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Study to Evaluate Efficacy, Safety and Injection Technique of Restylane Lip Volume and Restylane Lip Refresh

NCT01428024 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-08-26

Study results available
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Summary

The purpose of this study is to demonstrate the efficacy and safety of two new Restylane Lip products, Restylane Lip Volume and Restylane Lip Refresh, and to collect information on the injection technique.

Conditions

  • Injection Techniques

Interventions

DEVICE

Restylane Lip Volume

Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.

DEVICE

Restylane Lip Refresh

Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Principal Investigators

  • Ulf Samuelsson, Med Dr · Akademikliniken, Storängsvägen 10, 115 42 Stockholm

  • Dan Fagrell, Med Dr · Göteborgs Plastikirurgiska Center, Fridkullagatan 35 412 65 Göteborg

  • Pyra Haglund, Med Dr · Stureplanskliniken, Lästmakargatan 10, 111 44 Stockholm

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2011-11-30
Completion
2012-06-30

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 NCT01428024 on ClinicalTrials.gov