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A Study of Treatment Preference During Cheek Contouring Comparing Restylane® SubQ With and Without the Addition of Lidocaine Hydrochloride

NCT01431755 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2022-09-22

Study results available
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Summary

The objectives of this study are to evaluate the pain-relieving effect and safety of adding lidocaine hydrochloride to Restylane SubQ and to evaluate the esthetic improvement obtained. The study products will be administered in the cheek.

Conditions

  • Facial Tissue Augmentation

Interventions

DEVICE

Restylane SubQ

Treatment with up to 2 ml of the product

DEVICE

Restylane SubQ Lidocaine

Treatment with up to 2 ml of the product

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Principal Investigators

  • Per Hedén, M.D. · Akademikliniken, Storängsvägen 10, 115 42 Stockholm

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2011-10-31
Completion
2012-10-31

Countries

  • Sweden

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 NCT01431755 on ClinicalTrials.gov