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
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.
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.
Parallel
Experimental- Genefill Contour®
DeviceGenefill Contour® Hyaluronic Acid Injection
Marketed comparator - Desirial®Plus
DeviceDESIRIAL®PLUS Hyaluronic Acid Injection
Mean of number of occurred ADEs (Adverse device effects)
Collection of ADEs by patients having received injection with Genefill Contour versus Desirial Plus after 52 weeks of use
Global Aesthetic Improvement Scale (GAIS) assessment by investigator
Effectiveness of investigational device versus comparator assessed by the investigator using GAIS. GAIS score (1-5) as following: 1 =very much improved 2= Much improved 3=Improved 4= No change 5= Worse
Global Aesthetic Improvement Scale (GAIS) assessment by participant
Effectiveness of investigational device versus comparator assessed by the participant using GAIS. GAIS score (1-5) as following: 1 =very much improved 2= Much improved 3=Improved 4= No change 5= Worse
Patient (Atrophy/Hypotrophy) symptoms
Effectiveness of investigational device (Genefill Contour) versus comparator (Desirial Plus) on patient's symptoms. A scale from 0 (abscent) to 10 (intolerance) of the following symptoms: * Irritation/Burning during daily life * Irritation/Burning during sport * Iching * Stinging * Dryness
Sexual function Assessment, The Female Sexual Function Index (FSFI)
Effectiveness of investigational device Genefill Contour) versus comparator (Desirial Plus) on sexual function. Patient will be asked about her sexual life, and the answers will be scored from 1 to 5, being 1 as the worst situation and 5 the best.
Click on the lead sponsor to view all of their trials.
Bioscience Cosmetics SL
Lead sponsor
Eurofins
Collaborator
