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The purpose of this study is to determine the safety and efficacy of using Restylane Perlane to shape the nasal dorsum and/or nasal root in comparison with a no-treatment control group
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane Perlane | Experimental | Single injection of Restylane Perlane in nasal dorsum and/or nasal root |
|
| No-treatment control | No Intervention | No-treatment control group do not receive any treatment during the main study period |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Perlane | Device | Intradermal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Difference of Change in Volume (mL) at 6 Months After Baseline Versus Pre-treatment in the Nasal Dorsum/Nasal Root Between Restylane Perlane Treatment Group and No-treatment Control | The primary objective of the study was to evaluate the efficacy of Restylane Perlane in shaping the nasal dorsum and/or nasal root as compared to no-treatment control, by assessment of the primary endpoint:The change in volume will be measured using 3 D photography technique. The change in volume was calculated as the value at 6 months of treatment group compared with non-treatment group | 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 | Single injection of Restylane Perlane in nasal dorsum and/or nasal root Restylane Perlane: Intradermal injection |
| FG001 | No-treatment Control | No-treatment control group do not receive any treatment during the main study period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Restylane Perlane | Single injection of Restylane Perlane in nasal dorsum and/or nasal root Restylane Perlane: Intradermal injection |
| BG001 | No-treatment Control | No-treatment control group do not receive any treatment during the main study period |
| 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 Difference of Change in Volume (mL) at 6 Months After Baseline Versus Pre-treatment in the Nasal Dorsum/Nasal Root Between Restylane Perlane Treatment Group and No-treatment Control | The primary objective of the study was to evaluate the efficacy of Restylane Perlane in shaping the nasal dorsum and/or nasal root as compared to no-treatment control, by assessment of the primary endpoint:The change in volume will be measured using 3 D photography technique. The change in volume was calculated as the value at 6 months of treatment group compared with non-treatment group | Posted | Mean | Standard Error | mL | 6 months |
|
During study participation, up to 12 months.
Each subject was questioned about AEs at each clinical visit starting at the treatment visit, Visit 2. 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, observations by the study personnel, reactions recorded in the subject diary that were ongoing on Day 14 or spontaneous reports from the subjects during the study.
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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 | Single injection of Restylane Perlane in nasal dorsum and/or nasal root Restylane Perlane: Intradermal injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mixed hemorrhoids | Metabolism and nutrition 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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| Guangzhou |
| China |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
No-treatment control group do not receive any treatment during the main study period |
|
|
| 0 |
| 98 |
| 4 |
| 98 |
| 0 |
| 98 |
| EG001 | No-treatment Control | No-treatment control group do not receive any treatment during the main study period | 0 | 33 | 1 | 33 | 0 | 33 |
| Solid pseudopapillary tumor of the pancreas | Hepatobiliary disorders | Systematic Assessment |
|
| Fallopian tube obstruction | Reproductive system and breast disorders | Systematic Assessment |
|
| peritoneal adhesions | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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