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
Prospective, Multicentric, Single Blind, Randomized study on the evaluation of the safety and efficacy of Genefill Contour versus comparator in labia majora augmentation. This study analyze the safety and efficacy of the investigational device versus comparator. Participants would be randomized 1:1 between 2 arms (Genefill Contour vs comparator). The study duration is 12 months and will consist in 8 visits (Screening visit, 5 on site visit and 2 phone calls). At week 4, an optional touch-up may be conducted. 110 participants are expected to be included in the trial. 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). An ancillary study would be conducted in a cohort of participants evaluating the increase in volume and distance between labia after HA injection at W4 and W12.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
110
Genefill Contour® Hyaluronic Acid Injection
DESIRIAL®PLUS Hyaluronic Acid Injection
Cabinet renaissance
Levallois-Perret, Paris, France
RECRUITINGPalais Flore
Lyon, France
RECRUITINGMedical Center "Tu sie leczy"
Gdansk, Gdansk, Poland
RECRUITINGMean 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
Time frame: During 4 weeks after injection: from Visit 1 to Visit 2 (week 4) and from Visit 2 (week 4) to week 8 only if Touch-up done at Visit 2.
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
Time frame: Week 4, Week 12, Week 24 & Week 52
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
Time frame: Week 4, Week 12, Week 24 & Week 52
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
Time frame: Week 4, Week 12, Week 24 & Week 52
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.
Time frame: Week 4, Week 12, Week 24, Week 36 & Week 52
Patient´s satisfaction
Effectiveness of investigational device (Genefill Contour) versus comparator (Desirial Plus) on patient's satisfaction. The patient will be asked about global satisfaction of the treatment and results. The options of the answers are as follows: * Very satisfied * Satisfied * Unsatisfied * Very Unsatisfied
Time frame: Week 4, Week 12, Week 24, Week 36 & Week 52
Pain during injection-Visual Analogical Scale (VAS)
Pain assessed by participant immediatly after the injection using Visual Analogical Scale (VAS) at Visit 1 and Visit 2 (only if touch-up is needed). The rating is from 0 cm (No pain) to 10 cm(Worst pain possible)
Time frame: After the injection at Visit 1 (Day 0) and Visit 2 ( Week 4)
Adverse Events collection (Global safety during the study period)
Collection of unsolicited adverse events from screening Visit to 52 weeks after first injection. AE severity range of grades: 0=mild 1. moderate 2. Severe
Time frame: During the whole study, up to 52 weeks
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