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This is a non-randomized, multi-center, open-label clinical trial evaluating the efficacy and clinical feasibility of the Profound Matrix device for electrocoagulation and for treatment of wrinkles and acne scars. Subjects will receive up to three (3) treatments with the Matrix Pro applicator or up to five (5) treatments with the Sublime and/or Sublative Radiofrequency (RF) applicators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Matrix Pro | Experimental | Subjects undergoing treatment with the Matrix Pro applicator. |
|
| Group 2: Sublime/Sublative | Experimental | Subjects undergoing treatment with either 1) Sublime applicator only, 2) Sublative RF applicator only, 3) Combined treatment of Sublime and Sublative RF applicators. |
|
| Modified Matrix Pro | Experimental | Subjects undergoing treatment with a Matrix Pro Modified applicator with lower RF power settings. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Profound Matrixâ„¢ System | Device | Study subjects will be treated with the Profound Matrix System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Aesthetic Improvement Scale (GAIS): Perceived Improvement in Overall Appearance | Perceived improvement in overall appearance according to the 5-point Global Aesthetic Improvement Scale from -1= Worse to 3= Very Much Improved as assessed by investigator at study endpoint | 3 months post final treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Global Aesthetic Improvement Scale (GAIS): Perceived Improvement in Overall Appearance | Perceived improvement in overall appearance according to the 5-point Global Aesthetic Improvement Scale from -1= Worse to 3= Very Much Improved as assessed by subject at study endpoint | 3 months post final treatment |
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Inclusion Criteria:
Exclusion Criteria:
bb. In the opinion of the Investigator, the subject is unwilling or unable to adhere to the study requirements
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| Name | Affiliation | Role |
|---|---|---|
| Konika Schallen, MD | Candela Medical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Candela Institue for Excellence | Marlborough | Massachusetts | 01752 | United States | ||
| NY Derm |
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| ID | Term |
|---|---|
| D006984 | Hypertrophy |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| New York |
| New York |
| 10028 |
| United States |
| OptiSkin | New York | New York | 10128 | United States |
| Laser & Vein Specialists of the Carolinas | Charlotte | North Carolina | 28207 | United States |
| Syneron Medical | Yokneam Illit | Israel |