Injection Techniques
Conditions
Keywords
efficacy, safety, Restylane, Lip products, injection techniques
Brief 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.
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.
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.
Sponsors
Galderma R&D
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 8 After Treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GEIS (Global Esthetic Improvement Scale) Assessed by the Treating Investigator at Week 36 After Treatment | 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. |
| GEIS (Global Esthetic Improvement Scale) Assessed by the Independent Evaluator at Week 36 After Treatment | 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. |
| GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 36 After Treatment | 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. |
| Subject Satisfaction Questionnaire | 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 ? |
| Subject Diary for 14 Days After Initial Treatment | 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. |
| MLFS (Medicis Lip Fullness Scale) at Week 8 | 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. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Restylane LipVolume Open label
Restylane Lip Volume : Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and week 12. | 30 |
| Restylane Lip Refresh Open label
Restylane Lip Refresh : Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and week 12. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Restylane Lip Refresh | Restylane LipVolume | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 30 Participants | 60 Participants |
| Age, Continuous | 49.4 years STANDARD_DEVIATION 6.4 | 36.1 years STANDARD_DEVIATION 12.5 | 42.8 years STANDARD_DEVIATION 11.9 |
| Region of Enrollment Sweden | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 30 Participants | 30 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 30 | 21 / 30 |
| serious Total, serious adverse events | 3 / 30 | 0 / 30 |
Outcome results
Primary
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
Population: One subject did not perform GEIS evaluation at the 8-week visit and withdrew consent after the visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restylane Lip Volume | GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 8 After Treatment | 86.2 percentage improved subjects |
| Restylane Lip Refresh | GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 8 After Treatment | 86.7 percentage improved subjects |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restylane Lip Volume | GEIS (Global Esthetic Improvement Scale) Assessed by the Independent Evaluator at Week 36 After Treatment | 86.2 percentage improved subjects |
| Restylane Lip Refresh | GEIS (Global Esthetic Improvement Scale) Assessed by the Independent Evaluator at Week 36 After Treatment | 86.2 percentage improved subjects |
Secondary
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
Population: Restylane Lip Volume: One subject withdrew consent after the 8-week visit and thus did not perform the GEIS evaluation at 36 weeks.~Restylane Lip Refresh: Two subjects did not perform the GEIS evaluation at 36 weeks.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restylane Lip Volume | GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 36 After Treatment | 93.1 percentage improved subjects |
| Restylane Lip Refresh | GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 36 After Treatment | 78.6 percentage improved subjects |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restylane Lip Volume | GEIS (Global Esthetic Improvement Scale) Assessed by the Treating Investigator at Week 36 After Treatment | 82.8 percentage improved subjects |
| Restylane Lip Refresh | GEIS (Global Esthetic Improvement Scale) Assessed by the Treating Investigator at Week 36 After Treatment | 82.8 percentage improved subjects |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restylane Lip Volume | MLFS (Medicis Lip Fullness Scale) at Week 8 | 50.0 percentage improved subjects |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restylane Lip Volume | Subject Diary for 14 Days After Initial Treatment | 2 participants |
| Restylane Lip Refresh | Subject Diary for 14 Days After Initial Treatment | 6 participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restylane Lip Volume | Subject Satisfaction Questionnaire | 93 percentage satisfied subjects |
| Restylane Lip Refresh | Subject Satisfaction Questionnaire | 87 percentage satisfied subjects |