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NCT05254210

Feasibility Study To Collect Safety And Preliminary Efficacy Data For A Radiofrequency Microneedling Device

Completed NA Results posted Last updated 15 August 2023
What this trial tests

NA trial testing RF Device (Potenza™) in Wrinkles in 10 participants. Completed in 17 May 2022.

Timeline
13 September 2021
Primary endpoint
17 May 2022
17 May 2022

Quick facts

Lead sponsorCynosure, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment10
Start date13 September 2021
Primary completion17 May 2022
Estimated completion17 May 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Cynosure, Inc. — full company profile →

Who can join

Adults 18 to 60, any sex, with Wrinkles or Fine Lines. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Evaluation of Baseline Photographs Compared to Post Treatment Images Primary · 30 day follow up

Photographs will be evaluated at the baseline and the 30 day follow up. The number of photographs with improvement (based on changes in the skin) from baseline to follow up images will be reported.

GroupValue95% CI
Treatment With RF Device8

Sponsor's own description

The intended use of the Potenza™ device is to collect clinical data for brow lifting and/or treatment of dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Wrinkles

Currently open trials in the same condition.

Other Cynosure, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05254210.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing