Skin IrritationPhase 1EV-SAFE-1NCT07703969

Safety of Topical Exosome-Containing Liquid in Healthy Volunteers

A Phase 1 study testing Exosome-Containing Liquid in people with Skin Irritation and Healthy Volunteers, run by West Kazakhstan Marat Ospanov Medical University at 1 site in Kazakhstan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Skin Irritation, Healthy Volunteers
What is being tested?: Exosome-Containing Liquid
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteKazakhstan
Study dates: 25 Sep 2026to Dec 2026
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 14Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Kazakhstan1 site

ATMP center of West Kazakhstan Marat Ospanov Medical University
Aktobe, 030012

Other trials in Kazakhstan

About this 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

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.

Read the detailed description

The investigational product is a sterile topical exosome-containing liquid being developed for future evaluation in burn wound repair. Preclinical in vivo evaluation in murine wound models suggested improved wound closure and better histological organization of repaired skin after topical exosome-containing formulation administration, with the therapeutic effect being more pronounced in the thermal burn model. In the burn model, the exosome-containing formulation group showed faster wound-area reduction, improved epidermal and dermal organization, reduced inflammatory cellularity, 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 burn wounds. No artificial burn wound or 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.

Conditions: Skin Irritation, Healthy Volunteers
Being tested: Exosome-Containing Liquid, Vehicle Liquid
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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Exosome-Containing LiquidBiological
Also called Extracellular vesicle-containing liquid, EV-containing liquid, Exosome-enriched extracellular vesicle liquid, MSC-derived extracellular vesicle 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 LiquidOther
Also called Vehicle control liquid, Liquid without exosomes
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.

Study groups in NCT07703969
Study group	Role	What they receive
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. Receives: Biological: Exosome-Containing Liquid; Other: Vehicle Liquid

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: From first application through Day 28
Number of Participants With Clinically Significant Clinical Laboratory Abnormalities
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.
Measured: From first application through Day 28
Percentage of Planned Topical Applications Completed According to Protocol
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.
Measured: From Day 0 through Day 14
Number of Participants With Delayed Treatment-Emergent Adverse Events
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.
Measured: From Day 29 through Day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Sep 2026Dec 2026

First posted15 Jul 2026
Study start25 Sep 2026
Primary completionNov 2026 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Skin IrritationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Model description: 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.
Masking: None (open label)
Enrolment: 10 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07703969
Sponsor's protocol ID: WKMU-EV-SAFE-001
Other IDs: IRN BR25593457
Acronym: EV-SAFE-1
Status last verified: Oct 2026
First submitted: 7 Jul 2026
Last updated: 9 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Publications

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.
PubMed 34212055
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.
PubMed 39385310
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.
PubMed 35722196
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.
PubMed 38326288

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Active, not recruiting
Shaving Satisfaction in Males With Skin Irritation From Shaving
Pseudofolliculitis Barbae
Recruiting
IBS Skin Patch Test Food Allergy Study
Irritable Bowel Syndrome
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications

All Skin Irritation trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07703969
Acronym / sponsor ID: EV-SAFE-1 / WKMU-EV-SAFE-001
Conditions: Skin Irritation, Healthy Volunteers
Keywords: exosomes, extracellular vesicles, topical exosome-containing liquid, healthy volunteers, dermal safety, skin tolerability, skin irritation, phase 1
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 10 participants (estimated)
Lead sponsor: West Kazakhstan Marat Ospanov Medical UniversityUniversity, hospital or other
Study start: 25 Sep 2026 (actual)
Primary completion: Nov 2026 (estimated)
Study completion: Dec 2026 (estimated)
First posted: 15 Jul 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: 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.

Arm	Type	Receives
Exosome-Containing Liquid and Vehicle-Control Skin Sites	Experimental	Biological: Exosome-Containing Liquid, Other: Vehicle LiquidHealthy 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (14 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Exosome-Containing LiquidAlso: Extracellular vesicle-containing liquid, EV-containing liquid, Exosome-enriched extracellular vesicle liquid, MSC-derived extracellular vesicle liquidThe 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.	Biological	Exosome-Containing Liquid and Vehicle-Control Skin Sites
Vehicle LiquidAlso: Vehicle control liquid, Liquid without exosomesVehicle 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.	Other	Exosome-Containing Liquid and Vehicle-Control Skin Sites

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events
Time frame: 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.

6 secondary outcomes

Maximum Total Score on the Draize Dermal Irritation Scale at the Exosome-Containing Liquid Application Site
Time frame: 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
Time frame: 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
Time frame: From first application through Day 28
Number of Participants With Clinically Significant Clinical Laboratory Abnormalities
Time frame: From first application through Day 28
Percentage of Planned Topical Applications Completed According to Protocol
Time frame: From Day 0 through Day 14
Number of Participants With Delayed Treatment-Emergent Adverse Events
Time frame: From Day 29 through Day 56

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
Background: PubMed 34212055Wang 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.
Background: PubMed 39385310Manzoor 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.
Background: PubMed 35722196Hu 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.
Background: PubMed 38326288Welsh 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.
Individual participant dataSharing planned: No. 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.

Related trials for Skin Irritation

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Active, not recruiting
Shaving Satisfaction in Males With Skin Irritation From Shaving
Pseudofolliculitis Barbae
Recruiting
IBS Skin Patch Test Food Allergy Study
Irritable Bowel Syndrome
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Exosome-Containing Liquid in people with Skin Irritation and Healthy Volunteers, run by West Kazakhstan Marat Ospanov Medical University at 1 site in Kazakhstan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events (time frame: From first application through Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07703969, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.