CompletedNot Applicable

Renuvion APR Device to Improve the Appearance of Lax Tissue in the Neck and Submental Region

United States82 participantsStarted 2019-11-26

Plain-language summary

This is a prospective, multi-center, multi-phase, evaluator-blinded study of subjects undergoing a procedure with the Renuvion APR Device to improve the appearance of lax tissue in the neck and submental region.

Who can participate

Age range35 Years – 65 Years

SexALL

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Inclusion criteria

✓. Male or female subjects 35-65 years of age (inclusive).
✓. Healthy as determined by the investigator examining the subject.
✓. Seeking improvement of the appearance of lax tissue in the neck and submental region.
✓. Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation.
✓. Willing and able to comply with protocol requirements, including obtaining study-required images/photos and assessments, and returning for follow-up visits.
✓. Willing to release rights for the use of study photos, including in potential publication.
✓. Understands and accepts the obligation not to have significant weight loss or weight gain (≥8 pounds) post the treatment, and for the duration of participation in the study.
✓. Willing to abstain from the use of blood thinners (including, but not limited to, Coumadin, NSAIDS, Ibuprofen, vitamin K, other) for 2 weeks (14 days) prior to the procedure.

Exclusion criteria

✕. Pregnant or lactating.
✕. Pregnancy within 12 months prior to screening.
✕. Use within 24 hours preceding surgery of ibuprofen, acetaminophen, any other analgesics, anti-inflammatory products, or any products including herbals and supplements that could interfere with the clinical assessments of this study (other than drugs used for anesthesia).
✕. Allergy to tumescent anesthetic (lidocaine/epinephrine).
✕. Excessive subcutaneous fat in the treatment area (as determined by the treating investigator).
✕. Active systemic or local skin disease that may alter wound healing.
✕. Significant or uncontrolled medical condition that, in the opinion of the investigator, participation in the study may compromise the patient's health.
✕. Severe solar elastosis.

What they're measuring

Day 180 Number of Participants With Improvement Measured By Independent Photographic Review

Timeframe: 180-Day

Subject Reported Pain - None to Moderate

Timeframe: Day 7

Trial details

NCT IDNCT04146467

SponsorApyx Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-02-28

Results submitted2022-04-29

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