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This is an open-label study to assess safety using Restylane and Perlane in the correction of facial wrinkles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane and Perlane | Active Comparator | Restylane and Perlane administered by injection. Recommended volume of 6.0 mL. Injection on study day 1 with an optional touch up on study day 14. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane and Perlane | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local and Systemic Adverse Events | To examine the safety of Restylane and Perlane when used in the treatment of facial wrinkles and folds by identification of the point incidence of:
| 2-weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Sanstead, RN, BSN, CCRC | Medicis Global Services | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Call For Information | Coral Gables | Florida | 33146 | United States | ||
| Call For Information |
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| ID | Title | Description |
|---|---|---|
| FG000 | Perlane and Restylane | Perlane and Restylane used open label to correct peri-oral wrinkles |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Perlane and Restylane | Perlane and Restylane used open label to correct peri-oral wrinkles |
| 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 | Local and Systemic Adverse Events | To examine the safety of Restylane and Perlane when used in the treatment of facial wrinkles and folds by identification of the point incidence of:
| Primary object is to examine safety using descriptive statistics (frequency and percentage). Analysis was on the Intent to treat Population of all treated subjects, including those subjects for whom only incomplete data were available. No considerations (e.g. imputation) were made for missing data. | Posted | Number | percentage of participants | 2-weeks |
|
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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 | Perlane and Restylane | Perlane and Restylane used open label to correct peri-oral wrinkles |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruising | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Trials | Medicis R&D Clinical Research Department | ClinicalTrialsQuery@Medicis.com |
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| Dallas |
| Texas |
| 75254 |
| United States |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 20 |
| 20 |
| 20 |
| Tenderness | General disorders |
|
| Swelling | General disorders |
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| Redness | General disorders |
|
| Headache | Nervous system disorders |
|
| Discomfort | General disorders |
|
Researcher agree to submit to Medicis for Medicis' prior review and written approval, which approval shall not be unreasonably withheld, any written publication utilizing results or other data generated from this study at least ninety days, or, for abstracts, at least thirty days before such publication is presented or submitted for publication.