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Recruiting NCT05830968

Safety and Efficacy of Radio Frequency for the Treatment of Mild to Severe Inflammatory Acne

Trial Parameters

Condition Inflammatory Acne Vulgaris
Sponsor InMode MD Ltd.
Study Type INTERVENTIONAL
Phase N/A
Enrollment 42
Sex ALL
Min Age 16 Years
Max Age N/A
Start Date 2023-05-01
Completion 2025-05-01
Interventions
Morpheus8 Applicator Radiofrequency device

Brief Summary

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

Eligibility Criteria

Inclusion Criteria: * Subject is \>16 years of age * General good health confirmed by medical history and examination of the treated area. * Subjects with mild to severe Acne Vulgaris, defined as a baseline IGA (Investigator's Global Assessment) score of 2, 3 or 4 and 10-100 inflammatory lesions (papules or pustules). * The patients should be willing to comply with the study procedure and schedule, including the follow up visits, and will refrain from using any other acne treatment methods during the entire study period. * Willing to avoid sun/UV exposure for duration of the study unless using sunscreen. * Willing to refrain from starting or changing hormonal contraception for duration of study. * Subject understands and is willing to sign the informed consent to participate in the study. Parental (or other) guardians must provide consent for minors under the age of 18. Exclusion Criteria:- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body

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