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The purpose of this study is to evaluate the pain and safety in associated with injection of Restylane Perlane Lidocaine compared to Restylane Perlane using VAS scale
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane Perlane Lidocaine | Experimental | Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1 |
|
| Restylane Perlane | Active Comparator | Restylane Perlane will be injected into the opposite side of the nasolabial fold on day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Perlane Lidocaine | Device | Intradermal injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) | Subjects that reported at least 10 mm less VAS pain associated with injections of Perlane-Lido compared to Perlane 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. | At the time of injection |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) | Subjects that reported at least 10 mm less VAS pain associated with injections of Perlane-Lido compared to Perlane 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 right end. The distance in mm from the left end (no pain) to the participant's VAS mark is measured with a standard ruler. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Q-Med AB | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University | Kaohsiung City | Taiwan | ||||
| Chang Gung Memorial Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Restylane Perlane Lidocaine and Restylane Perlane | Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1 Restylane Perlane Lidocaine: Intradermal injection Restylane Perlane will be injected into the opposite side of the nasolabial fold on day 1 Restylane Perlane: Intradermal injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Restylane Perlane Lidocaine and Restylane Perlane | Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1 Restylane Perlane Lidocaine: Intradermal injection Restylane Perlane will be injected into the opposite side of the nasolabial fold on day 1 Restylane Perlane: 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 Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) | Subjects that reported at least 10 mm less VAS pain associated with injections of Perlane-Lido compared to Perlane 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 | At the time of injection |
|
Maximum 32 days for each participant (from screening visit to last visit).
AEs collection began after the informed consent form had been signed. Each subject was questioned about AEs at each clinical visit following the screening 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 | Restylane Perlane Lidocaine and Restylane Perlane | Restylane Perlane Lidocaine will be injected into one side of the nasolabial fold at day 1 Restylane Perlane Lidocaine: Intradermal injection Restylane Perlane will be injected into the opposite side of the nasolabial fold on day 1 Restylane Perlane: Intradermal injection |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Presyncope | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Reception | Galderma | +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 | Apr 13, 2017 | Jun 11, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 7, 2017 | Jun 11, 2019 | SAP_001.pdf |
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| Restylane Perlane |
| Device |
Intradermal injection |
|
| 15, 30, 45, and 60 minutes after injection |
| Taipei |
| Taiwan |
| Taipei Medical University Hospital | Taipei | Taiwan |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS) | Subjects that reported at least 10 mm less VAS pain associated with injections of Perlane-Lido compared to Perlane 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 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 | 15, 30, 45, and 60 minutes after injection |
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| 7 |
| 70 |
| Oral herpes | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Myofascial pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| after 60 minutes |
|