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FDA Phase II IND Approval (Wound Healing)

Medregen has received IND approval for a phase II, proof of concept to study the Safety and Preliminary Efficacy of MRG-001 in Wound Healing in Abdominoplasty Patients (NCT05844527).

Surgical excisions are one of the most frequent cutaneous wounds. This study will compare the safety and preliminary efficacy of MRG-001 in pre-abdominoplasty surgical excisions and scar appearance in subjects undergoing elective abdominoplasty. Subjects will undergo surgical excisions (10 8mm full-thickness biopsy punch wounds and 10 3 cm incisional wounds) in the abdominoplasty area and will be treated with MRG-001 or placebo for 3 weeks. After 6 weeks, the excision area is harvested for analysis and the study is terminated and the abdominoplasty is performed.

The main is to evaluate the safety of MRG-001 in overweight/obese subjects requiring abdominoplasty and studying the preliminary pharmacodynamics in cutaneous wound healing.

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