NCT05267938

Microneedle Pretreatment as a Strategy to Improve the Effectiveness of Topical Anesthetics Formulations

Completed Phase 1 Last updated 21 March 2022

What this trial tests

Phase 1 trial testing Topical Anesthetic in Oral Cavity Disease in 30 participants. Completed in 30 January 2020.

Timeline

1 August 2019

Primary endpoint
30 October 2019

30 January 2020

Quick facts

Lead sponsor	University of Campinas, Brazil
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	other
Enrollment	30
Start date	1 August 2019
Primary completion	30 October 2019
Estimated completion	30 January 2020
Sites	1 location across Brazil

Drugs / interventions tested

• Topical Anesthetic — full drug profile →
• Local anesthetic

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, two-sessions clinical trial with 30 male volunteers was performed to access pain of local anesthesia after using a topical anesthetic associated or not with prior application of microneedles to the palatal mucosa region

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. From mechanism to applications: Advanced microneedles for clinical medicine.
   Yang Y, Sun H, Sun X, Wang Y, et al · · 2025 · cited 9× · PMID 40463395 · DOI 10.1016/j.bioactmat.2025.04.025
2. Microneedles enhance the efficacy of topical dental anesthesia in male subjects: a randomized controlled trial.
   Santos SDC, Moreira NCF, Abdalla HB, Augusto GGX, et al · · 2026 · PMID 42154829 · DOI 10.1590/1807-3107bor-2026.vol40.023
3. Research advances on protein-based microneedles for treatment of skin diseases: A review.
   Fan L, Yang X, Tan B, Gan D, et al · · 2026 · PMID 42099995 · DOI 10.1016/j.mtbio.2026.103157