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Safety of Topical Exosome-Containing Liquid in Healthy Volunteers
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 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
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2026-09-25
Completion Date
2026-12
Last Updated
2026-10-09
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 the dose specified in the approved study protocol and batch release certificate. The dose is defined as the application volume per skin area and extracellular vesicle particle concentration per milliliter, with the total applied dose calculated as particles per square centimeter of skin. The product is investigational and is being evaluated for safety and dermal tolerability before future testing in patients with burn wounds.
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, Kazakhstan