NCT03286283

The Use of J-Plasma® for Dermal Resurfacing

A Prospective, Multicenter, Single Arm Clinical Study Evaluating the Use of J-Plasma® for Dermal Resurfacing

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Apyx Medical · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the safety and effectiveness of J-Plasma in the reduction of facial wrinkles and rhytides. It is a multi-center, single arm, evaluator-blind prospective study of 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides and will be conducted at up to 5 investigational centers in the United States. Each study subject will receive one procedure with J-Plasma at enrollment. Follow-up will occur immediately following the procedure, at 10 days, 1, 3, and 6 months after enrollment.

Detailed description

The study objective is to demonstrate the safety and efficacy of the J-Plasma system for use in dermal skin resurfacing. This is a multi-center, single arm, evaluator-blind prospective study of 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides at up to 5 investigational centers in the United States. Study subjects that meet study eligibility criteria and have provided informed consent will be enrolled in the study. During the procedure, the investigators will use J-Plasma on applicable facial zones to reduce wrinkles and rhytides. Study subjects will be followed immediately following the procedure, at 10 days, 1, 3, and 6 months post-procedure for study assessments. Study enrollment is expected to occur over 3-6 months. Imaging and study assessments will continue through 6 months post-procedure. Total study duration is expected to be approximately 9-12 months. Primary study endpoints will be assessed at 3 months following the procedure.

Conditions

• Facial Wrinkles
• Rhytides

Interventions

Type	Name	Description
DEVICE	J-Plasma	Dermal resurfacing procedure with J-Plasma.

Timeline

• Start date: 2018-01-22
• Primary completion: 2018-08-20
• Completion: 2018-11-16
• First posted: 2017-09-18
• Last updated: 2022-07-27
• Results posted: 2019-08-07

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study