Wrinkles and RhytidesNCT07739212
Treatment of Aging Signs of the Skin With Bipolar Radiofrequency
An observational study of Wrinkles and Rhytides, run by Alma Mater Europaea College of Medical Sciences "Rezonanca" at 1 site in Kosovo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wrinkles and Rhytides
- How many people
- 150 participants
- Where
- 1 siteKosovo
- Study dates
- 5 Jul 2025to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Exclusions per the Operational Manual
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Data Collection to Evaluate the Safety and Performance of Accent System / BiPolarRF for the Treatment of Approved Indications Data Collection Protocol
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,
- Medical subject headings
- Cutis Laxa
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From enrollment to the end of treatment at 24 weeks
Secondary outcomes (3)
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
Measured: From enrollment to the end of treatment at 24 weeks
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.
Measured: From enrollment to the end of treatment at 24 weeks
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)
Measured: From enrollment to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start5 Jul 2025
- Primary completion30 Aug 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrinkles and RhytidesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alma Mater Europaea College of Medical Sciences "Rezonanca"
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739212
- Sponsor's protocol ID
- AD-2687/25
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Data Collection to Evaluate the Safety and Performance of Accent System / BiPolarRF for the Treatment of Approved Indications Data Collection Protocol
- ClinicalTrials.gov ID
- NCT07739212
- Acronym / sponsor ID
- AD-2687/25
- Conditions
- Wrinkles and Rhytides
- Keywords
- wrinkles, skin laxity,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Alma Mater Europaea College of Medical Sciences "Rezonanca"University, hospital or other
- Study start
- 5 Jul 2025 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Exclusions per the Operational Manual
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
3 secondary outcomes
Fitzpatrick-wrinkle-scale
Time frame: From enrollment to the end of treatment at 24 weeks
VISIA Score Change (if applicable)
Time frame: From enrollment to the end of treatment at 24 weeks
Patient satisfaction (if applicable)
Time frame: From enrollment to the end of treatment at 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wrinkles and Rhytides, run by Alma Mater Europaea College of Medical Sciences "Rezonanca" at 1 site in Kosovo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kosovo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GAIS (time frame: From enrollment to the end of treatment at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.