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CompletedNCT01428024Updated Aug 26, 2022Results posted

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

An interventional study of Restylane Lip Volume and Restylane Lip Refresh in Injection Techniques, sponsored by Galderma R&D. Completed at 3 sites in Sweden. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-26.

Sponsored by Galderma R&D · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Injection Techniques

Keywords

  • efficacy
  • safety
  • Restylane
  • Lip products
  • injection techniques
03

In context

Lead sponsor

Galderma R&D is the lead sponsor of 280 studies on the registry; 9 are open to participants now.

Of its 59 completed or terminated interventional studies of FDA-regulated products, 55 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceRestylane Lip Volume

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

  • DeviceRestylane Lip Refresh

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At week 8 - change of lips from baseline

Secondary outcomes

  1. 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.

    Time frame: week 36 - change from baseline

  2. 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.

    Time frame: week 36 - change from baseline

  3. 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.

    Time frame: week 36 - change from baseline

  4. 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.

    Time frame: week 8 - change from baseline

  5. 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 ?

    Time frame: Week 8

  6. 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.

    Time frame: 2 weeks after initial treatment

07

Results

Posted Oct 18, 2018

Participant flow

Participant flow — Overall Study
MilestoneRestylane LipVolumeRestylane Lip Refresh
Started3030
Completed2929
Not completed11

Outcome measures

PrimaryGEIS (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.

Time frame:
At week 8 - change of lips from baseline
Reported as:
Number · percentage improved subjects
GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 8 After Treatment
percentage improved subjectsRestylane Lip VolumeRestylane Lip Refresh
GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 8 After Treatment86.2 (68.3 to 96.1)86.7 (69.3 to 96.2)
SecondaryGEIS (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.

Time frame:
week 36 - change from baseline
Reported as:
Number · percentage improved subjects
GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 36 After Treatment
percentage improved subjectsRestylane Lip VolumeRestylane Lip Refresh
GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 36 After Treatment93.1 (77.2 to 99.2)78.6 (59.0 to 91.7)
SecondaryGEIS (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.

Time frame:
week 36 - change from baseline
Reported as:
Number · percentage improved subjects
GEIS (Global Esthetic Improvement Scale) Assessed by the Treating Investigator at Week 36 After Treatment
percentage improved subjectsRestylane LipVolumeRestylane Lip Refresh
GEIS (Global Esthetic Improvement Scale) Assessed by the Treating Investigator at Week 36 After Treatment82.8 (64.2 to 94.2)82.8 (64.2 to 94.2)
SecondaryGEIS (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.

Time frame:
week 36 - change from baseline
Reported as:
Number · percentage improved subjects
GEIS (Global Esthetic Improvement Scale) Assessed by the Independent Evaluator at Week 36 After Treatment
percentage improved subjectsRestylane LipVolumeRestylane Lip Refresh
GEIS (Global Esthetic Improvement Scale) Assessed by the Independent Evaluator at Week 36 After Treatment86.2 (68.3 to 96.1)86.2 (68.3 to 96.1)
SecondaryMLFS (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.

Time frame:
week 8 - change from baseline
Reported as:
Number · percentage improved subjects
MLFS (Medicis Lip Fullness Scale) at Week 8
percentage improved subjectsRestylane LipVolume
MLFS (Medicis Lip Fullness Scale) at Week 850.0 (31.3 to 68.7)
SecondarySubject 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 ?

Time frame:
Week 8
Reported as:
Number · percentage satisfied subjects
Subject Satisfaction Questionnaire
percentage satisfied subjectsRestylane LipVolumeRestylane Lip Refresh
Subject Satisfaction Questionnaire9387
SecondarySubject 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.

Time frame:
2 weeks after initial treatment
Reported as:
Number · participants
Subject Diary for 14 Days After Initial Treatment
participantsRestylane Lip VolumeRestylane Lip Refresh
Subject Diary for 14 Days After Initial Treatment26

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Restylane LipVolume—3/30 (10%)16/30 (53.3%)
Restylane Lip Refresh—0/30 (0%)21/30 (70%)
Most frequent serious events
Most frequent serious events
EventRestylane LipVolumeRestylane Lip Refresh
Knee joint injuryMusculoskeletal and connective tissue disorders1/300/30
Viral encephalitisInfections and infestations1/300/30
CholecystitisHepatobiliary disorders1/300/30
Worsening of benign neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/300/30
Most frequent other events
Most frequent other events
EventRestylane LipVolumeRestylane Lip Refresh
Implant site haematomaGeneral disorders5/309/30
Implant site massGeneral disorders7/307/30
Implant site swellingGeneral disorders2/307/30
Injection site painGeneral disorders3/301/30
Implant site haemorrhageGeneral disorders1/303/30
Lip dryGastrointestinal disorders2/301/30
Implant site painGeneral disorders2/300/30
oral herpesInfections and infestations1/302/30
Blood blisterSkin and subcutaneous tissue disorders0/302/30
Implant site erythemaGeneral disorders0/302/30

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Restylane LipVolumeRestylane Lip RefreshTotal
<=18 years000
Between 18 and 65 years303060
>=65 years000
Age, Continuous
Age, Continuous(years)Restylane LipVolumeRestylane Lip RefreshTotal
Mean36.1 ± 12.549.4 ± 6.442.8 ± 11.9
Sex: Female, Male
Sex: Female, Male(Participants)Restylane LipVolumeRestylane Lip RefreshTotal
Female303060
Male000
Region of Enrollment
Region of Enrollment(participants)Restylane LipVolumeRestylane Lip RefreshTotal
Sweden303060
08

Study locations

3 sites
  • Göteborgs Plastikkirurgiska Center
    Göteborg, 412 65, Sweden
  • Stureplanskliniken
    Stockholm, 111 44, Sweden
  • Akademikliniken
    Stockholm, 115 42, Sweden
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01428024
Lead sponsor
Galderma R&D
Responsible party
Sponsor
First posted
Sep 2, 2011
Start date
Sep 2011
Primary completion
Nov 2011
Completion
Jun 2012
Results posted
Oct 18, 2018
Last update
Aug 26, 2022

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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