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Safety of Topical Exosome-Containing Liquid in Healthy Volunteers for Future Surgical Wound Use (EV-MELSAFE)

12. Juli 2026 aktualisiert von: Amin Tamadon, West Kazakhstan Marat Ospanov Medical University

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

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

The investigational product is a sterile topical exosome-containing liquid being developed for future evaluation in postoperative skin wound repair after melanoma excision. Preclinical in vivo evaluation in a murine surgical post-melanoma-excision wound model suggested improved wound closure kinetics and better histological organization of repaired skin after topical exosome-containing formulation administration. In the surgical wound model, the exosome-containing formulation group showed a faster wound-area reduction trend, significant wound-area reduction at selected time points, improved epithelialization, more organized regenerated tissue, fewer tissue defect-associated spaces, and no significant body-weight differences compared with control groups.

This first-in-human Phase 1 study is designed to evaluate safety and dermal tolerability in healthy adult volunteers before the product is tested in patients with postoperative wounds after melanoma excision. No melanoma lesion, surgical wound, burn wound, or artificial skin wound will be created. The investigational liquid will be applied to a small defined area of intact skin according to the protocol-defined dose and schedule. If a split-site design is used, vehicle liquid without exosomes will be applied to a matched contralateral intact skin site as a control. Participants will be monitored for local skin irritation, erythema, edema, pruritus, burning sensation, pain, rash, allergic reaction, systemic adverse events, vital signs, and clinical laboratory abnormalities.

The first two participants will be enrolled as sentinel participants. Safety data through at least 72 hours after first application will be reviewed before enrollment of the remaining participants. The main purpose of the study is to determine whether topical administration of the exosome-containing liquid is safe and tolerable on intact human skin before future clinical evaluation in post-melanoma-excision surgical wound repair.

Studientyp

Interventionell

Einschreibung (Geschätzt)

10

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Kasachstan
    • Aktobe
      • Aktobe, Aktobe, Kasachstan, 030012
        • ATMP center of West Kazakhstan Marat Ospanov Medical University
        • Kontakt:
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

Inclusion Criteria:

  1. Healthy adult volunteers aged 18 to 55 years.
  2. Able and willing to provide written informed consent.
  3. No clinically significant abnormality based on medical history, physical examination, vital signs, and screening laboratory tests.
  4. Intact healthy skin at the planned application sites.
  5. Willingness to avoid applying other topical products, cosmetics, antiseptics, or irritant substances to the application sites during the study period.
  6. Willingness to avoid excessive sun exposure, sauna, swimming pool use, and mechanical irritation of the application sites during the study period.
  7. Willingness to comply with all study visits, topical application procedures, local skin assessments, skin photography, safety assessments, and follow-up.
  8. 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.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Current acute illness, fever, or active infection.
  4. Known autoimmune disease, immunodeficiency, or current systemic immunosuppressive therapy.
  5. Use of systemic corticosteroids, immunomodulatory drugs, biological agents, or investigational products within 30 days before enrollment.
  6. 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.
  7. Clinically significant hepatic, renal, cardiovascular, hematologic, endocrine, neurologic, psychiatric, or systemic disease that may increase risk or interfere with interpretation of study results.
  8. Known active malignancy or history of malignancy within the past 5 years.
  9. Positive screening test for clinically relevant transmissible infection, if required by the protocol.
  10. Pregnancy or breastfeeding.
  11. Positive pregnancy test at screening or before first application in women of childbearing potential.
  12. Participation in another interventional clinical trial within 30 days before enrollment.
  13. Blood donation or major blood loss within 30 days before enrollment, if laboratory safety monitoring is included in the protocol.
  14. Any condition that, in the investigator's judgment, would make participation unsafe or interfere with interpretation of study results.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Exosome-Containing Liquid and Vehicle-Control Skin Sites
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 melanoma lesion, surgical wound, burn wound, or artificial skin wound will be induced.
Sonstiges: 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.
Biologisch: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Treatment-Emergent Adverse Events
Zeitfenster: From first application through Day 28
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Maximum Total Score on the Draize Dermal Irritation Scale at the Exosome-Containing Liquid Application Site
Zeitfenster: Baseline, 30 minutes, 24 hours, 48 hours, 72 hours, Day 7, Day 14, and Day 28
The Draize Dermal Irritation Scale grades erythema and eschar formation from 0, indicating no erythema, to 4, indicating severe erythema or eschar formation, and edema from 0, indicating no edema, to 4, indicating severe edema. The total score is the sum of the erythema/eschar score and edema score and ranges from 0 to 8. Higher scores indicate worse local skin irritation. The maximum total score observed at the exosome-containing liquid application site will be reported.
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
Zeitfenster: Baseline, 30 minutes, 24 hours, 48 hours, 72 hours, Day 7, Day 14, and Day 28
The within-participant difference will be calculated as the total Draize Dermal Irritation Scale score at the exosome-containing liquid application site minus the total score at the vehicle-control liquid application site at each assessment time point. The total Draize score ranges from 0 to 8, with higher scores indicating worse local skin irritation. Positive values indicate higher irritation at the exosome-containing liquid site, and negative values indicate higher irritation at the vehicle-control site.
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
Zeitfenster: From first application through Day 28
Number of participants with any clinically significant abnormality in vital signs after topical application of the exosome-containing liquid. Vital signs include systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and body temperature. Clinical significance will be determined by the investigator using protocol-defined reference ranges and clinical judgment. The reporting unit is number of participants.
From first application through Day 28
Number of Participants With Clinically Significant Clinical Laboratory Abnormalities
Zeitfenster: From first application through Day 28
Number of participants with any clinically significant abnormality in clinical laboratory safety tests after topical application of the exosome-containing liquid. Laboratory safety tests include complete blood count, renal function tests, liver function tests, and inflammatory markers according to the protocol. Clinical significance will be determined by the investigator using protocol-defined reference ranges and clinical judgment. The reporting unit is number of participants.
From first application through Day 28
Number of Participants With Delayed Treatment-Emergent Adverse Events
Zeitfenster: From Day 29 through Day 56
Number of participants with delayed local or systemic treatment-emergent adverse events occurring after completion of the primary Day 28 safety assessment. Delayed events may include local skin reactions, allergic reactions, infection, abnormal vital signs, clinically significant laboratory abnormalities, serious adverse events, or any other clinically significant adverse event judged by the investigator.
From Day 29 through Day 56
Percentage of Planned Topical Applications Completed According to Protocol
Zeitfenster: From Day 0 through Day 7 or Day 14, according to the protocol-defined application schedule
For each participant, the topical application completion percentage will be calculated as the number of completed topical applications divided by the number of protocol-planned topical applications, multiplied by 100. The outcome will be reported as the mean percentage of planned topical applications completed across participants. A higher percentage indicates better feasibility of topical application.
From Day 0 through Day 7 or Day 14, according to the protocol-defined application schedule

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

West Kazakhstan Marat Ospanov Medical University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2026

Studienabschluss (Geschätzt)

1. Januar 2027

Studienanmeldedaten

Zuerst eingereicht

7. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. Juli 2026

Zuerst gepostet (Tatsächlich)

16. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • WKMU-EV-MELSAFE-001

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

No. Individual participant data will not be shared because this is a small Phase 1 first-in-human safety and dermal tolerability study in 10 healthy volunteers, and de-identified individual-level data may still carry a risk of participant re-identification. Aggregate study results, adverse event summaries, and protocol-defined outcome summaries may be reported in ClinicalTrials.gov and in peer-reviewed publications.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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