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

NCT06333782 | Recruiting DMC

• 2 other identifiers: 2023-EU-GEN-012023-A02012-43
• Study Type: interventional
• Target: 110
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Vulvar Atrophy

Keywords

Labia Majora Atrophy; Labia Majora Hypotrophy; Labia Majora Augmentation; Genital rejuvenation

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (7)

• Global Aesthetic Improvement Scale (GAIS) assessment by investigator

  Week 4, Week 12, Week 24 & Week 52

• Global Aesthetic Improvement Scale (GAIS) assessment by participant

  Week 4, Week 12, Week 24 & Week 52

• Patient (Atrophy/Hypotrophy) symptoms

  Week 4, Week 12, Week 24 & Week 52

• Sexual function Assessment, The Female Sexual Function Index (FSFI)

  Week 4, Week 12, Week 24, Week 36 & Week 52

• Patient´s satisfaction

  Week 4, Week 12, Week 24, Week 36 & Week 52

Study Arms (2)

Genefill Contour®

EXPERIMENTAL

Participants will be injected with the investigational device Genefill Contour at Visit 1, and Visit 2 only if touch-up needed.

Device: Experimental- Genefill Contour®

Comparator (Desirial®Plus)

ACTIVE COMPARATOR

Participants would be injected with the marketed comparator (Desirial Plus) at Visit 1, and Visit 2 only if touch-up needed.

Device: Marketed comparator - Desirial®Plus

Interventions

Experimental- Genefill Contour® DEVICE

Genefill Contour® Hyaluronic Acid Injection

Genefill Contour®

Marketed comparator - Desirial®Plus DEVICE

DESIRIAL®PLUS Hyaluronic Acid Injection

Comparator (Desirial®Plus)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or breastfeeding woman or planning a pregnancy during the study
• 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 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.

Sponsors & Collaborators

• Bioscience Cosmetics SL: lead
• Eurofins: collaborator

Study Sites (3)

Cabinet renaissance

Levallois-Perret, Paris, 92300, France

RECRUITING

Palais Flore

Lyon, 69006, France

RECRUITING

Medical Center "Tu sie leczy"

Gdansk, Gdansk, Poland

RECRUITING

Study Officials

• Dalia Quwaider, PhD, MBA

  Bioscience Cosmetics

  STUDY DIRECTOR

Central Study Contacts

Dalia Quwaider, PhD, MBA

CONTACT

0034616711638; Dalia.quwaider@biosciencegmbh.com

Vanesa Garrido Estevez, PhD

CONTACT

0034679213437; Vanesa.garrido@biosciencegmbh.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants would be randomized on two groups: Genefill Contour or comparator (Desirial Plus) at a ratio 1:1

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: March 27, 2024
• Study Start: May 22, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); PL (1)