NCT03855397

Brief Summary

A randomized, crossover, double-blind, placebo-controlled, one-session clinical trial with 30 male volunteers was performed to access pain and safety of microneedle topical application in different regions of the oral cavity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 29, 2019

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
Last Updated

February 26, 2019

Status Verified

January 1, 2019

Enrollment Period

4 months

First QC Date

January 29, 2019

Last Update Submit

February 25, 2019

Conditions

Oral Cavity Disease

Keywords

MicroneedlesBuccal mucosaTransbuccal administration

Outcome Measures

Primary Outcomes (2)

  • Pain sensitivity assessment by Visual Analogue Scale after microneedle application in the oral cavity

    Pain was evaluated after microneedles, hypodermic needle or negative control topical application application in different oral cavity sites

    30 seconds

  • Number of participants with treatment-related adverse events as assessed by visual inspection of ecchymosis, ulceration, redness, swelling or bleeding after microneedles use in the oral cavity

    Any sign of ecchymosis, ulceration, redness, swelling or bleeding right after and 24 h later applications of the devices in different oral cavity sites

    24 hours

Secondary Outcomes (1)

  • Confirmation of mucosal perforationin the oral cavity after application of the devices

    Right after microneedle application

Study Arms (1)

Microneedles

EXPERIMENTAL

Application of microneedle patch, 30G hypodermic needle (positive control) and flat patch (negative control) in the lip, buccal, tongue, palatal and gingival mucosa for pain and safety assessment

Other: MicroneedleOther: Hypodermic needleOther: Flat patch

Interventions

MicroneedleOTHER

A microneedle patch (no drug) was applied in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa to access pain, discomfort and safety.

Microneedles
Hypodermic needleOTHER

30 gauge hypodermic needle was inserted in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa.

Also known as: positive control
Microneedles
Flat patchOTHER

A flat patch was applied in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa.

Also known as: negative control
Microneedles

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Healthy male

You may not qualify if:

  • \- Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders, smokers or alcoholic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michelle Franz Montan Braga Leite

Piracicaba, São Paulo, 13414903, Brazil

Location

MeSH Terms

Conditions

Mouth Diseases

Interventions

PittCoVaccNeedles

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Michelle Leite, PhD

    University of Campinas, Brazil

    PRINCIPAL INVESTIGATOR

  • Harvinder S Gill, PhD

    Texas Tech University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 29, 2019

First Posted

February 26, 2019

Study Start

January 16, 2018

Primary Completion

May 25, 2018

Study Completion

December 16, 2018

Last Updated

February 26, 2019

Record last verified: 2019-01

Locations

BR(1)