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Safety of Topical Exosome-Containing Liquid in Healthy Volunteers for Future Surgical Wound Use

NCT07707986 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-07-16

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

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.

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.

Sponsors & Collaborators

  • West Kazakhstan Marat Ospanov Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2026-12-31
Completion
2027-01-31

Countries

  • Kazakhstan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07707986 on ClinicalTrials.gov