RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

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

Quick Facts

Study Start:2023-05-01

Study Completion:2026-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05830968

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Meital Matalon, MS

CONTACT

9492588870

meital.matalon@inmodemd.com

Maria Shusterman, RN

CONTACT

9492396522

maria.shusterman@inmodemd.com

Principal Investigator

Anna M Chapas, MD

PRINCIPAL_INVESTIGATOR

Jole L Cohen, MD

PRINCIPAL_INVESTIGATOR

Unafilliated

Study Locations (Sites)

Avant Dermatology Aesthetics

Oro Valley, Arizona, 85704

United States

AboutSkin Research, LLC

Greenwood Village, Colorado, 80111

United States

UnionDerm

New York, New York, 10003

United States

UT Southwestern Medical Center

Dallas, Texas, 75390

United States

Collaborators and Investigators

Sponsor: InMode MD Ltd.

Anna M Chapas, MD, PRINCIPAL_INVESTIGATOR
Jole L Cohen, MD, PRINCIPAL_INVESTIGATOR, Unafilliated

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-01

Study Completion Date2026-05-01

Study Record Updates

Study Start Date2023-05-01

Study Completion Date2026-05-01

Terms related to this study

Additional Relevant MeSH Terms

Inflammatory Acne Vulgaris