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The purpose of this study is to determine the safety and efficacy of using Restylane Perlane compared to Restylane for correction of moderate to severe nasolabial folds (NLF) in a Chinese population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane Perlane | Experimental | Single injection and optional touch up injection with Restylane Perlane in NLF |
|
| Restylane | Active Comparator | Single injection and optional touch up injection with Restylane in NLF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Perlane | Device | Intradermal injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months | The Wrinkle Severity Rating Scale (WSRS) is a 5-graded scale with grades 1-5 ranging from absent (1) to extreme (5). A clinical significant improvement is defined as at least 1 grade improvement (lowering in grade). | 6 months |
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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 |
|---|---|---|---|---|---|---|
| Beijing | China | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Restylane Perlane in One NLF and Restylane in the Other NLF | Single injection and optional touch up injection with Restylane Perlane in one nasolabial fold (NLF) and single injection and optional touch up injection with Restylane in the other NLF (split-face design). Restylane Perlane: Intradermal injection Restylane: Intradermal injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Restylane Perlane in One NLF and Restylane in the Other NLF | Single injection and optional touch up injection with Restylane Perlane in one NLF and single injection and optional touch up injection with Restylane in the other NLF (split-face design). Restylane Perlane: Intradermal injection, 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 | Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months | The Wrinkle Severity Rating Scale (WSRS) is a 5-graded scale with grades 1-5 ranging from absent (1) to extreme (5). A clinical significant improvement is defined as at least 1 grade improvement (lowering in grade). | Split-face design; 100 participants received treatment with Restylane Perlane in one NLF and treatment with Restylane in the other NLF. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
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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 in One NLF and Restylane in the Other NLF | Single injection and optional touch up injection with Restylane Perlane in one NLF and single injection and optional touch up injection with Restylane in the other NLF (split-face design). Restylane Perlane: Intradermal injection, Restylane: Intradermal injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Multi organ failure, infection | Infections and infestations | Not related to study product or study product injection procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Not related to study product or study product injection procedure: Frequency Threshold > 5% |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Q-Med AB | +46184749000 | reception.seupp@galderma.com |
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| Restylane |
| Device |
Intradermal injection |
|
| Wuhan |
| China |
| Zhejiang | China |
| Participants |
|
| 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 | Count of Participants | Participants |
|
| WSRS score of either 3 on both sides or 4 on both sides as assessed by an Independent Evaluator | The Wrinkle Severity Rating Scale (WSRS) is a 5-graded scale with grades 1-5 ranging from absent (1) to extreme (5). A clinical significant improvement is defined as at least 1 grade improvement (lowering in grade). | Count of Participants | Participants |
|
Single injection and optional touch up injection with Restylane in NLF
Restylane: Intradermal injection
|
|
| 0 |
| 100 |
| 2 |
| 100 |
| 16 |
| 100 |
|
| Bladder lesion excision | Surgical and medical procedures | Not related to study product or study product injection procedure |
|
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| Upper respiratory tract infection | Infections and infestations | Not related to study product or study product injection procedure: Frequency Threshold > 5% |
|
| Implant site bruising | General disorders | Restylane Perlane: Intensity of related adverse event |
|
| Implant site bruising | General disorders | Restylane: Intensity of related adverse event |
|
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