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The Use of J-Plasma® for Dermal Resurfacing

NCT03286283 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2022-07-27

Study results available
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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.

Conditions

  • Facial Wrinkles
  • Rhytides

Interventions

DEVICE

J-Plasma

Dermal resurfacing procedure with J-Plasma.

Sponsors & Collaborators

  • Apyx Medical

    lead INDUSTRY

Principal Investigators

  • Cindy Ponce, BS(ACS) · Apyx Medical (formerly Bovie Medical Corporation)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-22
Primary Completion
2018-08-20
Completion
2018-11-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03286283 on ClinicalTrials.gov