Safety of Topical Exosome-Containing Liquid in Healthy Volunteers

NCT07703969 | Not Yet Recruiting Phase 1 DMC

• 2 other identifiers: WKMU-EV-SAFE-001IRN BR25593457
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Irritation; Healthy Volunteers

Keywords

exosomes; extracellular vesicles; topical exosome-containing liquid; healthy volunteers; dermal safety; skin tolerability; skin irritation; phase 1; first-in-human; burn wound development; mesenchymal stromal cell-derived extracellular vesicles; dermal tolerability

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events

  Number of participants with any treatment-emergent adverse event after topical application of the exosome-containing liquid. Events include local application-site reactions such as erythema, edema, pruritus, burning sensation, pain, rash, vesicles, ulceration, allergic reaction, or infection, and systemic events such as fever, malaise, abnormal vital signs, clinically significant laboratory abnormalities, serious adverse events, or any other clinically significant adverse event judged by the investigator.

  From first application through Day 28

Secondary Outcomes (6)

• Maximum Total Score on the Draize Dermal Irritation Scale at the Exosome-Containing Liquid Application Site

  Baseline, 30 minutes, 24 hours, 48 hours, 72 hours, Day 7, Day 14, and Day 28

• Within-Participant Difference in Total Draize Dermal Irritation Scale Score Between Exosome-Containing Liquid and Vehicle-Control Sites

  Baseline, 30 minutes, 24 hours, 48 hours, 72 hours, Day 7, Day 14, and Day 28

• Number of Participants With Clinically Significant Vital Sign Abnormalities

  From first application through Day 28

• Number of Participants With Clinically Significant Clinical Laboratory Abnormalities

  From first application through Day 28

• Percentage of Planned Topical Applications Completed According to Protocol

  From Day 0 through Day 14

Study Arms (1)

Exosome-Containing Liquid and Vehicle-Control Skin Sites

EXPERIMENTAL

Healthy adult volunteers will receive topical exosome-containing liquid applied to a small defined area of intact skin. In the split-site design, vehicle liquid without exosomes will be applied to a matched contralateral intact skin site as a control. No burn wound or artificial skin wound will be induced.

Biological: Exosome-Containing Liquid; Other: Vehicle Liquid

Interventions

Exosome-Containing Liquid BIOLOGICAL

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.

Also known as: Extracellular vesicle-containing liquid, EV-containing liquid, Exosome-enriched extracellular vesicle liquid, MSC-derived extracellular vesicle liquid

Exosome-Containing Liquid and Vehicle-Control Skin Sites

Vehicle Liquid OTHER

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.

Also known as: Vehicle control liquid, Liquid without exosomes

Exosome-Containing Liquid and Vehicle-Control Skin Sites

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult volunteers aged 18 to 55 years.
• Able and willing to provide written informed consent.
• No clinically significant abnormality based on medical history, physical examination, vital signs, and screening laboratory tests.
• Intact healthy skin at the planned application sites.
• Willingness to avoid applying other topical products, cosmetics, antiseptics, or irritant substances to the application sites during the study period.
• Willingness to avoid excessive sun exposure, sauna, swimming pool use, and mechanical irritation of the application sites during the study period.
• Willingness to comply with all study visits, topical application procedures, local skin assessments, skin photography, safety assessments, and follow-up.
• For women of childbearing potential, a negative pregnancy test before first application and willingness to use an acceptable method of contraception during the study period.

You may not qualify if:

• Any active skin disease, dermatitis, eczema, psoriasis, urticaria, acneiform eruption, skin infection, open wound, scar, tattoo, burn scar, pigmentation disorder, or clinically significant skin abnormality at the planned application sites.
• History of severe allergy, anaphylaxis, or hypersensitivity to topical liquids, dressings, biological products, exosome-containing products, or any component of the investigational product or vehicle liquid.
• Current acute illness, fever, or active infection.
• Known autoimmune disease, immunodeficiency, or current systemic immunosuppressive therapy.
• Use of systemic corticosteroids, immunomodulatory drugs, biological agents, or investigational products within 30 days before enrollment.
• Use of topical corticosteroids, topical immunomodulators, topical antibiotics, retinoids, keratolytic agents, or other medicated topical products on or near the planned application sites within 14 days before enrollment.
• Clinically significant hepatic, renal, cardiovascular, hematologic, endocrine, neurologic, psychiatric, or systemic disease that may increase risk or interfere with interpretation of study results.
• Known active malignancy or history of malignancy within the past 5 years.
• Positive screening test for clinically relevant transmissible infection, if required by the protocol.
• Pregnancy or breastfeeding.
• Positive pregnancy test at screening or before first application in women of childbearing potential.
• Participation in another interventional clinical trial within 30 days before enrollment.
• Blood donation or major blood loss within 30 days before enrollment, if laboratory safety monitoring is included in the protocol.
• Any condition that, in the investigator's judgment, would make participation unsafe or interfere with interpretation of study results.

