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Post marketing study to assess the likelihood of hypertropic scarring, keloid formation and hyper- or hypopigmentation in patients with Fitzpatrick Skin Types IV, V, and VI receiving nasolabial fold treatment with Radiesse® Injectable Dermal Filler
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiesse | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiesse® Injectable Dermal Filler | Device | Calcium hydroxylapatite particles suspected in an aqueous based gel carrier |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment | Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely | 3 months |
| Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment | Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19708876 | Result | Marmur ES, Taylor SC, Grimes PE, Boyd CM, Porter JP, Yoo JY. Six-month safety results of calcium hydroxylapatite for treatment of nasolabial folds in Fitzpatrick skin types IV to VI. Dermatol Surg. 2009 Oct;35 Suppl 2:1641-5. doi: 10.1111/j.1524-4725.2009.01311.x. Epub 2009 Aug 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiesse Injectable Dermal Filler | Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiesse Injectable Dermal Filler | Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds |
| 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 | Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment | Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely | Posted | Nov 2009 | Number | Participants | 3 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 | Radiesse Injectable Dermal Filler | Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Redness | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merz Aesthetics, Inc. | Merz Aesthetics, Inc. | 650-286-4041 | clinicaltrials@merzaesthetics.com |
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| Chevy Chase |
| Maryland |
| United States |
| Ypsilanti | Michigan | United States |
| New York | New York | United States |
| Philadelphia | Pennsylvania | United States |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment | Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely | Posted | Nov 2009 | Number | participants | 6 months |
|
|
|
| 0 |
| 100 |
| 27 |
| 100 |
| Bruising | Skin and subcutaneous tissue disorders |
|
| Swelling | Skin and subcutaneous tissue disorders |
|
Sponsor reserves right to review/comment on manuscript intended for publication/presentation which presents trial data. No manuscripts may be submitted for publication without prior review/comment by Sponsor. Title, right to determine disposition of any copyrights, or copyrightable material, first produced/composed in the performance of this research shall remain with PI, provided that PI grants Sponsor irrevocable right to reproduce/translate/use all such copyrighted material for own purposes.