Inflammatory Acne VulgarisNCT05830968
Safety and Efficacy of Radio Frequency for the Treatment of Mild to Severe Inflammatory Acne
A study testing Morpheus8 Applicator Radiofrequency device in people with Inflammatory Acne Vulgaris, run by InMode MD Ltd. at 4 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Acne Vulgaris
- What is being tested?
- Morpheus8 Applicator Radiofrequency device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 May 2023to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 26Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 2 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Jennifer Barrilas, 214-645-2353
- Active, not recruiting
AboutSkin Research, LLC
Greenwood Village, Colorado, 80111
- Active, not recruiting
UnionDerm
New York, New York, 10003
- Recruiting
Avant Dermatology Aesthetics
Oro Valley, Arizona, 85704
Irene Stefanoto, 520-353-4195, admin@avantdermatology.com
Sheila Farhang, MD
About this study
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
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
Read the 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
- Conditions
- Inflammatory Acne Vulgaris
- Being tested
- Morpheus8 Applicator Radiofrequency device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morpheus8 Applicator Radiofrequency deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Device treatment | Experimental | Treatment area will include affected areas over the entire face (presence of comedones, pustules, papules, nodules and cysts Receives: Device: Morpheus8 Applicator Radiofrequency device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 3
Secondary outcomes (6)
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
Measured: Month 3
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.
Measured: Month 3
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
Measured: Month 3
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
Measured: Month 3
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
Measured: Month 3
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
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start1 May 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study Design Prospective, multicenter clinical study
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InMode MD Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna M Chapas, MD, Principal investigatorJole L Cohen, MD, Principal investigator, Unafilliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830968
- Sponsor's protocol ID
- DO611175A
- Status last verified
- Feb 2024
- First submitted
- 13 Apr 2023
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05830968
- Acronym / sponsor ID
- DO611175A
- Conditions
- Inflammatory Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- InMode MD Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study Design Prospective, multicenter clinical study
| Arm | Type | Receives |
|---|---|---|
| Device treatment | Experimental | Device: Morpheus8 Applicator Radiofrequency deviceTreatment area will include affected areas over the entire face (presence of comedones, pustules, papules, nodules and cysts |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (26 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morpheus8 Applicator Radiofrequency deviceEligible 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 | Device treatment |
Primary outcome
Percent of responder
Time frame: Month 3
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.
6 secondary outcomes
Absolute change in number of inflammatory acne lesions
Time frame: Month 3
Percentage of subjects with a ≥2 point score improvement on the Investigators Global Assessment (IGA) scale
Time frame: Month 3
Absolute change in non-inflammatory acne lesions
Time frame: Month 3
The rate of patient satisfaction with treatment,
Time frame: Month 3
percent change in non-inflammatory acne lesions
Time frame: Month 3
Percent change in non-inflammatory acne lesions
Time frame: Month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna M Chapas, MD principal investigator
Jole L Cohen, MD principal investigator
Unafilliated
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morpheus8 Applicator Radiofrequency device in people with Inflammatory Acne Vulgaris, run by InMode MD Ltd. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meital Matalon, MS (9492588870 ext. 324, meital.matalon@inmodemd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of responder (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.