Sponsors & Collaborators

• West Kazakhstan Marat Ospanov Medical University: lead

Study Sites (1)

ATMP center of West Kazakhstan Marat Ospanov Medical University

Aktobe, Aktobe, 030012, Kazakhstan

Location

Related Publications (4)

• Wang M, Xu X, Lei X, Tan J, Xie H. Mesenchymal stem cell-based therapy for burn wound healing. Burns Trauma. 2021 May 1;9:tkab002. doi: 10.1093/burnst/tkab002. eCollection 2021.

  PMID: 34212055 BACKGROUND

• Manzoor T, Farooq N, Sharma A, Shiekh PA, Hassan A, Dar LA, Nazir J, Godha M, Sheikh FA, Gugjoo MB, Saleem S, Ahmad SM. Exosomes in nanomedicine: a promising cell-free therapeutic intervention in burn wounds. Stem Cell Res Ther. 2024 Oct 9;15(1):355. doi: 10.1186/s13287-024-03970-3.

  PMID: 39385310 BACKGROUND

• Hu JC, Zheng CX, Sui BD, Liu WJ, Jin Y. Mesenchymal stem cell-derived exosomes: A novel and potential remedy for cutaneous wound healing and regeneration. World J Stem Cells. 2022 May 26;14(5):318-329. doi: 10.4252/wjsc.v14.i5.318.

  PMID: 35722196 BACKGROUND

• Welsh JA, Goberdhan DCI, O'Driscoll L, Buzas EI, Blenkiron C, Bussolati B, Cai H, Di Vizio D, Driedonks TAP, Erdbrugger U, Falcon-Perez JM, Fu QL, Hill AF, Lenassi M, Lim SK, Mahoney MG, Mohanty S, Moller A, Nieuwland R, Ochiya T, Sahoo S, Torrecilhas AC, Zheng L, Zijlstra A, Abuelreich S, Bagabas R, Bergese P, Bridges EM, Brucale M, Burger D, Carney RP, Cocucci E, Crescitelli R, Hanser E, Harris AL, Haughey NJ, Hendrix A, Ivanov AR, Jovanovic-Talisman T, Kruh-Garcia NA, Ku'ulei-Lyn Faustino V, Kyburz D, Lasser C, Lennon KM, Lotvall J, Maddox AL, Martens-Uzunova ES, Mizenko RR, Newman LA, Ridolfi A, Rohde E, Rojalin T, Rowland A, Saftics A, Sandau US, Saugstad JA, Shekari F, Swift S, Ter-Ovanesyan D, Tosar JP, Useckaite Z, Valle F, Varga Z, van der Pol E, van Herwijnen MJC, Wauben MHM, Wehman AM, Williams S, Zendrini A, Zimmerman AJ; MISEV Consortium; Thery C, Witwer KW. Minimal information for studies of extracellular vesicles (MISEV2023): From basic to advanced approaches. J Extracell Vesicles. 2024 Feb;13(2):e12404. doi: 10.1002/jev2.12404.

  PMID: 38326288 BACKGROUND

MeSH Terms

Interventions

Fluid Therapy

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Nadiar M Mussin, PhD

CONTACT

+7 777 297 8901; nadiar_musin@zkmu.kz

Amin Tamadon, PhD

CONTACT

+7 705 629 9350; tamadon@zkmu.kz

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a Phase 1 single-group split-site pilot study in 10 healthy adult volunteers. Each participant will receive topical exosome-containing liquid on a small defined area of intact skin. If the split-site vehicle-controlled design is implemented, vehicle liquid without exosomes will be applied to a matched contralateral intact skin site. No burn wound or artificial skin wound will be induced. The study is designed to evaluate local and systemic safety and dermal tolerability before future clinical testing in patients with burn wounds.

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 15, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)