Evaluation of the Cutaneous Effects of a Unipolar Microplasma Electrode Pin Radiofrequency Device: An In-vivo Histologic Study

Alma Lasers1 site in 1 countryOctober 23, 2019

ConditionsSkin Resurfacing

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Skin Resurfacing
Sponsor: Alma Lasers
Locations: 1
Primary Endpoint: Diameter and depth of ablation and/or coagulation from varying RF device treatment parameters
Status: Withdrawn
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Prospective, Open-Label, Single-Center Pilot Study.

The study is aimed to evaluate the histologic effects of a unipolar microplasma electrode pin radiofrequency device (Alma Lasers OPUS system) on the abdominal skin.

The study will include up to 2 subjects. Each subject will have a single cutaneous treatment of their lower abdomen, with variable treatment parameters. Punch biopsies will be obtained from each treatment section, for in-vivo histological evaluations.

Registry

clinicaltrials.gov

Start Date

October 23, 2019

End Date

September 16, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Alma Lasers

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject seeking surgical correction of abdominal tissue laxity with an abdominoplasty within the subsequent 1-12 months.
•Subject abdominal skin must be of appropriate quality to allow for proper study treatment, as judged by the Investigator.
•The subject must be willing to have punch biopsy specimens obtained from all treated areas following treatment.
•The Subject must sign a statement of informed consent to the Investigator and Sponsor.

Exclusion Criteria

•The subject is less than 18 or greater than 75 years of age.
•Subject with excessive superficial skin laxity and/or striae of the abdomen, which would prevent proper study treatment.
•A subject that is unwilling to have punch biopsy specimens obtained from treated areas.
•Subject with a history of allergy to lidocaine or epinephrine.
•Known history of keloids or bleeding/coagulation disorder.
•Presence of surgical or non-surgical scars in the area to be treated.
•Active inflammatory or infectious process or any other active or serious skin disease in the area to be treated.
•Planned surgical procedures with incisions and suturing in the area to be treated during the course of the study.
•Subjects who have had (or plan to have during the course of the study) an abdominal skin treatment with any exclusionary treatments, medications, and/ or devices.
•Subjects who have used oral isotretinoin or other oral retinoids during the study in the prior 12 months or planning to be on them during the course of the study.

Outcomes

Primary Outcomes

Diameter and depth of ablation and/or coagulation from varying RF device treatment parameters

Time Frame: Immediately post treatment

Histology analysis to evaluate the diameter and depth of ablation and/or coagulation from varying microplasma RF device treatment parameters, based on biopsy specimens