Study on Using Radiofrequency to Treat Moderate to Severe Acne

NCT06315166 | Active Not Recruiting FDA Device

• 1 other identifier: CIP-PLG_CLINICAL-22-04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the safety and efficacy of fractional radiofrequency for the treatment of moderate to severe acne vulgaris.

Conditions

Moderate to Severe Acne Vulgaris

Outcome Measures

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).

  3 and 6 months post last treatment visit.

Secondary Outcomes (2)

• Overall Improvement of Acne

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

• Subjective Satisfaction with the Treatment Results

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

Study Arms (1)

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.

Device: triLift/Legend Pro+ Fractional RF System

Interventions

triLift/Legend Pro+ Fractional RF System DEVICE

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

Single Arm

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Pollogen: lead
• Lumenis Be Ltd.: collaborator

Study Sites (1)

Cosmedic Dermatology (CosmedicDerm)

Grosse Pointe, Michigan, 48230, United States

Location

Study Officials

• Yuri Vinshtok

  Pollogen Ltd.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: May 23, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)