Injection TechniquesNCT01428024
Study to Evaluate Efficacy, Safety and Injection Technique of Restylane Lip Volume and Restylane Lip Refresh
A study testing Restylane Lip Volume and Restylane Lip Refresh in people with Injection Techniques, run by Galderma R&D at 3 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Injection Techniques
- What is being tested?
- Restylane Lip Volume and Restylane Lip Refresh
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesSweden
- Study dates
- Sep 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 60 years of age.
- Intent to undergo lip augmentation or rejuvenation of both the upper and lower lip.
- Signed informed consent.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Göteborgs Plastikkirurgiska Center
Gothenburg, 412 65
Stureplanskliniken
Stockholm, 111 44
Akademikliniken
Stockholm, 115 42
About this study
Official title: 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.
Read the 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.
- Conditions
- Injection Techniques
- Being tested
- Restylane Lip Volume, Restylane Lip Refresh
- Keywords
- efficacy, safety, Restylane, Lip products, injection techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane Lip VolumeDevice
Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.
Restylane Lip RefreshDevice
Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.
| Study group | Role | What they receive |
|---|---|---|
| Restylane Lip Volume | Experimental | 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. Receives: Device: Restylane Lip Volume |
| Restylane Lip Refresh | Experimental | 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. Receives: Device: Restylane Lip Refresh |
What is being measured
The primary outcome is the main question the study is designed to answer.
GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 8 After Treatment
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.
Measured: At week 8 - change of lips from baseline
Secondary outcomes (6)
GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 36 After Treatment
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.
Measured: week 36 - change from baseline
GEIS (Global Esthetic Improvement Scale) Assessed by the Treating Investigator at Week 36 After Treatment
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.
Measured: week 36 - change from baseline
GEIS (Global Esthetic Improvement Scale) Assessed by the Independent Evaluator at Week 36 After Treatment
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.
Measured: week 36 - change from baseline
MLFS (Medicis Lip Fullness Scale) at Week 8
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.
Measured: week 8 - change from baseline
Subject Satisfaction Questionnaire
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 ?
Measured: Week 8
Subject Diary for 14 Days 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.
Measured: 2 weeks after initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Injection TechniquesStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulf Samuelsson, Med Dr, Principal investigator, Akademikliniken, Storängsvägen 10, 115 42 StockholmDan Fagrell, Med Dr, Principal investigator, Göteborgs Plastikirurgiska Center, Fridkullagatan 35 412 65 GöteborgPyra Haglund, Med Dr, Principal investigator, Stureplanskliniken, Lästmakargatan 10, 111 44 Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428024
- Sponsor's protocol ID
- 31GE1102
- Status last verified
- Nov 2013
- First submitted
- 31 Aug 2011
- Last updated
- 26 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multi-center Study Evaluating Efficacy, Safety and Injection Technique of Restylane Lip Products for Lip Enhancement and Lip Rejuvenation
- ClinicalTrials.gov ID
- NCT01428024
- Acronym / sponsor ID
- 31GE1102
- Conditions
- Injection Techniques
- Keywords
- efficacy, safety, Restylane, Lip products, injection techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 2 Sep 2011 (estimated)
- Results
- Posted 18 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restylane Lip Volume | Experimental | Device: Restylane Lip VolumeSubmucosal 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. |
| Restylane Lip Refresh | Experimental | Device: Restylane Lip RefreshSubmucosal 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 to 60 years of age.
- Intent to undergo lip augmentation or rejuvenation of both the upper and lower lip.
- Signed informed consent.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restylane Lip VolumeTreatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12. | Device | Restylane Lip Volume |
| Restylane Lip RefreshTreatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12. | Device | Restylane Lip Refresh |
Primary outcome
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.
6 secondary outcomes
GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 36 After Treatment
Time frame: 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
GEIS (Global Esthetic Improvement Scale) Assessed by the Independent Evaluator at Week 36 After Treatment
Time frame: week 36 - change from baseline
MLFS (Medicis Lip Fullness Scale) at Week 8
Time frame: week 8 - change from baseline
Subject Satisfaction Questionnaire
Time frame: Week 8
Subject Diary for 14 Days After Initial Treatment
Time frame: 2 weeks after initial treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulf Samuelsson, Med Dr principal investigator
Akademikliniken, Storängsvägen 10, 115 42 Stockholm
Dan Fagrell, Med Dr principal investigator
Göteborgs Plastikirurgiska Center, Fridkullagatan 35 412 65 Göteborg
Pyra Haglund, Med Dr principal investigator
Stureplanskliniken, Lästmakargatan 10, 111 44 Stockholm
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane Lip Volume and Restylane Lip Refresh in people with Injection Techniques, run by Galderma R&D at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 8 After Treatment (time frame: At week 8 - change of lips from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.