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The primary objective of this study is to determine the efficacy and longevity of the use of RestylaneĀ® and PerlaneĀ® in combination for the rejuvenation of the infraorbital hollows and to measure patient satisfaction with this treatment
This study will examine the effectiveness of using RestylaneĀ® and PerlaneĀ® together in the treatment of the hollows in the under eye area. The combination of these treatments for use in the under eye area is considered investigational. An investigational therapy is a therapy that is not approved by the US Food and Drug Administration (FDA). RestylaneĀ® and PerlaneĀ® has been approved for treatment of moderate to severe facial wrinkles and folds, such as nasolabial folds by the FDA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restalyne and Perlane | Experimental | One syringe of PerlaneĀ® (1.0cc) and one syringe of RestylaneĀ® (1.0cc) will be used total for both tear trough areas. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restalyne | Drug | one syringe of RestylaneĀ® (1.0cc) will be used total for both tear trough areas. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Objective of This Study is to Determine the Efficacy and Longevity of the Use of RestylaneĀ® and PerlaneĀ® in Combination for the Rejuvenation of the Infraorbital Hollows and to Measure Patient Satisfaction With This Treatment | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Tung, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Restalyne and Perlane | One syringe of PerlaneĀ® (1.0cc) and one syringe of RestylaneĀ® (1.0cc) will be used total for both tear trough areas. Restalyne and Perlane: One syringe of PerlaneĀ® (1.0cc) and one syringe of RestylaneĀ® (1.0cc) will be used total for both tear trough areas. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Principal Investigator left the institution and no data is available.
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| ID | Title | Description |
|---|---|---|
| BG000 | Restalyne and Perlane | One syringe of PerlaneĀ® (1.0cc) and one syringe of RestylaneĀ® (1.0cc) will be used total for both tear trough areas. Restalyne: one syringe of RestylaneĀ® (1.0cc) will be used total for both tear trough areas. Perlane: One syringe of PerlaneĀ® (1.0cc) will be used total for both tear trough areas. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | PI left institution no data is available. |
| 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 | The Primary Objective of This Study is to Determine the Efficacy and Longevity of the Use of RestylaneĀ® and PerlaneĀ® in Combination for the Rejuvenation of the Infraorbital Hollows and to Measure Patient Satisfaction With This Treatment | The Principle Investigator left the institution and no data is available. | Posted | 1 year |
|
|
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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 | Restalyne and Perlane | One syringe of PerlaneĀ® (1.0cc) and one syringe of RestylaneĀ® (1.0cc) will be used total for both tear trough areas. Restalyne and Perlane: One syringe of PerlaneĀ® (1.0cc) and one syringe of RestylaneĀ® (1.0cc) will be used total for both tear trough areas. |
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PI left institution, no data is available.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Tung, MD | Loyola Medicine | (708) 216-4962 | rtung@loyolamedicine.org |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| C502935 | Perlane |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Perlane | Drug | One syringe of PerlaneĀ® (1.0cc) will be used total for both tear trough areas. |
|
|
| Count of Participants |
| Participants |
|
| Sex/Gender, Customized | female only. PI left institution, no data is available. | PI left institution, no data is available. | Count of Participants | Participants |
|
| Participants |
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
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