Clinical trial

Clinical Efficiency of Xanthan Hydrogels Containing Local Anesthetics Encapsulated in Nanostructured Lipid Carries

Name

CAAE: 45317521.9.0000.5418

Description

In a crossover, randomized, placebo-controlled, double-blind study, 40 volunteers will receive the following formulations: hydrogels containing LAs (local anesthetic) - lidocaine and prilocaine (both at 2.5%) encapsulated in CLN (XAN-CLN) or not (XAN-CLN ), EMLA (topical anesthetic available on the market) and placebo hydrogel. The formulations will be applied for 2 minutes, bilaterally on the palatal mucosa (first premolar region), in two distinct sessions. Soon after removal of the topical formulation, an AL will be performed at the region using 0.3 mL of anesthetic solution at an injection speed of 1 mL/min. Pain resulting from needle insertion and LA injection will be measured using two visual analog scales (VAS).

Trial arms

Trial start

2021-06-02

Estimated PCD

2022-02-20

Trial end

2022-05-03

Status

Completed

Phase

Early phase I

Treatment

Topical anesthetic

The topical anesthetic, or topical formulation, was applied to the palatal mucosa for 2 minutes.

Arms:

Topical anesthetic available on the market - Lidocaine (2.5%), Prilocaine (2.5%), Xanthan hydrogel (2%), Lidocaine (2.5%), Prilocaine (2.5%), Xanthan hydrogel (2%), Lidocaine (2.5%), Prilocaine (2.5%) in NLC, Xanthan hydrogel 2%

Other names:

Topical Formulation

Size

Primary endpoint

Pain sensitivity assessment by Visual Analogue Scale after the puncture of the needle of the local anesthetic.

2 minutes

Eligibility criteria

Inclusion Criteria: * Healthy participants * No lesions in the study area * Have already been submitted to local anesthesia without intercurrence Exclusion Criteria: * Used any drugs that change the pain sensibility 1 week before * Smokers * Alcoholic

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '40 volunteers will receive the following formulations: hydrogels containing LAs - lidocaine, and prilocaine (both at 2.5%) encapsulated in CLN (XAN-CLN) or not (XAN-CLN ), EMLA and placebo hydrogel. The formulations will be applied for 2 minutes, bilaterally on the palatal mucosa (first premolar region), in two distinct sessions. Soon after the removal of the topical formulation, an AL will be performed at the region using 0.3 mL of anesthetic solution at an injection speed of 1 mL/min. Pain resulting from needle insertion and LA injection will be measured using two visual analog scales (VAS).', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': "The participant and the applicator don't know which formulation was applied because these were named A, B, C, and D and the applicator doesn't have access to the data of which formulation was titled by each letter.", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}

Updated at

2023-06-22

1 organization

1 product

3 indications

Organization

University of Campinas

Product

Indication

Indication

Indication