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The purpose of this study is to evaluate the pain and safety associated with injections of Restylane Lidocaine compared to Restylane using a visual analogue scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane Lidocaine | Experimental | Restylane Lidocaine will be injected into one side nasolabial fold on Day 1 |
|
| Restylane | Active Comparator | Restylane will be injected into the opposite side nasolabial fold on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Lidocaine | Device | Intradermal injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Difference in Pain (Restylane Lidocaine Side - Restylane Side) as Measured by a Visual Analogue Scale(VAS) | Subjects that reported at least 10 mm less VAS pain associated with injections of Restylane-Lido compared to Restylane at the time of injection. VAS=Visual Analogue Scale. The VAS is a subjective scale to measure pain intensity. The participant is instructed to put a vertical mark, approximating the pain experienced during the procedure, on a 100 mm (millimeter) horizontal line labelled "no pain" at the left end and "the worst pain you can imagine" at the right end. The distance in mm from the left end (no pain) to the participant's VAS mark is measured with a standard ruler. | Up to 60 minutes after Injection on Day of Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Differences in Pain (Restylane Side - Restylane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) | Subjects that reported at least 10 mm less VAS pain associated with injections of Restylane-Lido compared to Restylane at 15, 30, 45 and 60 minutes after injection. VAS=Visual Analogue Scale. The VAS is a subjective scale to measure pain intensity. The participant is instructed to put a vertical mark, approximating the pain experienced during the procedure, on a 100 mm (millimeter) horizontal line labelled "no pain" at the left end and "the worst pain you can imagine" at the rig |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Q-Med AB | Shanghai | China |
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Total 70 subjects enrolled and each subject has 2 NLFs, in total 70 NLFs were injected with Rstylane, opposite 70 NLFs was Restylane Lido.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Restylane Lidocaine will be injected into one side of the nasolabial fold at day 1 Restylane Lidocaine: Intradermal injection Restylane will be injected into the opposite side of the nasolabial fold on day 1 Restylane: Intradermal injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Restylane Lidocaine will be injected into one side of the nasolabial fold at day 1 Restylane Lidocaine: Intradermal injection Restylane will be injected into the opposite side of the nasolabial fold on day 1 Restylane: Intradermal injection |
| 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 | Treatment Difference in Pain (Restylane Lidocaine Side - Restylane Side) as Measured by a Visual Analogue Scale(VAS) | Subjects that reported at least 10 mm less VAS pain associated with injections of Restylane-Lido compared to Restylane at the time of injection. VAS=Visual Analogue Scale. The VAS is a subjective scale to measure pain intensity. The participant is instructed to put a vertical mark, approximating the pain experienced during the procedure, on a 100 mm (millimeter) horizontal line labelled "no pain" at the left end and "the worst pain you can imagine" at the right end. The distance in mm from the left end (no pain) to the participant's VAS mark is measured with a standard ruler. | Posted | Number | 95% Confidence Interval | percentage of subjects | Up to 60 minutes after Injection on Day of Treatment |
|
Up to 2 weeks
Each subject was asked about AEs at each clinical visit. The question asked was "Since your last clinical visit have you had any health problems?". Information on AEs could also be obtained from signs and symptoms detected during each examination or from a laboratory test, observations by the study personnel, subject diaries or spontaneous reports from the subjects.
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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 | All Study Participants | Restylane Lidocaine will be injected into one side nasolabial fold on Day 1 Restylane Lidocaine: Intradermal injection Restylane will be injected into one side nasolabial fold on Day 1 Restylane: Intradermal injection |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Development | Q-Med AB | +46184749000 | reception.seupp@galderma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 15, 2016 | May 4, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 4, 2016 | May 4, 2023 | SAP_003.pdf |
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| Restylane |
| Device |
Intradermal injection |
|
| 15, 30, 45, and 60 minutes after injection |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Treatment Differences in Pain (Restylane Side - Restylane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) | Subjects that reported at least 10 mm less VAS pain associated with injections of Restylane-Lido compared to Restylane at 15, 30, 45 and 60 minutes after injection. VAS=Visual Analogue Scale. The VAS is a subjective scale to measure pain intensity. The participant is instructed to put a vertical mark, approximating the pain experienced during the procedure, on a 100 mm (millimeter) horizontal line labelled "no pain" at the left end and "the worst pain you can imagine" at the rig | Posted | Number | 95% Confidence Interval | percentage of subjects | 15, 30, 45, and 60 minutes after injection |
|
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| 0 |
| 70 |
| 0 |
| 70 |
| 8 |
| 70 |
| Food allergy | Immune system disorders | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Upper respiratory tract infection | Immune system disorders | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | Systematic Assessment | This contusion occurred on other parts of body but not nose side. |
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| Alanine aminotransferase increased | Investigations | Systematic Assessment |
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| Blood uric acid increased | Investigations | Systematic Assessment |
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| Transaminases abnormal | Investigations | Systematic Assessment |
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| Title | Measurements |
|---|---|
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| after 60 minutes |
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