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Safety and Tolerability Study of MSC Exosome Ointment

NCT05523011 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-10-31

Study results available
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Summary

This phase 1 study aims to evaluate the safety and tolerability of the application of the MSC exosome ointment with repeated topical application on adult healthy subjects (TID from Day 1 to 20). The results of this study were to provide the first clinical information on the drug's safety and inform the selection of administration of exosome ointment to be evaluated in subsequent clinical studies. The endpoints included to assess the safety and tolerability of exosome ointment for topical application in healthy adult volunteers are:

* Frequency of treatment-emergent adverse events (TEAEs)
* The incidence rate of local skin responses (LSR, i.e., erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration, hyperpigmentation, hypopigmentation, and scarring) \[Time Frame: Days 1 and 21\]
* Changes from baseline in blood parameters (including hematology, chemistry, and other inflammation parameters such as C-reactive protein \[CRP\] and erythrocyte sedimentation rate \[ESR\]) \[Time Frame: Days 1 and 21\]

Conditions

Interventions

DRUG

Exosome ointment

100 µg MSC exosomes/g ointment

Sponsors & Collaborators

  • National University Hospital, Singapore

    collaborator OTHER

  • Paracrine Therapeutics Dermatology Pte. Ltd.

    lead INDUSTRY

Principal Investigators

  • Nisha Suyien Chandran, Dr. · National University Hospital, Singapore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-08
Primary Completion
2022-04-05
Completion
2022-04-05

Countries

  • Singapore

Study Locations

More Related Trials

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 NCT05523011 on ClinicalTrials.gov