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NOT YET RECRUITING
NCT07703969
PHASE1

Safety of Topical Exosome-Containing Liquid in Healthy Volunteers

Sponsor: West Kazakhstan Marat Ospanov Medical University

View on ClinicalTrials.gov

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

Completion Date

2027-01

Last Updated

2026-07-15

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Exosome-Containing Liquid

The investigational product is a sterile topical liquid containing exosome-enriched extracellular vesicles derived from \[insert cell source, e.g., mesenchymal stromal cells\]. The liquid will be applied topically to a small defined area of intact skin at a dose of \[insert exact dose, e.g., X mL/cm² containing Y particles/mL, equivalent to Z particles/cm²\] according to the protocol-defined schedule. The product is investigational and is being evaluated for safety and dermal tolerability before future testing in patients with burn wounds.

OTHER

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