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

Primary Purpose

Inflammatory Acne Vulgaris

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Morpheus8 Applicator Radiofrequency device
Sponsored by
InMode MD Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Acne Vulgaris

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Avant Dermatology AestheticsRecruiting
  • AboutSkin Research, LLCRecruiting
  • UnionDermRecruiting
  • UT Southwestern Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Absolute change in number of inflammatory acne lesions
Absolute change in number of inflammatory acne lesions from baseline to 12 weeks after the last treatment, as assessed by 3 independent reviewers using clinical photographs
Percentage of subjects with a ≥2 point score improvement on the Investigators Global Assessment (IGA) scale
Percentage of subjects with a ≥2 point score improvement on the Investigators Global Assessment (IGA) scale at 12 weeks after the last treatment compared to baseline as assessed by three independent reviewers using clinical photographs.
Absolute change in non-inflammatory acne lesions
Absolute change In non-inflammatory acne lesions from baseline to 12 weeks after the last treatment, as assessed by 3 independent reviewers from clinical photographs
The rate of patient satisfaction with treatment,
The rate of patient satisfaction with treatment, using a 5-point Likert scale at 12 weeks after the last treatment
percent change in non-inflammatory acne lesions
percent change in number of inflammatory acne lesions from baseline to 12 weeks after the last treatment, as assessed by 3 independent reviewers using clinical photographs
Percent change in non-inflammatory acne lesions
Percent change in non-inflammatory acne lesions from baseline to 12 weeks after the last treatment, as assessed by 3 independent reviewers from clinical photographs

Full Information

First Posted
April 13, 2023
Last Updated
October 19, 2023
Sponsor
InMode MD Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05830968
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InMode MD Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Study Design Prospective, multicenter clinical study
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Device treatment
Arm Type
Experimental
Arm Description
Treatment area will include affected areas over the entire face (presence of comedones, pustules, papules, nodules and cysts
Intervention Type
Device
Intervention Name(s)
Morpheus8 Applicator Radiofrequency device
Intervention Description
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 Information:
Title
Percent of responder
Description
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.
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Absolute change in number of inflammatory acne lesions
Description
Absolute change in number of inflammatory acne lesions from baseline to 12 weeks after the last treatment, as assessed by 3 independent reviewers using clinical photographs
Time Frame
Month 3
Title
Percentage of subjects with a ≥2 point score improvement on the Investigators Global Assessment (IGA) scale
Description
Percentage of subjects with a ≥2 point score improvement on the Investigators Global Assessment (IGA) scale at 12 weeks after the last treatment compared to baseline as assessed by three independent reviewers using clinical photographs.
Time Frame
Month 3
Title
Absolute change in non-inflammatory acne lesions
Description
Absolute change In non-inflammatory acne lesions from baseline to 12 weeks after the last treatment, as assessed by 3 independent reviewers from clinical photographs
Time Frame
Month 3
Title
The rate of patient satisfaction with treatment,
Description
The rate of patient satisfaction with treatment, using a 5-point Likert scale at 12 weeks after the last treatment
Time Frame
Month 3
Title
percent change in non-inflammatory acne lesions
Description
percent change in number of inflammatory acne lesions from baseline to 12 weeks after the last treatment, as assessed by 3 independent reviewers using clinical photographs
Time Frame
Month 3
Title
Percent change in non-inflammatory acne lesions
Description
Percent change in non-inflammatory acne lesions from baseline to 12 weeks after the last treatment, as assessed by 3 independent reviewers from clinical photographs
Time Frame
Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meital Matalon, MS
Phone
9492588870
Ext
324
Email
meital.matalon@inmodemd.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Shusterman, RN
Phone
9492396522
Ext
317
Email
maria.shusterman@inmodemd.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna M Chapas, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jole L Cohen, MD
Organizational Affiliation
Unafilliated
Official's Role
Principal Investigator
Facility Information:
Facility Name
Avant Dermatology Aesthetics
City
Oro Valley
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irene Stefanoto
Phone
520-353-4195
Email
admin@avantdermatology.com
First Name & Middle Initial & Last Name & Degree
Sheila Farhang, MD
Facility Name
AboutSkin Research, LLC
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Dahler
Phone
303-756-7546
Ext
114
Email
ddahler@aboutskinderm.com
Facility Name
UnionDerm
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellie Smeallie, MD
Phone
212-366-5400
Email
research@unionderm.com
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Barrilas
Phone
214-645-2353

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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