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Prospective, non-randomized, multi-center, pivotal clinical trial
This is a two-arm study. Eligible participants will receive up to three treatments with the Matrix Pro Applicator for lifting the eyebrow and/or improving lax tissue in the submental and neck areas. Treatments will be spaced approximately 6 weeks apart (± 2 weeks), and all participants will undergo follow-up evaluations at 1 month (± 2 weeks) and 3 months (± 2 weeks) after the final treatment.
Each investigational site will treat two areas: In arm 1, the upper face, including the forehead and peri-orbital area, to lift the eyebrows. In arm 2, the lower face, including the submental and neck areas, to lift lax tissue. Each patient could be assigned to both arms. Treatment may occur immediately after the screening and enrollment visit or at a later date, depending on site scheduling. Additional follow-up visits may be required at the investigator's discretion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zone 1: Eyebrow Lift | Experimental | Treatment of the upper face including treatment of forehead to mid cheek |
|
| Zone 2: Submentum and Neck | Experimental | Treatment of the lower face including mid to low cheek, submentum, and neck |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Matrix Pro | Device | Study subjects received up to three (3) study treatments with the Matrix Pro applicator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvements in lifting of lax tissue | as assessed by independent masked evaluators of pre and post treatment images | 3 months post last treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Candela Institute for Excellence | Marlborough | Massachusetts | 01752 | United States |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |