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

August 24, 2022 updated by: Galderma R&D

An Open, Multi-center Study Evaluating Efficacy, Safety and Injection Technique of Restylane Lip Products for Lip Enhancement and Lip Rejuvenation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Restylane Lip Volume is intended to be used for lip enhancement and Restylane Lip Refresh is intended to restore hydrobalance and improve skin structure of the lips (referred to as lip rejuvenation in this protocol), respectively. The lidocaine content is designed to reduce the subject's pain during treatment. The objectives of this open, multicenter study are to evaluate efficacy and safety of the products for the studied indications and to collect information on injection techniques used.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Göteborg, Sweden, 412 65
        • Göteborgs Plastikkirurgiska Center
      • Stockholm, Sweden, 115 42
        • Akademikliniken
      • Stockholm, Sweden, 111 44
        • Stureplanskliniken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 to 60 years of age.
  • Intent to undergo lip augmentation or rejuvenation of both the upper and lower lip.
  • Signed informed consent.

Exclusion Criteria:

  • Prior surgery or tattoo to the upper or lower lip or lip line.
  • Presence of any abnormal lip structure, such as a scar or lump or severe lip asymmetry.
  • A history of herpes labialis and an outbreak within four weeks of study entry or with four or more outbreaks in the 12 months prior to study entry.
  • Presence of facial hair that may interfere with efficacy evaluations.
  • Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster near or on the area to be treated.
  • History of angioedema.
  • Previous hypersensitivity to hyaluronic acid or local anesthetics.
  • Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation within 10 days prior to treatment, or a history of bleeding disorders.
  • Cancerous or pre-cancerous lesions in the area to be treated.
  • Previous tissue augmenting therapy in the area to be treated with hyaluronic acid (HA) or collagen filler, or laser treatment, during the last 12 months.
  • Permanent implant placed in the area to be treated or treatment with non-HA or non-collagen filler in the area to be treated.
  • Pregnancy or breast feeding.
  • Participation in any other clinical study within 30 days prior to inclusion.
  • Other condition preventing the subject to entering the study in the Investigator's opinion e.g. subjects not likely to avoid other facial cosmetic treatments below the level of the lower orbital rim, subjects anticipated to be unreliable or incapable of understanding the study assessment or unrealistic expectations of treatment result.
  • Study staff or close relative to study staff (e.g. parents, children, siblings or spouse).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Restylane Lip Volume
Submucosal injections with Restylane Lip Volume. Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and optional at week 2 and 12.
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.
Experimental: Restylane Lip Refresh
Submucosal injections with Restylane Lip Refresh. Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and optional at week 2 and 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 8 After Treatment
Time Frame: At week 8 - change of lips from baseline
To evaluate esthetic change of lips from baseline as judged by the subjects using GEIS. GEIS is a categorical scale with five levels: very much improved, much improved, somewhat improved, no change, worse.
At week 8 - change of lips from baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 36 After Treatment
Time Frame: week 36 - change from baseline
To evaluate esthetic change of lips from baseline as judged by the subjects using GEIS at week 36. GEIS is a categorical scale with five levels: very much improved, much improved, somewhat improved, no change, worse.
week 36 - change from baseline
GEIS (Global Esthetic Improvement Scale) Assessed by the Treating Investigator at Week 36 After Treatment
Time Frame: week 36 - change from baseline
To evaluate esthetic change of lips from baseline as judged by the treating investigator using GEIS at week 36. GEIS is a categorical scale with five levels: very much improved, much improved, somewhat improved, no change.
week 36 - change from baseline
GEIS (Global Esthetic Improvement Scale) Assessed by the Independent Evaluator at Week 36 After Treatment
Time Frame: week 36 - change from baseline
To evaluate esthetic change of lips from baseline as judged by the independent evaluator using GEIS at week 2, 4, 12, 26 and 36. GEIS is a categorical scale with five levels: very much improved, much improved, somewhat improved, no change, worse.
week 36 - change from baseline
MLFS (Medicis Lip Fullness Scale) at Week 8
Time Frame: week 8 - change from baseline
To evaluate the efficacy in terms of Medicis Lip Fullness Scale (MLFS) score by live assessment performed separately by the treating and the independent investigators in the Restylane Lip Volume group. The scale has five levels: Very thin, thin, median, full, very full. Treatment success is defined as at least one grade increase.
week 8 - change from baseline
Subject Satisfaction Questionnaire
Time Frame: Week 8

To evaluate subjects satisfaction in terms of a subject satisfaction questionnaire at week 8 after treatment.

The subject satisfaction questionnaire consists of questions regarding the looks, appearance, disomfort, and satisfaction regarding the treatment of the lips.

The question that will be referred to is: How satisfied are you today with (the look of) your lips ?
Week 8
Subject Diary for 14 Days After Initial Treatment
Time Frame: 2 weeks after initial treatment

To evaluate the acute safety profile (bruising, itching, pain, redness, swelling and tenderness) in terms of a 14-day subject diary after initial treatment.

Subjects still reporting one or more of the symptoms; bruising, itching, pain, redness, swelling and tenderness in the diary at day 14.
2 weeks after initial treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Galderma R&D

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ulf Samuelsson, Med Dr, Akademikliniken, Storängsvägen 10, 115 42 Stockholm
  • Principal Investigator: Dan Fagrell, Med Dr, Göteborgs Plastikirurgiska Center, Fridkullagatan 35 412 65 Göteborg
  • Principal Investigator: Pyra Haglund, Med Dr, Stureplanskliniken, Lästmakargatan 10, 111 44 Stockholm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 2, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 31GE1102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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