Moderate to Severe Acne VulgarisNCT06315166
Study on Using Radiofrequency to Treat Moderate to Severe Acne
A study testing triLift/Legend Pro+ Fractional RF System in people with Moderate to Severe Acne Vulgaris, run by Pollogen at 1 site in United States.
Trial summary
Evaluation of the safety and efficacy of fractional radiofrequency for the treatment of moderate to severe acne vulgaris. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Moderate to Severe Acne Vulgaris
- What is being tested?
- triLift/Legend Pro+ Fractional RF System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female participant of 18 - 25 years of age, who are diagnosed with moderate to severe facial acne vulgaris and who seek treatment of their acne lesions.
- Moderate is defined as a participant with an Acne Grading Scoring System (AGSS) of 4 with 20 to 40 inflammatory lesions (papules and pustules) and no more than 1 nodule. Severe is defined as a participant with an AGSS of 5 with a greater than 40 inflammatory lesions with the presence of no more than 2 nodules and/or inflammatory scaring type lesion.
- Participant has a similar disease stage on both sides of their face with at least 15 inflammatory acne lesions (papules, pustules, or nodules) on each buccal areas of the face.
- Participant is already taking prescribed tetracycline class of antibiotics (i.e., Doxycycline-oral route) for the treatment of moderate to severe acne vulgaris or will begin taking prescribed tetracycline class of antibiotics for the treatment of moderate to severe acne vulgaris and agree to continue the medication for the applicable duration as required by the investigational study.
- Participant is abstinent from topical anti-acne medication for 1 month and oral anti-acne medication for 6 months (except for tetracycline antibiotics class of drug) prior to the investigation treatment and for the applicable duration as required by the investigational study.
- Participant understood and voluntarily provided written Informed Consent.
- Participant is able and willing to comply with the treatment/follow-up schedule and requirements of the investigation protocol.
- Female of child-bearing age who agreed to use a reliable method of birth control at least 3 months prior to investigation enrollment and for the whole duration of the investigation and have a negative Urine Pregnancy test at screening visit.
Who cannot join
- Participants who meet any of the following criteria will be excluded from participation in the clinical investigation:
- Pregnant or lactating woman, or with a high probability of becoming pregnant during the investigation period.
- Current or history of any kind of cancer, or dysplastic nevi.
- Current of history of severe concurrent conditions, such as cardiac disorders or poorly controlled endocrine disorders, such as diabetes.
- History of coagulopathies or current use of anticoagulants (excluding daily aspirin).
- Known impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
Show all 19Show fewer
- History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.
- History of abnormal wound healing leading to hypertrophic or keloid scarring
- History of energy-based acne treatment within 6 months prior to the investigation treatment or as per investigators discretion.
- History of facial dermabrasion, facial resurfacing, or deep chemical peeling within 3 months prior to the investigation treatment.
- History of any surgical procedure in the treatment area within 6 months prior to the investigation treatment or before complete healing.
- History of taken any medication known to affect sebum secretion such isotretinoin (Accutane®) or other systemic retinoids use within 6 months prior to the investigation treatment or as per investigators discretion.
- History of systemic or oral antibiotic consumption, except for tetracycline antibiotics class of drug, within 3 months prior to the investigation treatment.
- History of intralesional corticosteroid injections, incision and drainage, or surgical excision within 1 month prior to the investigation treatment.
- Presence of any implantable metal device in the treatment area.
- Presence of pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g., cochlear implant).
- Presence of any active skin condition in the treatment area, such as sores, psoriasis, eczema, and rash.
- Presence of tattoo or permanent makeup in designated treatment area.
- Presence of excessively tanned skin or use of tanning beds or tanning creams in the designated treatment area within 2 weeks prior to the investigation treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cosmedic Dermatology (CosmedicDerm)
Grosse Pointe, Michigan, 48230
About this study
Official title: Clinical Evaluation of Fractional Radiofrequency for the Treatment of Moderate to Severe Acne Vulgaris
Evaluation of the safety and efficacy of fractional radiofrequency for the treatment of moderate to severe acne vulgaris.
Read the detailed description
This is an interventional, multicenter, open (self-controlled) trial to evaluate the safety and efficacy of fractional radiofrequency for the treatment of moderate to severe acne vulgaris. The study will evaluate up to 30 male or female participants requesting treatment for the reduction of moderate to severe acne vulgaris. The study will involve three treatments of fractional radiofrequency. Treatments will be randomized with combination antibiotic/ fractional radiofrequency therapy. The subject will act as their own control, where one side of the face (buccal area) will be treated, and the other will not be and will act as the control.
- Conditions
- Moderate to Severe Acne Vulgaris
- Being tested
- triLift/Legend Pro+ Fractional RF System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triLift/Legend Pro+ Fractional RF SystemDevice
The triLift/Legend Pro+ Fractional investigational device is intended for the treatment of acne vulgaris when using Fractional RF energy.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Open(self-controlled) split-face design study. Thirty participants will undergo the treatments on one side of the face (buccal area). Treatments will be randomized with combination antibiotic/ FRF therapy. Receives: Device: triLift/Legend Pro+ Fractional RF System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Efficacy of Fractional RF for the Treatment of Moderate to Severe Acne Vulgaris
Improvement in acne vulgaris compared to baseline utilizing the Acne Grading Scoring System (AGSS).
