scar appearance in subjects undergoing elective abdominoplasty.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent (which includes the Photographic Release Form and HIPAA) prior to performing any of the Screening Visit procedures.
✓. Outpatient, males and females between 18 to 55 years of age, inclusive, at the time of signing the ICF. Female subjects of childbearing potential must have a negative serum pregnancy test at Visit 1a (Study Part A) and 1b (Study Part B) and practice a reliable method of contraception throughout the study.
✓. Seeking or scheduled for standard elective abdominoplasty.
✓. Willing to undergo directed excisions under local anesthesia and follow-up prior abdominoplasty and to undergo all follow-up visits after abdominoplasty surgery.
✓. Nonsmokers (or other nicotine use) as determined by history (no nicotine use over the past 6 months) and by urine cotinine concentration (\< 200 ng/mL) at the Screening Visit and prior to admission.
✓. Generally, in good health with no clinically significant abnormalities as determined by medical, history, physical examination, 12-lead ECG and clinical laboratory tests.
✓. The following applies to female subjects of childbearing potential:
✓. Body mass index (BMI) between 25 and 35.0 kg/m2, inclusive, at the Screening Visit.
Exclusion criteria
✕. Participation in any other clinical trial of an experimental treatment or used an investigational drug within the past 30 days.
What they're measuring
1
To evaluate the preliminary effectiveness of MRG-001 treatment on tensile strength of the scars. The difference in Newton force will be compared between saline and MRG-001.
. Subject has a clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, hematological or psychiatric disorder(s) as determined by the Principal Investigator or designee.
✕. History of diabetes mellitus or an HbA1C greater than 5.7 percent.
✕. History of prior abdominal surgery or abdominal liposuction, cryolipolysis, focused ultrasound or other fat reduction procedures in or near the anterior abdomen within 12 months prior to screening.
✕. History of poor or delayed wound healing such as prior wound dehiscence, chronic wound or leg ulcer.
✕. History of or evidence of a genetic collagen disorder such as Ehlers-Danlos Syndrome.
✕. Operating Physician is unable to design an abdominoplasty incision area of at least 25 cm wide by 12 cm tall at the center of the fusiform.
✕. The presence of any abnormality of the skin within the area of the proposed abdominoplasty that, in the opinion of the PI, could interfere with the excision process or grading of the resultant surgical scar (e.g., striae gravidarum, striae distensae, excessive nevi, numerous seborrheic keratoses, tattoos, etc.).