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The aim of this trial is to evaluate the safety and efficacy of the InMode RF Pro System with the Morpheus8 face tip (24 pins) applicator for the treatment of mild, moderate and severe, facial acne vulgaris
The aim of this trial is to evaluate the safety and efficacy of the InMode RF Pro System with the Morpheus8 face tip (24 pins) applicator for the treatment of mild, moderate and severe, facial acne vulgaris. Prospective, multicenter clinical study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device treatment | Experimental | Treatment area will include affected areas over the entire face (presence of comedones, pustules, papules, nodules and cysts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morpheus8 Applicator Radiofrequency device | Device | Eligible subjects will receive 2 treatments with the Morpheus8 according to the study protocol. All participants will return for 2 follow up visits: 4 weeks (1M FU) and 12 weeks (3M FU) after the 2nd treatment. Total expected study duration is ~6 months, depending on subject recruitment rate. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of responder | Percent of responders, where responders are defined as subjects with at least a 50% reduction in number of inflammatory acne lesions from baseline to 12 weeks after the last treatment, as assessed by 3 independent reviewers using clinical photographs. Success Criteria: Success will be achieved if at least 50% of enrolled subjects are responders. | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in number of inflammatory acne lesions | Absolute change in number of inflammatory acne lesions from baseline to 12 weeks after the last treatment, as assessed by 3 independent reviewers using clinical photographs | Month 3 |
| Percentage of subjects with a ≥2 point score improvement on the Investigators Global Assessment (IGA) scale |
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Inclusion Criteria:
Exclusion Criteria:- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meital Matalon, MS | Contact | 9492588870 | 324 | meital.matalon@inmodemd.com |
| Maria Shusterman, RN | Contact | 9492396522 | 317 | maria.shusterman@inmodemd.com |
| Name | Affiliation | Role |
|---|---|---|
| Anna M Chapas, MD | Principal Investigator | |
| Jole L Cohen, MD | Unafilliated | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avant Dermatology Aesthetics | Recruiting | Oro Valley | Arizona | 85704 | United States |
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Study Design Prospective, multicenter clinical study
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|
Percentage of subjects with a ≥2 point score improvement on the Investigators Global Assessment (IGA) scale at 12 weeks after the last treatment compared to baseline as assessed by three independent reviewers using clinical photographs. |
| Month 3 |
| Absolute change in non-inflammatory acne lesions | Absolute change In non-inflammatory acne lesions from baseline to 12 weeks after the last treatment, as assessed by 3 independent reviewers from clinical photographs | Month 3 |
| The rate of patient satisfaction with treatment, | The rate of patient satisfaction with treatment, using a 5-point Likert scale at 12 weeks after the last treatment | Month 3 |
| percent change in non-inflammatory acne lesions | percent change in number of inflammatory acne lesions from baseline to 12 weeks after the last treatment, as assessed by 3 independent reviewers using clinical photographs | Month 3 |
| Percent change in non-inflammatory acne lesions | Percent change in non-inflammatory acne lesions from baseline to 12 weeks after the last treatment, as assessed by 3 independent reviewers from clinical photographs | Month 3 |
| AboutSkin Research, LLC | Active, not recruiting | Greenwood Village | Colorado | 80111 | United States |
| UnionDerm | Active, not recruiting | New York | New York | 10003 | United States |
| UT Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
|