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Evaluate Efficacy, Safety & Subject Satisfaction of Pain Management With Pliaglis® Cream for Dermal Filler Injections

NCT00716443 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2022-08-23

Study results available
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Summary

Pliaglis® Cream versus compounded topical anesthetic for pain management during Restylane® injections for the correction of nasolabial folds.

Conditions

  • Nasolabial Folds

Interventions

DRUG

tetracaine 7% / lidocaine 7% cream (Pliaglis® Cream)

Apply tetracaine/lidocaine cream once on one side of the face prior to Restylane® injections

DRUG

benzocaine 20% / lidocaine 6% / tetracaine 4% ointment

apply benzocaine / lidocaine / tetracaine ointment once on the other side of the face prior to Restylane® injections

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Principal Investigators

  • Ronald W Gottschalk, MD · Galderma R&D

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2008-09-30
Completion
2008-09-30

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 NCT00716443 on ClinicalTrials.gov