NCT03855397

Pain and Safety of Microneedles in Oral Cavity

Completed NA Last updated 26 February 2019

What this trial tests

NA trial testing Microneedle in Oral Cavity Disease in 30 participants. Completed in 16 December 2018.

Timeline

16 January 2018

Primary endpoint
25 May 2018

16 December 2018

Quick facts

Lead sponsor	University of Campinas, Brazil
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	30
Start date	16 January 2018
Primary completion	25 May 2018
Estimated completion	16 December 2018
Sites	1 location across Brazil

Drugs / interventions tested

• Microneedle
• Hypodermic needle
• Flat patch

Conditions studied

• Oral Cavity Disease — all drugs for Oral Cavity Disease →

Sponsor

University of Campinas, Brazil

Who can join

Adults 18 to 35, male only, with Oral Cavity Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A crossover clinical study to evaluate pain intensity from microneedle insertion in different parts of the oral cavity.
   Di Carla Santos S, Fávaro-Moreira NC, Abdalla HB, Augusto GGX, et al · · 2021 · cited 22× · PMID 33161036 · DOI 10.1016/j.ijpharm.2020.120050