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OpenTrials
Completed

NCT Number: NCT07739212

Treatment of Aging Signs of the Skin With Bipolar Radiofrequency

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.

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Key information

Conditions

Wrinkles and Rhytides Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutis Laxa Genetic Diseases, Inborn Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Estethica Clinic

Pristina, 10000, Kosovo

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. GAIS

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

    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)

Secondary outcomes

  1. Fitzpatrick-wrinkle-scale

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

    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

  2. VISIA Score Change (if applicable)

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

    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.

  3. Patient satisfaction (if applicable)

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

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

Sponsors and collaborators

Lead sponsor

Alma Mater Europaea College of Medical Sciences "Rezonanca"

Other

Registry information

Official study title

Retrospective Data Collection to Evaluate the Safety and Performance of Accent System / BiPolarRF for the Treatment of Approved Indications Data Collection Protocol

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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