Clinical trial NCT04153071: Unipolar Microplasma Radiofrequency Device: In-vivo Histologic Study
Official title: Evaluation of the Cutaneous Effects of a Unipolar Microplasma Electrode Pin Radiofrequency Device: An In-vivo Histologic Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Skin Resurfacing
Lead sponsor: Alma Lasers
Sponsor class: INDUSTRY
First posted: 2019-11-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Diameter and depth of ablation and/or coagulation from varying RF device treatment parameters
timeFrame: Immediately post treatment
Secondary outcomes:
measure: Rate of adverse events
timeFrame: 10 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: Westlake Dermatology Clinical Research Center
state: Texas
Study officials:
affiliation: Westlake Dermatology Clinical Research Center
name: Daniel Friedmann, MD, FAAD
role: PRINCIPAL_INVESTIGATOR
References: