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Safety of Topical Exosome-Containing Liquid in Healthy Volunteers for Future Surgical Wound Use
Sponsor: West Kazakhstan Marat Ospanov Medical University
Summary
This Phase 1 split-site pilot study will evaluate the safety and dermal tolerability of a topical exosome-containing liquid in 10 healthy adult volunteers. The investigational liquid will be applied to a small defined area of intact skin. A vehicle liquid without exosomes may be applied to a matched contralateral skin site as a control. The study will assess local skin reactions, systemic adverse events, vital signs, clinical laboratory parameters, and feasibility of topical administration. No melanoma lesion, surgical wound, burn wound, or artificial skin wound will be induced in participants in this Phase 1 safety study.
Official title: A Phase 1 Split-Site Pilot Study to Evaluate the Safety and Dermal Tolerability of Topical Exosome-Containing Liquid in Healthy Adult Volunteers Before Future Testing in Post-Melanoma-Excision Surgical Wounds
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2026-09
Completion Date
2027-01
Last Updated
2026-07-16
Healthy Volunteers
Yes
Conditions
Interventions
Exosome-Containing Liquid
The investigational product is a sterile topical liquid containing exosome-enriched extracellular vesicles derived from human umbilical cord-derived mesenchymal stromal cells. The liquid will be applied topically to a small defined area of intact skin at a dose of 0.1 mL/cm², containing 1 × 10\^10 extracellular vesicle particles/mL, equivalent to 1 × 10\^9 extracellular vesicle particles/cm², according to the approved protocol-defined schedule. The product is investigational and is being evaluated for safety and dermal tolerability before future testing in patients with postoperative wounds after melanoma excision.
Vehicle Liquid
Vehicle liquid without exosomes will be applied topically to a matched contralateral intact skin site according to the same protocol-defined schedule as the exosome-containing liquid. The vehicle liquid is used as a within-participant control for local dermal tolerability assessment.
Locations (1)
ATMP center of West Kazakhstan Marat Ospanov Medical University
Aktobe, Aktobe, Kazakhstan