Evaluation of the Safety and Efficacy of Hyaluronic Acid Injection in Labia Majora Augmentation
Recruiting
N/A
Interventional Study
Vulvar Atrophy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 110 (estimated)
- Sponsor
- Bioscience Cosmetics SL · Industry
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About This Trial
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 investigati…
Trial Locations
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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 enrolm…
Contacts