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CompletedNCT07739212Updated Jul 31, 2026

Treatment of Aging Signs of the Skin With Bipolar Radiofrequency

An observational study in Wrinkles and Rhytides, sponsored by Alma Mater Europaea College of Medical Sciences "Rezonanca". Completed at 1 site in Kosovo. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by Alma Mater Europaea College of Medical Sciences "Rezonanca" · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study summary

This is a retrospective data collection from patients treated with the bipolar radiofrequency applicator (Coaxipolar) of the Accent devices. Patient files were screened for suitable candidates providing before and after treatment pictures for blinded evaluation. The safety and efficacy of bipolar RF technology, both as a standalone treatment and in combination with unipolar RF, for facial contouring and the reduction of wrinkles and fine lines is investigated.

02

Conditions studied

  • Wrinkles and Rhytides

Keywords

  • wrinkles, skin laxity,
03

In context

Lead sponsor

This is the only study on the registry with Alma Mater Europaea College of Medical Sciences "Rezonanca" as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

A total of up to 150 adult subjects of both genders and all skin types are to be included if they meet all of the inclusion and none of the exclusion criteria. Investigator is collecting data retrospectively from their respective patient pool.

Eligibility criteria

Inclusion Criteria:

  • Healthy male or female ≥18 years old.
  • Complete Medical History records are available
  • Documented baseline and follow-up digital images are available
  • Treatment with one applicator only for the approved indication for bipolar applicator such as skin laxity, wrinkles and rhytids
  • provided consent for before and after (B\&A) pictures for evaluation Fitzpatrick skin type I- VI

Exclusion Criteria:

  • Exclusions per the Operational Manual
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
150 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. GAIS

    Skin laxity was assessed using the Global Aesthetic Improvement Scale (GAIS; 0-4 scale), GAIS 5-point scale (0 = worse, 1 = no change, 2 = mild improvement, 3 = much improvement, 4 = very much improvement)

    Time frame: From enrollment to the end of treatment at 24 weeks

Secondary outcomes

  1. Fitzpatrick-wrinkle-scale

    Wrinkle severity was assessed by the same three blinded evaluators using the MFWS with seven graded classes ranging from Class 0 (no wrinkles) to Class 3 (deep wrinkles) based on estimated wrinkle depth

    Time frame: From enrollment to the end of treatment at 24 weeks

  2. VISIA Score Change (if applicable)

    The VISIA® Complexion Analysis Camera (Canfield Scientific, USA) captures standardized images to quantify wrinkle features using absolute scores, which measure the size, area, and intensity of skin features. Changes from baseline are calculated as the average of bilateral measurements, where negative change scores indicate clinical improvement.

    Time frame: From enrollment to the end of treatment at 24 weeks

  3. Patient satisfaction (if applicable)

    Self-reported on a 5-point Likert scale (0 = worse, 1 = no change, 2 = satisfied, 3 = much satisfied, 4 = very much satisfied)

    Time frame: From enrollment to the end of treatment at 24 weeks

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Study locations

1 site
  • Estethica Clinic
    Pristina, 10000, Kosovo
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07739212
Lead sponsor
Alma Mater Europaea College of Medical Sciences "Rezonanca"
Responsible party
Sponsor
First posted
Jul 31, 2026
Start date
Jul 5, 2025
Primary completion
Aug 30, 2025
Completion
Dec 30, 2025
Last update
Jul 31, 2026

Oversight

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

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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