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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
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.
Avant Dermatology Aesthetics
Oro Valley, Arizona, United States
RECRUITINGAboutSkin Research, LLC
Greenwood Village, Colorado, United States
ACTIVE_NOT_RECRUITINGUnionDerm
New York, New York, United States
ACTIVE_NOT_RECRUITINGPercent 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.
Time frame: Month 3
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
Time frame: Month 3
Percentage of subjects with a ≥2 point score improvement on the Investigators Global Assessment (IGA) scale
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.
Time frame: 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
Time frame: 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
Time frame: 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
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UT Southwestern Medical Center
Dallas, Texas, United States
RECRUITINGTime frame: 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
Time frame: Month 3