Evaluation of the Safety and Efficacy of Hyaluronic Acid Injection in Labia Majora Augmentation

Launched by BIOSCIENCE COSMETICS SL · Mar 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a product called Genefill Contour® for women who have experienced a loss of volume in the labia majora, a condition known as vulvar atrophy. The trial aims to see how well this new treatment works compared to other similar treatments already available. Women who are over 18 years old, affected by labia majora atrophy, and wish to increase the volume in that area may be eligible to participate. They should also be able to understand and provide their consent to join the study.

Participants in the trial will visit the clinic a total of 8 times over 12 months, which includes 2 phone calls for check-ins. During these visits, they will receive either the Genefill Contour® treatment or another similar treatment and will be asked about their symptoms, satisfaction, and any pain experienced during the process. It's important to note that women who are pregnant, breastfeeding, or planning to become pregnant during the study are not eligible. Additionally, those with certain medical conditions or recent treatments that could interfere with the study will also be excluded. If you are interested and think you might qualify, it could be a good opportunity to explore a new treatment for labia majora atrophy.

Gender

FEMALE

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.