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

NCT05830968 | Recruiting FDA Device

• 1 other identifier: DO611175A
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Percent of responder

  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.

  Month 3

Secondary Outcomes (6)

• Absolute change in number of inflammatory acne lesions

  Month 3

• Percentage of subjects with a ≥2 point score improvement on the Investigators Global Assessment (IGA) scale

  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

Study Arms (1)

Device treatment

EXPERIMENTAL

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

Device: Morpheus8 Applicator Radiofrequency device

Interventions

Morpheus8 Applicator Radiofrequency device 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.

Device treatment

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• InMode MD Ltd.: lead

Study Sites (4)

Avant Dermatology Aesthetics

Oro Valley, Arizona, 85704, United States

RECRUITING

AboutSkin Research, LLC

Greenwood Village, Colorado, 80111, United States

ACTIVE NOT RECRUITING

UnionDerm

New York, New York, 10003, United States

ACTIVE NOT RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Study Officials

• Anna M Chapas, MD

  PRINCIPAL INVESTIGATOR

• Jole L Cohen, MD

  Unafilliated

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meital Matalon, MS

CONTACT

9492588870; meital.matalon@inmodemd.com

Maria Shusterman, RN

CONTACT

9492396522; maria.shusterman@inmodemd.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study Design Prospective, multicenter clinical study

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: April 26, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: May 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)