Unipolar Microplasma Radiofrequency Device: In-vivo Histologic Study

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Skin Resurfacing
• Intervention / Treatment: Device: OPUS system

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78746
      • Westlake Dermatology Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. The subject is less than 18 or greater than 75 years of age.
2. Subject with excessive superficial skin laxity and/or striae of the abdomen, which would prevent proper study treatment.
3. A subject that is unwilling to have punch biopsy specimens obtained from treated areas.
4. Subject with a history of allergy to lidocaine or epinephrine.
5. Known history of keloids or bleeding/coagulation disorder.
6. Presence of surgical or non-surgical scars in the area to be treated.
7. Active inflammatory or infectious process or any other active or serious skin disease in the area to be treated.
8. Planned surgical procedures with incisions and suturing in the area to be treated during the course of the study.
9. 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.
10. 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.
11. Subjects receiving antiplatelet, anticoagulant, or non-steroidal anti-inflammatory agents within 2 weeks of treatment, or planning to receive during the course of the study; in whom, in the Investigator's opinion, administration of radiofrequency treatment may cause procedure-related complications.
12. Women who are pregnant, nursing or intend to become pregnant over the duration of the study, or women who are of childbearing potential not protected by an effective contraceptive method of birth control. Pregnancy status should be checked by urine testing at baseline (Day 0).
13. Subjects who are unwilling or unable to give written consent to participate in the study or unable to comply with the requirements of the clinical trial protocol.
14. Subjects who have received an experimental drug or device within the previous 3 months prior to enrollment.
15. Subjects who are known as alcohol or drug abusers.
16. Subjects who are suffering from any physical or psychological condition, or are under treatment for any such condition which, in the opinion of the Investigator, may constitute an unwarranted risk or which may affect the subjects' compliance or adherence to study procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unipolar microplasma RF treatment; Single cutaneous unipolar microplasma RF treatment, with variable treatment parameters	Device: OPUS system; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diameter and depth of ablation and/or coagulation from varying RF device treatment parameters	Histology analysis to evaluate the diameter and depth of ablation and/or coagulation from varying microplasma RF device treatment parameters, based on biopsy specimens	Immediately post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of adverse events	Safety will be monitored by documentation of adverse events	10 days

Collaborators and Investigators

• Sponsor: Alma Lasers
• Investigators: Principal Investigator: Daniel Friedmann, MD, FAAD, Westlake Dermatology Clinical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2019
• Primary Completion (Actual): September 16, 2020
• Study Completion (Actual): September 16, 2020

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 23, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: ALM-OPUS-19-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No