Clinical trial NCT05830968: Safety and Efficacy of Radio Frequency for the Treatment of Mild to Severe Inflammatory Acne
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Acne Vulgaris
Lead sponsor: InMode MD Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-26
Enrollment: 42
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Study Design Prospective, multicenter clinical study
Primary purpose: TREATMENT

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: 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

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.
* Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area
* Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction.
* Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
* History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
* History of bleeding coagulopathies or use of anticoagulants in the last 10 days.
* Any surgery in treated area within 3 months prior to treatment.
* Subject received other treatments such as light, CO2 laser or RF in the treatment area within 6 months of study start date.
* Simultaneous participation in another investigator drug or device study or completion of the follow-up phase for the primary endpoint of any previous study less than 30 days prior to the first evaluation in this study.
* Subject that has any condition that, at the investigator's discretion, renders the subject unsuitable for participation in this clinical research study.

Primary outcomes:
measure: Percent of responder
timeFrame: Month 3
Secondary outcomes:
measure: Absolute change in number of inflammatory acne lesions
timeFrame: Month 3
measure: Percentage of subjects with a ≥2 point score improvement on the Investigators Global Assessment (IGA) scale
timeFrame: Month 3
measure: Absolute change in non-inflammatory acne lesions
timeFrame: Month 3
measure: The rate of patient satisfaction with treatment,
timeFrame: Month 3
measure: percent change in non-inflammatory acne lesions
timeFrame: Month 3
measure: Percent change in non-inflammatory acne lesions
timeFrame: Month 3
Other outcomes:
Locations:
city: Oro Valley
country: United States
facility: Avant Dermatology Aesthetics
state: Arizona
city: Greenwood Village
country: United States
facility: AboutSkin Research, LLC
state: Colorado
city: New York
country: United States
facility: UnionDerm
state: New York
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
name: Anna M Chapas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unafilliated
name: Jole L Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: