At a glance
ClinicalIndex Comparison RecordN/ACompleted· 15 enrolled
Drug / intervention
Dermal Handpiecedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling
University of Texas Southwestern Medical Center·interventional·Posted Jul 20, 2020·Updated Dec 19, 2023
In Brief
A clinical study evaluating Dermal Handpiece for Skin Laxity. Completed, enrolled 15 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of bipolar fractional radiofrequency treatment via use of the Profound System to achieve skin tightening and contour change in lax submental (beneath the chin) tissue.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSkin Laxity
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
202120222023202420252026
First PostedJul 2020
Enrollment StartOct 2020
Primary CompletionJun 2022
Study CompletionDec 2022
TodayJul 2026
First PostedJul 20, 2020
Enrollment StartOct 1, 2020
Primary CompletionJun 13, 2022
Study CompletionDec 22, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.0 years ago
Interventions
Dermal Handpiecedevice
Radiofrequency (RF) will travel through the RF generator through the electrodes and into the dermal layer beneath the surface of the skin. The microneedles of the dermal cartridges coupled with the thermal heat will stimulate neocollagenesis and neoelastosis, aiding in the reduction of submental laxity.