Clinical Evaluation of Safety and Efficacy of the InMode RF Pro System With the Morpheus8 Applicator for the Treatment of Mild to Severe Inflammatory Acne Vulgaris

InMode MD Ltd.4 sites in 1 country42 target enrollmentMay 1, 2023

ConditionsInflammatory Acne Vulgaris

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Inflammatory Acne Vulgaris
Sponsor: InMode MD Ltd.
Enrollment: 42
Locations: 4
Primary Endpoint: Percent of responder
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Detailed Description

Registry

clinicaltrials.gov

Start Date

May 1, 2023

End Date

May 1, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

InMode MD Ltd.

Responsible Party

Sponsor

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.
•Patients who are under pharmacological anti-acne therapy (isotretinoin or antibiotics) for the last 6 months.
•Use of botulinum toxin within prior 1 month.
•Permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance
•Current or history of cancer, or premalignant condition in the treatment area.
•Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
•Subject who are pregnant or nursing.
•Started or changed hormonal contraceptive within prior month of study.
•Subject is unwilling or unlikely to refrain from high UV exposure to face.
•Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.

Outcomes

Primary Outcomes

Percent of responder

Time Frame: Month 3

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.

Secondary Outcomes

percent change in non-inflammatory acne lesions(Month 3)
Absolute change in number of inflammatory acne lesions(Month 3)
Absolute change in non-inflammatory acne lesions(Month 3)
The rate of patient satisfaction with treatment,(Month 3)
Percent change in non-inflammatory acne lesions(Month 3)
Percentage of subjects with a ≥2 point score improvement on the Investigators Global Assessment (IGA) scale(Month 3)