Actively Recruiting
Prospective, Multicentric, Single Blind, Randomized Study on the Safety and Efficacy of Genefill Contour4 Versus Comparator in Labia Majora Augmentation
Led by Bioscience Cosmetics SL · Updated on 2024-08-09
110
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Bioscience Cosmetics SL
Lead Sponsor
E
Eurofins
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to compare the safety and effectiveness of the Genefill Contour4 hyaluronic acid device with another marketed hyaluronic acid device, Desirial Plus, for labia majora augmentation in women experiencing labia majora hypotrophy or atrophy. The study focuses primarily on assessing the safety of Genefill Contour4 and also evaluates patient symptoms, satisfaction, sexual function, and pain during injection. An additional study within this trial will measure changes in labia volume and distance after treatment. Participants will be randomly assigned to receive injections of either Genefill Contour4 or the comparator Desirial Plus. Injections are given at the first visit, with an optional touch-up at week 4 if needed. The trial lasts for 12 months and involves a total of 8 visits, including screening, five in-person visits, and two phone calls. Both devices are administered similarly, and the study is single-blinded. During the study, participants will be closely monitored through multiple assessments, including the Global Aesthetic Improvement Scale evaluated by both investigators and participants at weeks 4, 12, 24, and 52. Sexual function and patient satisfaction are tracked periodically, along with pain during injections and overall adverse events. The main safety measure is the number of adverse device effects within the first 8 weeks after injection. This comprehensive monitoring continues throughout the 12-month study period to gather detailed safety and effectiveness data.
CONDITIONS
Brief Title
Evaluation of the Safety and Efficacy of Hyaluronic Acid Injection in Labia Majora Augmentation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female gender.
- Age over 18 years.
- Diagnosed with labia majora atrophy or hypotrophy and desires volume augmentation.
- Able to understand and sign informed consent.
- Has given informed consent freely and expressly.
- Affiliated to a health social security system.
- Female of childbearing potential using effective contraception for at least 12 weeks before and throughout the study.
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study.
- Gave birth within 4 months prior to inclusion.
- Deprived of freedom by legal or administrative decision or under guardianship.
- Patient in social or sanitary establishment.
- Suspected non-compliance by investigator judgment.
- Suffering from severe or progressive disease.
- History of autoimmune disease.
- Immunosuppressed.
- Haemostatic disorder.
- Acute or chronic skin diseases.
- Active inflammatory or infectious signs near labia majora.
- Bacterial, fungal, or viral infection near labia majora.
- History of streptococcal disease.
- Recurrent genital herpes unless asymptomatic for 6 months before inclusion.
- History of precancerous condition or cancer near injection site.
- Current cancer or vulvar dysplasia.
- Known tendency for keloid or hypertrophic scars.
- Allergy or hypersensitivity to hyaluronic acid, study devices, anesthesia, or disinfectants.
- Multiple allergies.
- Condition or medication posing undue risk per investigator.
- Started estrogen therapies for vulvovaginal symptoms within 3 months before inclusion.
- Under treatment for infection.
- Under treatment with aspirin, anticoagulants, NSAIDs, immunosuppressants, or Vitamin C within one week before inclusion.
- Under local hydrating treatment within 4 weeks before inclusion.
- History of correction with resorbable implants within 12 months.
- History of correction with permanent, fat graft, or semi-permanent implants in injection area.
- Surgery on labia minora within 12 months before inclusion.
- Surgery on labia majora at any time.
- Intolerance to gram-positive bacteria.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks
Participants receive an injection with either the investigational device Genefill Contour® or the marketed comparator Desirial®Plus. An optional touch-up injection may be conducted at Week 4 if needed.
1 injection visit and 1 optional touch-up visit (both in-person)
Duration - Up to 12 months
Participants are assessed for safety, symptom improvement, satisfaction, and sexual function through scheduled visits and phone calls over 12 months.
5 in-person visits and 2 phone calls over 52 weeks
Trial Site Locations
Total: 3 locations
1
Cabinet renaissance
Levallois-Perret, Paris, France, 92300
Actively Recruiting
2
Palais Flore
Lyon, France, 69006
Actively Recruiting
3
Medical Center "Tu sie leczy"
Gdansk, Gdansk, Poland
Actively Recruiting
Research Team
D
Dalia Quwaider, PhD, MBA
V
Vanesa Garrido Estevez, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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