Recruiting

Radio Frequency

Sponsor:

InMode MD Ltd.

Code:

NCT05830968

Conditions

Inflammatory Acne Vulgaris

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

Interventions

Morpheus8 Applicator Radiofrequency device

Study Details

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

Conditions

Inflammatory Acne Vulgaris

Study ID

NCT05830968

Start date

May 1, 2023

Status verified date

Feb, 2024

Completion date

May 1, 2026

Anticipated

Primary completion date

May 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

42 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Device treatment

Treatment area will include affected areas over the entire face (presence of comedones, pustules, papules, nodules and cysts

Interventions

Morpheus8 Applicator Radiofrequency device

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.

Primary outcome measure

  • Percent of responder [ Time Frame: Month 3 ]

Central Contacts and Locations

Central contacts

Locations

Avant Dermatology Aesthetics

Recruiting

Oro Valley, Arizona, United States, 85704

Contacts

Principal Investigator:

Sheila Farhang, MD

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Jennifer Barrilas

214-645-2353

More Information

Sponsor

InMode MD Ltd.

Last update posted

May 29, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by InMode MD Ltd. on 2024-05-29.