Hyaluronic acid injections for labia majora augmentation

Prospective, Multicentric, Single Blind, Randomized Study on the Evaluation of the Safety and Efficacy of Genefill Contour® Versus Comparator in Labia Majora Augmentation

This study is testing a new device to see if it can safely make the labia majora fuller for women who feel theirs are too small or thin.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Bioscience Cosmetics SL (Industry-sponsored)
• Locations: 3 sites (Levallois-Perret, Paris and 2 other locations)
• Trial ID: NCT06333782 on ClinicalTrials.gov

What this trial studies

This clinical investigation evaluates the safety and efficacy of the Genefill Contour® device for augmenting the labia majora in women experiencing hypotrophy or atrophy. Participants will be randomly assigned to receive either the investigational device or a marketed comparator, Desirial®Plus, over a 12-month period with a total of 8 visits. The study aims to assess improvements in symptoms, patient satisfaction, sexual function, and pain during injection. An ancillary study will also measure changes in volume and distance between the labia after treatment.

Who should consider this trial

Good fit: Ideal candidates are women over 18 years old suffering from labia majora atrophy or hypotrophy who desire volume augmentation.

Not a fit: Patients who are pregnant, breastfeeding, or planning a pregnancy during the study will not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could provide women with improved aesthetic and functional outcomes related to labia majora augmentation.

How similar studies have performed: While there have been studies on hyaluronic acid for other cosmetic applications, this specific approach for labia majora augmentation is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Gender: female.
* Age: more than 18 years old.
* Patient affected by labia majora atrophy/hypotrophy as per investigator's judgement and expressing the wish for volume augmentation of the labia majora.
* Patient able to understand and sign the informed consent for study enrolment.
* Patient having given freely and expressly her informed consent.
* Patient affiliated to a health social security system.
* Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before inclusion and during all the study.

Exclusion Criteria:

* Pregnant or breastfeeding woman or planning a pregnancy during the study
* Women who gave birth within 4 months before inclusion.
* Patient who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
* Patient in a social or sanitary establishment.
* Patient suspected to be non-compliant according to the investigator's judgment.
* Patient suffering from a severe or progressive disease.
* Patient with history of auto immune disease.
* Patient immunosuppressed.
* Patient suffering of haemostatic disorder.
* Patient presenting with acute or chronic skin diseases.
* Patient is prone to active inflammatory or infectious processes or presenting clinical signs of inflammation in or close to the labia majora.
* Patient presenting bacterial, fungal or viral infection in or close to labia majora.
* Patient with history of streptococcal disease.
* Patient with recurrent genital herpes (several times a year). A patient asymptomatic in the 6 months before inclusion is eligible.
* Patient with history of pre-cancerous condition or cancer in areas close to the injection site (external urogenital, anal or vaginal).
* Patient with an actual cancer or presence of pre-cancerous cells (vulvar dysplasia).
* Patient with a known tendency to develop keloid or hypertrophic scars.
* Patient with known allergy or hypersensitivity to hyaluronic acid or to one of Genefill Contour, Desirial® Plus, anesthesia (if applicable) and disinfectant components.
* Patient with multiple allergies.
* Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk.
* Patient who started oestrogen therapies for treatment of vulvovaginal symptomatology within 3 months before inclusion.
* Patient under treatment for bacterial, fungal or viral infection.
* Patient under treatment with aspirin, anticoagulant, platelets aggregation inhibiting drugs, NSAIDs, immunosuppressive therapy and Vitamin C or treated within one week before inclusion.
* Patient under local hydrating treatment within four weeks before inclusion.
* Patient with history of correction with another resorbable implants with a similar indication within 12 months before inclusion.
* Patient with history of correction with permanent implants including fat graft or semi-permanent in the area of injection.
* Patient who underwent a surgery on labia minora within 12 months before inclusion.
* Patient who underwent a surgery on labia majora at any time.
* Patient having intolerance to gram-positive bacteria.

Where this trial is running

Levallois-Perret, Paris and 2 other locations

• Cabinet renaissance — Levallois-Perret, Paris, France (Recruiting)
• Palais Flore — Lyon, France (Recruiting)
• Medical Center "Tu sie leczy" — Gdansk, Gdansk, Poland (Recruiting)

Study contacts

• Study coordinator: Dalia Quwaider, PhD, MBA

Conditions Vulvar Atrophy; Labia Majora Atrophy; Labia Majora Hypotrophy; Labia Majora Augmentation; Genital rejuvenation