Evaluation of the Efficacy and Safety of Hyaluronic Acid Injection in Labia Majora for Volume Restoration

NCT04147689 | Completed

• 1 other identifier: 2019-A01241-56
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 9

Brief Summary

DESIRIAL® PLUS is a CE-marketed hyaluronic acid (since 2011) whose registered indications are moderate hypotrophy, severe hypotrophy or atrophy of the vulvar Labia Majora by subcutaneous injections. The aim is to restore volume, rehydrate and add tone and tension to connective tissue areas by filling. In this study, 71 female subjects above or equal to 18 years old at inclusion, who have moderate hypotrophy or severe hypotrophy or atrophy of the vulvar Labia Majora (according to investigator's judgement), who have given her informed consent and meet all the eligibility criteria, will be enrolled. Subjects will come to a total of 6 visits over a period of 12 months. An optional screening visit may be done before injection (additional visit). Proportion of patients having an improved perception of aesthetics (GAIS score after mirror self-examination) after baseline injection will be assessed. Global Aesthetic Improvement, Sexual function, subject's satisfaction, subject's symptoms, pain at injection and safety will be also assessed.

Conditions

Vulvar Atrophy

Keywords

hyaluronic acid; labia majora; vulvar; filler; hypotrophy; atrophy

Outcome Measures

Primary Outcomes (1)

• Proportion of patients having an improvement on the Global Aesthetic Improvement Scale (GAIS)

  Proportion of patients having an improvement on the GAIS, evaluated by the patient (after mirror self-examination), 12 weeks after baseline injection. 5 possible grades: 1) Very much improved, 2) much improved, 3) improved, 4) no change, 5) worse

  12 weeks

Secondary Outcomes (7)

• Patient self-assessed aesthetic evolution

  4 weeks, 24 weeks, 36 weeks, 52 weeks

• Patient aesthetic evolution

  4 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks

• Sexual function assessment

  4 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks

• Patient's satisfaction: questionnaire (PSQ)

  4 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks

• Assessment of patient's symptoms

  4 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks

Study Arms (1)

Treated labia majora

EXPERIMENTAL

Labia majora are treated at Baseline visit (V1) and a touch-up may be performed 4 weeks after Baseline (V2) if needed

Device: DESIRIAL® PLUS

Interventions

DESIRIAL® PLUS DEVICE

DESIRIAL® PLUS is a cross-linked hyaluronic acid gel to restore volume by filling the labia majora, to rehydrate and to add tone and tension to the area of connective tissue. The baseline injection is performed at V1, with a maximum volume to be injected per labium of 2 ml. The exact volume will be determined by the physician in order to reach optimal volume correction. One optional touch-up injection of DESIRIAL® PLUS is allowed at V2 (4 weeks after Baseline), with a maximum volume to be injected per labium of 1 ml. No other touch-up injections are allowed until the end of the study.

Treated labia majora

Eligibility Criteria

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

You may qualify if:

• Women with the following conditions :
• Moderate hypotrophy, severe hypotrophy or atrophy of the vulvar Labia Majora, according to the investigator's judgement
• Expressed the wish for volume restoration of the Labia Majora
• Able to understand and sign the informed consent for study enrolment
• Subject affiliated to a health social security system
• General :
• Pregnancy
• Breast feeding
• Known tendency to develop hypertrophic scars or keloid scars
• Participating at the same time in another clinical trial
• Deprived of their freedom by administrative or legal decision or under guardianship
• Linked to inflammatory or immune status:
• Known hypersensitivity
• to one of DESIRIAL® PLUS's components (hyaluronic acid, mannitol)
• to the antiseptic solution that is planned to be used in this study

Sponsors & Collaborators

• Laboratoires Vivacy: lead

Study Sites (9)

Chu Henri Mondor

Créteil, 94000, France

Location

Private office

Les Lilas, 93260, France

Location

CHU Croix-Rousse

Lyon, 69004, France

Location

Private office

Marseille, 13008, France

Location

Centre de la femme

Nantes, 44000, France

Location

Private office

Paris, 75007, France

Location

Private office

Paris, 75017, France

Location

Private office

Perpignan, 66000, France

Location

Clinique de l'Europe

Rouen, 76100, France

Location

MeSH Terms

Conditions

Atrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Fabien BOUCHER, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: One group of patient treated with DESIRIAL® PLUS (injection in labia majora)

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 1, 2019
• Study Start: November 18, 2019
• Primary Completion: February 25, 2021
• Study Completion: March 30, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)