Evaluation of the Safety and Efficacy of Hyaluronic Acid Injection in Labia Majora Augmentation

Official title

Prospective, Multicentric, Single Blind, Randomized Study on the Evaluation of the Safety and Efficacy of Genefill Contour® Versus Comparator in Labia Majora Augmentation

Overview

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

Detailed description

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.

Interventions

• Device Experimental- Genefill Contour®
  Genefill Contour® Hyaluronic Acid Injection
• Device Marketed comparator - Desirial®Plus
  DESIRIAL®PLUS Hyaluronic Acid Injection

Primary outcome measures

• Mean of number of occurred ADEs (Adverse device effects) [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.]

Secondary outcome measures (7)

• Global Aesthetic Improvement Scale (GAIS) assessment by investigator [Time frame: Week 4, Week 12, Week 24 & Week 52]
• Global Aesthetic Improvement Scale (GAIS) assessment by participant [Time frame: Week 4, Week 12, Week 24 & Week 52]
• Patient (Atrophy/Hypotrophy) symptoms [Time frame: Week 4, Week 12, Week 24 & Week 52]
• Sexual function Assessment, The Female Sexual Function Index (FSFI) [Time frame: Week 4, Week 12, Week 24, Week 36 & Week 52]
• Patient´s satisfaction [Time frame: Week 4, Week 12, Week 24, Week 36 & Week 52]
• Pain during injection-Visual Analogical Scale (VAS) [Time frame: After the injection at Visit 1 (Day 0) and Visit 2 ( Week 4)]
• Adverse Events collection (Global safety during the study period) [Time frame: During the whole study, up to 52 weeks]

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 enrolment.
• Patient having given freely and expressly her informed consent.
• Patient affiliated to a health social security system.
• Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before inclusion and during all the study.

Exclusion criteria

• 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.
• Patient suspected to be non-compliant according to the investigator's judgment.
• Patient suffering from a severe or progressive disease.
• Patient with history of auto immune disease.
• Patient immunosuppressed.
• Patient suffering of haemostatic disorder.
• Patient presenting with acute or chronic skin diseases.
• Patient is prone to active inflammatory or infectious processes or presenting clinical signs of inflammation in or close to the labia majora.
• Patient presenting bacterial, fungal or viral infection in or close to labia majora.
• Patient with history of streptococcal disease.
• Patient with recurrent genital herpes (several times a year). A patient asymptomatic in the 6 months before inclusion is eligible.
• Patient with history of pre-cancerous condition or cancer in areas close to the injection site (external urogenital, anal or vaginal).
• Patient with an actual cancer or presence of pre-cancerous cells (vulvar dysplasia).
• Patient with a known tendency to develop keloid or hypertrophic scars.
• Patient with known allergy or hypersensitivity to hyaluronic acid or to one of Genefill Contour, Desirial® Plus, anesthesia (if applicable) and disinfectant components.
• Patient with multiple allergies.
• Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk.
• Patient who started oestrogen therapies for treatment of vulvovaginal symptomatology within 3 months before inclusion.
• Patient under treatment for bacterial, fungal or viral infection.
• Patient under treatment with aspirin, anticoagulant, platelets aggregation inhibiting drugs, NSAIDs, immunosuppressive therapy and Vitamin C or treated within one week before inclusion.
• Patient under local hydrating treatment within four weeks before inclusion.
• Patient with history of correction with another resorbable implants with a similar indication within 12 months before inclusion.
• Patient with history of correction with permanent implants including fat graft or semi-permanent in the area of injection.
• Patient who underwent a surgery on labia minora within 12 months before inclusion.
• Patient who underwent a surgery on labia majora at any time.
• Patient having intolerance to gram-positive bacteria.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

France · 2 centers

• Cabinet renaissance — Levallois-Perret
• Palais Flore — Lyon

Poland · 1 center

• Medical Center "Tu sie leczy" — Gdansk

Identifiers

NCT: NCT06333782 · 2023-EU-GEN-01 · 2023-A02012-43

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