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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Lip Volume | Device | Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At week 8 - change of lips from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 36 - change from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Göteborgs Plastikkirurgiska Center | Gothenburg | 412 65 | Sweden | |||
| Stureplanskliniken |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 optional at week 12. |
| FG001 | 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 optional at week 12. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Restylane Lip Refresh |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | One subject did not perform GEIS evaluation at the 8-week visit and withdrew consent after the visit | Posted | Number | 95% Confidence Interval | percentage improved subjects | At week 8 - change of lips from baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 optional at week 12. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Knee joint injury | Musculoskeletal and connective tissue disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lip dry | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Medical Affairs | Q-Med AB | + 46 (0) 18 4749000 | reception.SEUPP@galderma.com |
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| Restylane Lip Refresh | Device | Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12. |
|
| 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. |
| 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. | 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. | 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 ? | 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. | 2 weeks after initial treatment |
| Stockholm |
| 111 44 |
| Sweden |
| Akademikliniken | Stockholm | 115 42 | Sweden |
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Restylane Lip Refresh |
GEIS (Global Esthetic Improvement Scale)subject at 8 weeks (change from baseline). Injection with Restylane Lip Refresh (a Hyaluronic acid gel)with maximum 0.5 ml for each upper/lower lip. |
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage improved subjects | week 36 - change from baseline |
|
|
|
| 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. | Posted | Number | 95% Confidence Interval | percentage improved subjects | week 36 - change from baseline |
|
|
|
| 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. | Posted | Number | 95% Confidence Interval | percentage improved subjects | week 36 - change from baseline |
|
|
|
| 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. | Posted | Number | 95% Confidence Interval | percentage improved subjects | week 8 - change from baseline |
|
|
|
| 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 ? | Posted | Number | percentage satisfied subjects | Week 8 |
|
|
|
| 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. | Posted | Number | participants | 2 weeks after initial treatment |
|
|
|
| 3 |
| 30 |
| 16 |
| 30 |
| EG001 | 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 optional at week 12. | 0 | 30 | 21 | 30 |
| Viral encephalitis | Infections and infestations |
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| Cholecystitis | Hepatobiliary disorders |
|
| Worsening of benign neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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| Implant site haematoma | General disorders |
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| Implant site mass | General disorders |
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| Implant site pain | General disorders |
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| Implant site swelling | General disorders |
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| Injection site pain | General disorders |
|
| oral herpes | Infections and infestations |
|
| Blood blister | Skin and subcutaneous tissue disorders |
|
| Implant site erythema | General disorders |
|
| Implant site haemorrhage | General disorders |
|
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