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Microneedle Patch Study in Healthy Infants/Young Children

NCT03207763 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2020-11-10

Study results available
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Summary

Microneedles can be prepared as a low-cost patch that is simple for patients to apply for vaccine delivery targeting the many antigen-presenting cells present in the skin. Data regarding the safety, reactogenicity, tolerability, and acceptability of a microneedle patch in children are lacking. The goal of this study is to evaluate the safety, reactogenicity, and acceptability of placement of a placebo microneedle patch to the skin of children.

Conditions

  • Vaccination
  • Skin Absorption

Interventions

DEVICE

Microneedle Formulation 1

Microneedle patches will be made of solid conical structures made of water-soluble excipients that from the Food and Drug Administration's Generally Recognized as Safe (GRAS) list and/or on the FDA list of inactive ingredients in approved products. The total mass of excipients delivered by placebo microneedle patch will be \<1.5 mg. The adhesive backing component is made from hypoallergenic material (commercial medical tapes designed to adhere to skin). Microneedle patches will be administered topically by manual application to the skin. The sites of microneedle patch application will be cleaned with an alcohol swab and allowed to dry before the microneedle patch is applied. The microneedle patches will be packaged and provided as single patches.

DEVICE

Microneedle Formulation 2

Microneedle patches will be made of solid conical structures made of water-soluble excipients that from the Food and Drug Administration's Generally Recognized as Safe (GRAS) list and/or on the FDA list of inactive ingredients in approved products. The ratio of the excipients and excipients used will vary slightly from Formulation 1. The total mass of excipients delivered by placebo microneedle patch will be \<1.5 mg. The adhesive backing component is made from hypoallergenic material (commercial medical tapes designed to adhere to skin). Microneedle patches will be administered topically by manual application to the skin. The sites of microneedle patch application will be cleaned with an alcohol swab and allowed to dry before the microneedle patch is applied. The microneedle patches will be packaged and provided as single patches.

Sponsors & Collaborators

  • Micron Biomedical, Inc

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Evan Anderson, MD · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
6 Weeks
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-11
Primary Completion
2019-05-15
Completion
2019-05-15
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03207763 on ClinicalTrials.gov