Measured: 3 and 6 months post last treatment visit.
Secondary outcomes (2)
Overall Improvement of Acne
Improvement of acne based on the participant's assessment of acne using the 1-7 Patient Global Impression of Change (PGIC) scale. Higher scores mean a better outcome.
Measured: 3, 6, and optional 9 months post last treatment visit.
Subjective Satisfaction with the Treatment Results
Subjective satisfaction with the treatment results as assessed using the 0-4 Participant Satisfaction Scale. Higher scores mean a better outcome.
Measured: 3, 6, and optional 9 months post last treatment visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start23 May 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pollogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lumenis Be Ltd.
- Responsible party
- Sponsor
- Investigators
- Yuri Vinshtok, Study director, Pollogen Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315166
- Sponsor's protocol ID
- CIP-PLG_CLINICAL-22-04
- Status last verified
- Feb 2026
- First submitted
- 11 Mar 2024
- Last updated
- 19 Feb 2026
- 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 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Fractional Radiofrequency for the Treatment of Moderate to Severe Acne Vulgaris
- ClinicalTrials.gov ID
- NCT06315166
- Acronym / sponsor ID
- CIP-PLG_CLINICAL-22-04
- Conditions
- Moderate to Severe Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- PollogenIndustry (pharma, biotech, devices)
- Collaborators
- Lumenis Be Ltd.
- Study start
- 23 May 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Mar 2024 (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.
Evaluation of the safety and efficacy of fractional radiofrequency for the treatment of moderate to severe acne vulgaris.
Detailed description
This is an interventional, multicenter, open (self-controlled) trial to evaluate the safety and efficacy of fractional radiofrequency for the treatment of moderate to severe acne vulgaris. The study will evaluate up to 30 male or female participants requesting treatment for the reduction of moderate to severe acne vulgaris. The study will involve three treatments of fractional radiofrequency. Treatments will be randomized with combination antibiotic/ fractional radiofrequency therapy. The subject will act as their own control, where one side of the face (buccal area) will be treated, and the other will not be and will act as the control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Device: triLift/Legend Pro+ Fractional RF SystemOpen(self-controlled) split-face design study. Thirty participants will undergo the treatments on one side of the face (buccal area). Treatments will be randomized with combination antibiotic/ FRF therapy. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female participant of 18 - 25 years of age, who are diagnosed with moderate to severe facial acne vulgaris and who seek treatment of their acne lesions.
- Participant has a similar disease stage on both sides of their face with at least 15 inflammatory acne lesions (papules, pustules, or nodules) on each buccal areas of the face.
- Participant is already taking prescribed tetracycline class of antibiotics (i.e., Doxycycline-oral route) for the treatment of moderate to severe acne vulgaris or will begin taking prescribed tetracycline class of antibiotics for the treatment of moderate to severe acne vulgaris and agree to continue the medication for the applicable duration as required by the investigational study.
- Participant is abstinent from topical anti-acne medication for 1 month and oral anti-acne medication for 6 months (except for tetracycline antibiotics class of drug) prior to the investigation treatment and for the applicable duration as required by the investigational study.
- Participant understood and voluntarily provided written Informed Consent.
Key exclusion criteria (19 listed)
- Participants who meet any of the following criteria will be excluded from participation in the clinical investigation:
- Pregnant or lactating woman, or with a high probability of becoming pregnant during the investigation period.
- Current or history of any kind of cancer, or dysplastic nevi.
- Current of history of severe concurrent conditions, such as cardiac disorders or poorly controlled endocrine disorders, such as diabetes.
- History of coagulopathies or current use of anticoagulants (excluding daily aspirin).
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 |
|---|---|---|
| triLift/Legend Pro+ Fractional RF SystemThe triLift/Legend Pro+ Fractional investigational device is intended for the treatment of acne vulgaris when using Fractional RF energy. | Device | Single Arm |
Primary outcome
Evaluate the Efficacy of Fractional RF for the Treatment of Moderate to Severe Acne Vulgaris
Time frame: 3 and 6 months post last treatment visit.
Improvement in acne vulgaris compared to baseline utilizing the Acne Grading Scoring System (AGSS).
2 secondary outcomes
Overall Improvement of Acne
Time frame: 3, 6, and optional 9 months post last treatment visit.
Subjective Satisfaction with the Treatment Results
Time frame: 3, 6, and optional 9 months post last treatment visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- 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.
Yuri Vinshtok study director
Pollogen Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing triLift/Legend Pro+ Fractional RF System in people with Moderate to Severe Acne Vulgaris, run by Pollogen at 1 site 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 8 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the Efficacy of Fractional RF for the Treatment of Moderate to Severe Acne Vulgaris (time frame: 3 and 6 months post last treatment visit.). 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 19 Feb 2026.