Unipolar Microplasma Radiofrequency Device: In-vivo Histologic Study

Skin Resurfacing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04153071
• Other study ID #: ALM-OPUS-19-010
• Status: Withdrawn
• Phase: N/A
• Start date: October 23, 2019
• Est. completion date: September 16, 2020

Study information

• Verified date: November 2019
• Source: Alma Lasers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 16, 2020
• Est. primary completion date: September 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Skin Resurfacing

Intervention

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.

Locations

Country	Name	City	State
United States	Westlake Dermatology Clinical Research Center	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alma Lasers

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of adverse events	Safety will be monitored by documentation of adverse events	10 days