NCT05517824CompletedNot Applicable
Efficacy and Safety of the Micro-insulated Needle Radiofrequency Device for Reduction of Submental Fat
Seoul National University Bundang Hospital1 site in 1 country24 target enrollmentStarted: June 7, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Physician-Assisted Submental Fat Rating Scale score from 0 (nothing) to 4 (very severe)
Study Overview
Brief Summary
The investigators aimed to evaluate the efficacy and safety of a fractional radiofrequency device with a micro-insulated needle to reduce submental fat.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients with excess submental fat on a grade of 1~4, as assessed by the Physician-Assisted Submental Fat Rating Scale
Exclusion Criteria
- •mental impairment, infectious disease
- •history of keloid development
- •pregnancy, pacemaker
- •use of anticoagulants
- •undergoing a facelift procedure within the prior 6 months.
Arms & Interventions
Post-treatment
Active Comparator
After a single treatment using a microinsulated needle RF device
Intervention: microinsulated needle radiofrequency (Procedure)
Pre-treatment (Baseline)
No Intervention
Outcomes
Primary Outcomes
Physician-Assisted Submental Fat Rating Scale score from 0 (nothing) to 4 (very severe)
Time Frame: 1 month after the treatment
submental fat rating by an independent investigator
Secondary Outcomes
- submental fat volume (cc)(1 month after the treatment)
- patient satisfaction score from 0 (not satisfied) to 10 (most satisfied)(1 month after the treatment)
- any adverse effects at any time during or after treatment(assessed through study completion, an average of 2 months)
Investigators
Jung-Won Shin
Associate Professor
Seoul National University Bundang Hospital
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Phase 4
The efficacy of insulated microneedle radiofrequency in Keratosis pilarisKeratosis pilaris patients in Srinakharinwirot university skin center with lesion on upper outer of arm at the age of 18-50 years old. The patients who enroll the intervention must comply the research regulations and conductions with inform consent process. Exclusion criteria is to qualify in any of the disqualification. For examplesTCTR20210412005Faculty of Medicine, Srinakharinwirot University20
Completed
Not Applicable
A Study on the Effectiveness and Safety Evaluation of Combination Therapy With 1,927nm Thulium Laser and Fractional Microneedle Radiofrequency Equipment for Improvement of Skin AgingWrinkleNCT03739398Yonsei University26
Completed
Not Applicable
Prospective Clinical Study to Assess Safety and to Collect Data on Radiofrequency Microneedling Device(s) For the Purpose of Evaluating Treatment on SkinDermatologic ConditionsNCT06023303Cynosure, Inc.8
Completed
Not Applicable
Fractional Ablative Radiofrequency for the Treatment of Acne Scars and WrinklesWrinklesAcne ScarsNCT01645345Alma Lasers Inc.200
Completed
Not Applicable
Clinical Study To Evaluate Paired Treatment With An Alexandrite Laser And Radiofrequency Microneedling For Facial AgingDyschromiaPhotoagingWrinkleNCT05388604Cynosure, Inc.42