Treatment of Aging Signs of the Skin With Bipolar Radiofrequency

NCT07739212 | Completed

• 1 other identifier: AD-2687/25
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Wrinkles and Rhytides

Keywords

wrinkles, skin laxity,

Outcome Measures

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)

  From enrollment to the end of treatment at 24 weeks

Secondary Outcomes (3)

• Fitzpatrick-wrinkle-scale

  From enrollment to the end of treatment at 24 weeks

• VISIA Score Change (if applicable)

  From enrollment to the end of treatment at 24 weeks

• Patient satisfaction (if applicable)

  From enrollment to the end of treatment at 24 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Alma Mater Europaea College of Medical Sciences "Rezonanca": lead

Study Sites (1)

Estethica Clinic

Pristina, 10000, Kosovo

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 31, 2026
• Study Start: July 5, 2025
• Primary Completion: August 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 31, 2026

Record last verified: 2025-07

Locations

KO (1)