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Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment

NCT03799484 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-06-18

Study results available
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Summary

The purpose of this study is to determine whether there is a difference in clinical effect, duration of effect, level of discomfort and patient satisfaction in patients receiving topical anesthesia on one side of the forehead and petrolatum ointment on the other prior to Botulinum Toxin Type A administration for the treatment of forehead rhytides.

Conditions

  • Forehead Rhytides
  • Forehead Wrinkles

Interventions

DRUG

Botulinum toxin type A

Botulinum toxin type A will be administered to both sides

DRUG

2.5% lidocaine/2.5% prilocaine

2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead

DEVICE

petrolatum ointment

petrolatum ointment will be applied to one side of the forehead

Sponsors & Collaborators

  • Robert Cizik Eye Clinic

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Karina Richani-Reverol, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-04
Primary Completion
2019-06-14
Completion
2019-06-14
FDA Drug
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 NCT03799484 on ClinicalTrials.gov