ClinicalTrials.gg
Active, not recruitingNCT06315166Updated Feb 19, 2026

Study on Using Radiofrequency to Treat Moderate to Severe Acne

An interventional study of triLift/Legend Pro+ Fractional RF System in Moderate to Severe Acne Vulgaris, sponsored by Pollogen. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-02-19.

Sponsored by Pollogen (part of Lumenis Be Ltd.) · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 25 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 373 studies in Acne Vulgaris with a site in United States — 20 open to participants now, 29 under way, 2 of them phase 3. Acne Vulgaris · United States.

Planned enrollment
261st of 353
30 · median 78
Started
2024
with 13 others
No phase
77 of 373
9 open now
Primary completion
2026-12
later than 15 of 28 live
Registered
343rd of 373
by date

Among the 373 studies in Acne Vulgaris with a site in United States, this one is the 261st largest by planned enrollment of the 353 interventional ones that give a count, is one of 14 that started in 2024, is one of 77 with no phase, reaches primary completion later than 15 of the 28 other live ones, and was the 343rd registered.

Acne Vulgaris

791 studies on the registry are indexed under Acne Vulgaris; 94 are open to participants now.

Browse Acne Vulgaris studies →

Open to participants now

20 of the 373 studies in Acne Vulgaris with a site in United States are open now. Recruiting first, the newest first:

15 more — sign in →

All 20 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 47 Acne Vulgaris studies recruiting now, 17 (36%) set no upper age limit and 29 (62%) stop at 75 or younger; 21 take children under 18; 17 take healthy volunteers.

This study: 18 Years to 25 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 373 studies in Acne Vulgaris with a site in United States, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Moderate to Severe Acne Vulgaris

Browse trials for

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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.
  2. 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.
  3. 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 study.
  4. 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.
  5. Participant understood and voluntarily provided written .
  6. Participant is able and willing to comply with the treatment/follow-up schedule and requirements of the investigation protocol.
  7. Female of child-bearing age who agreed to use a reliable method of 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.

Exclusion criteria

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from participation in the clinical investigation:

  1. Pregnant or lactating woman, or with a high probability of becoming pregnant during the investigation period.
  2. Current or history of any kind of cancer, or dysplastic nevi.
  3. Current of history of severe concurrent conditions, such as cardiac disorders or poorly controlled endocrine disorders, such as diabetes.
  4. History of coagulopathies or current use of anticoagulants (excluding daily aspirin).
  5. Known impaired immune system due to diseases, such as AIDS and , or use of immunosuppressive medications.
  6. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.
  7. History of abnormal wound healing leading to hypertrophic or keloid scarring
  8. History of energy-based acne treatment within 6 months prior to the investigation treatment or as per investigators discretion.
  9. History of facial dermabrasion, facial resurfacing, or deep chemical peeling within 3 months prior to the investigation treatment.
  10. History of any surgical procedure in the treatment area within 6 months prior to the investigation treatment or before complete healing.
  11. 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.
  12. History of systemic or oral antibiotic consumption, except for tetracycline antibiotics class of drug, within 3 months prior to the investigation treatment.
  13. History of intralesional injections, incision and drainage, or surgical excision within 1 month prior to the investigation treatment.
  14. Presence of any implantable metal device in the treatment area.
  15. Presence of pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g., cochlear implant).
  16. Presence of any active skin condition in the treatment area, such as sores, psoriasis, eczema, and rash.
  17. Presence of tattoo or permanent makeup in designated treatment area.
  18. 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    Single Arm

    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.

    Device: triLift/Legend Pro+ Fractional RF System

Interventions

  • DevicetriLift/Legend Pro+ Fractional RF System

    The triLift/Legend Pro+ Fractional investigational device is intended for the treatment of acne vulgaris when using Fractional RF energy.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 3 and 6 months post last treatment visit.

Secondary outcomes

  1. 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.

    Time frame: 3, 6, and optional 9 months post last treatment visit.

  2. 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.

    Time frame: 3, 6, and optional 9 months post last treatment visit.

07

Study locations

1 site
  • Cosmedic Dermatology (CosmedicDerm)
    Grosse Pointe, Michigan 48230, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2024 (actual). Primary completion is estimated for Dec 2026, 31 months after the start.

Of 62 industry-sponsored interventional studies with no phase under Acne Vulgaris, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 19. This study's planned 31 months is above that.

Counting every sponsor, half of 120 studies reached it within 9 months; a quarter within 4 and three quarters within 18.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 11, 2024
First posted
Mar 18, 2024
StartActual
May 23, 2024
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2027
Last update
Feb 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06315166
Lead sponsor
Pollogen
Collaborators
Lumenis Be Ltd.
Responsible party
Sponsor
First posted
Mar 18, 2024
Start date
May 23, 2024
Primary completion
Dec 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Feb 19, 2026

Study contacts

Yuri Vinshtok
study director · Pollogen Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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