Treatment of Aging Signs of the Skin With Bipolar Radiofrequency

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07739212

Enrollment

150

Registered

2026-07-31

Start date

2025-07-05

Completion date

2025-12-30

Last updated

2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wrinkles and Rhytides

Keywords

wrinkles, skin laxity,

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
GAIS	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

Measure	Time frame	Description
Fitzpatrick-wrinkle-scale	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
VISIA Score Change (if applicable)	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.
Patient satisfaction (if applicable)	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)

Countries

Kosovo

Outcome results