What side effects are associated with this type of intervention?

Labiaplasty, a surgical procedure aimed at reducing excess skin in the labia majora and/or minora, can have several side effects. Common side effects include pain, swelling, and bruising in the treated area. Patients may also experience temporary numbness or changes in sensation. In some cases, there can be complications such as infection, scarring, asymmetry, or dissatisfaction with the aesthetic outcome. It is important for patients to discuss these potential risks with their healthcare provider before undergoing the procedure.

What prior FDA approvals exist?

There is no specific mention of FDA-approved drugs for the treatment of labial hypertrophy in the provided context. The primary treatment for labial hypertrophy, as discussed, is labiaplasty, which involves the surgical removal or reshaping of excess skin in the labia majora and/or minora. This procedure addresses issues caused by childbirth, trauma, aging, genetics, or congenital conditions. Non-surgical treatments or drugs specifically approved for labial hypertrophy are not detailed in the provided information.

What other types of research exist?

A promising, novel alternative to labiaplasty for labial hypertrophy patients is the Renuvion APR System. This system aims to reduce lax or loose skin in the labia majora and/or minora, offering a less invasive option compared to traditional surgical methods.

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Plasma Device

Renuvion APR System for Labial Hypertrophy

N/A

Waitlist Available

Led By Paul G Ruff, MD

Research Sponsored by Apyx Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female subjects, ages 35 - 70 years old

ASA Physical Status Classification System Class I and Class II subjects

Must not have

Subjects presenting with ASA Physical Status Classification System Classes III or higher

Active systemic or local skin disease that may alter wound healing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-treatment, day 1, 14, 30, 90, 180

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the Renuvion APR System, which uses energy to tighten loose skin in the labia. It targets women who have sagging skin due to various reasons and offers a less invasive option compared to traditional surgery. Renuvion, previously branded as J-Plasma, has FDA clearance and is used in procedures like liposuction.

Who is the study for?

This trial is for women aged 35-70 with moderate to severe labial enlargement who are in good health (ASA Class I or II). Participants must agree to use birth control if applicable, not undergo other treatments in the area during the study, and allow their photos to be used. Those with mild labial protrusion, serious health issues, allergies to local anesthetics, a history of keloid scarring or electronic implants cannot join.

What is being tested?

The Renuvion APR System is being tested as a treatment for reducing loose skin in the labia due to various causes like childbirth or aging. The study will evaluate its effectiveness and safety through follow-up visits and assessments.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include reactions similar to those from surgical procedures such as pain at the site of treatment, swelling, bruising, infection risk and possible scarring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged between 35 and 70.

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I am in good or mild systemic disease health according to the ASA classification.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My health is severely impacted by my disease.

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I have a skin condition that could affect healing.

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I have cancerous or pre-cancerous spots where treatment is planned.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-treatment, day 1, 14, 30, 90, 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-treatment, day 1, 14, 30, 90, 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-treatment, day 1, 14, 30, 90, 180 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Analysis of adverse events through the 180-day post-treatment visit.

Evaluation of change between baseline and follow-up images as determined by a masked, qualitative assessment of photographs at 90-days and 180-days post-treatment compared to baseline.

Secondary study objectives

Analysis of days until subject was comfortable returning to sex.

Analysis of hypertrophy of the labia minora (Hipertrofia de Ninfas13) at baseline, D30, D90, and D180

Analysis of labia protrusion (distance of the lateral edge of the labia minora from that of the labia majora rather than the introitus) at baseline, D30, D90, and D180.

+7 more

Other study objectives

Analysis of pre- and post-treatment genital (right and left labia majora and minora) vibratory perception measurements utilizing a biothesiometer. Readings may be conducted at each follow-up visit until measurements have returned to baseline.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Procedure with the Renuvion APR System in the labiaExperimental Treatment1 Intervention

The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Renuvion APR System

2021

N/A

~60

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Labiaplasty is a surgical procedure aimed at reducing excess skin in the labia majora and/or minora. The mechanism of action involves the precise removal or reshaping of the redundant labial tissue, which can be due to factors such as childbirth, trauma, aging, genetics, or congenital conditions. This procedure is significant for patients as it can alleviate physical discomfort, improve hygiene, and enhance the aesthetic appearance of the genital area, thereby potentially boosting the patient's self-esteem and quality of life.