Actively Recruiting
Evaluation of the Safety and Efficacy of Hyaluronic Acid Injection in Labia Majora Augmentation
Led by Bioscience Cosmetics SL · Updated on 2024-08-09
110
Participants Needed
3
Research Sites
57 weeks
Total Duration
On this page
Sponsors
B
Bioscience Cosmetics SL
Lead Sponsor
E
Eurofins
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this interventional clinical investigation using Genefill Contour® CE marked device outside of its indication is to compare with other hyaluronic acid device already marketed for labia majora augmentation in women with labia majora hypotrophy/atrophy. The primary objective is the evaluation of the safety of Genefill Contour®. The secondary objectives is effectivenes of the investigational device (improvement of patient´s symptoms, patient´s satisfaction, sexual function \& pain during injection). Participants will come to a total of 8 visits (including 2 phone calls) over a period of 12 months. Participants would be enrolled in Genefill Contour® or comparator group. An ancillary study would be conducted in a cohort of participants evaluating the increase in volume and distance between labia after HA injection
CONDITIONS
Official 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 desire volume augmentation.
- Able to understand and sign informed consent.
- Provided free and informed consent.
- Affiliated to a health social security system.
- If of childbearing potential, using effective contraception for at least 12 weeks before and during the study.
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study.
- Gave birth within 4 months before inclusion.
- Deprived of freedom by legal decision or under guardianship.
- Residing in social or sanitary establishment.
- Judged non-compliant by investigator.
- Suffering from severe or progressive disease.
- History of autoimmune disease.
- Immunosuppressed.
- Having haemostatic disorder.
- Presenting acute or chronic skin diseases.
- Active inflammatory or infectious processes near labia majora.
- Bacterial, fungal, or viral infection near labia majora.
- History of streptococcal disease.
- Recurrent genital herpes (except if asymptomatic for 6 months before inclusion).
- History of pre-cancerous condition or cancer near injection site.
- Current cancer or vulvar dysplasia.
- Known tendency to develop keloid or hypertrophic scars.
- Known allergy or hypersensitivity to hyaluronic acid, Genefill Contour, Desirial� Plus, anesthesia, or disinfectants.
- Multiple allergies.
- Condition or medication posing undue risk per investigator judgment.
- Started estrogen therapies for vulvovaginal symptoms within 3 months before inclusion.
- Under treatment for infection.
- Under treatment with aspirin, anticoagulants, platelet inhibitors, NSAIDs, immunosuppressants, Vitamin C within one week before inclusion.
- Using local hydrating treatment within four weeks before inclusion.
- History of correction with resorbable implants within 12 months before inclusion.
- History of correction with permanent 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.
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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
CONTACT
V
Vanesa Garrido Estevez, PhD
CONTACT
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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