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This is a non-randomized, multi-center, open-label, prospective clinical trial evaluating clinical treatments with the Matrix Pro Applicator for the improvement of facial and/or submental and neck laxity.
Eligible participants will receive up to three treatments with the Matrix Pro Applicator of the Profound Matrix System to address facial and neck laxity. Treatments will be approximately 6 weeks apart (± 2 weeks). All participants will undergo follow-up evaluations at 1 month (4 weeks ± 2 weeks) and 3 months (13 weeks ± 2 weeks) after the final treatment. Additional follow-up visits may be required per Sponsor and PI discretion
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Matrix Pro Treatment Group | Experimental | Study subjects receive up to three (3) study treatments with the Matrix Pro applicator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Profound Matrix | Device | Treatment visits are limited to up to three (3) study treatments (with treatment intervals 6 weeks ± 2 weeks). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of change in facial, submentum, and neck laxity | Evaluation of change in facial, submentum, and neck laxity based on correct identification of subject's post-treatment photograph by at least 2 of the 3 independent blinded reviewers. | From subject enrollment to completion of 3-month follow-up visit, up to 32 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
Any of the following will exclude the subject from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Konika Schallen, MD | Candela Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kliniek voor Esthetische Geneeskunde | Amsterdam | EK | 1017 | Netherlands | ||
| Illuminate Skin & Wellness Clinic |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| D012871 | Skin Diseases |
| 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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| Kings Hill |
| Kent |
| ME19 4DG |
| United Kingdom |
| GHB Clinic | London | WC2H 9HE | United Kingdom |
| D017437 | Skin and Connective Tissue Diseases |