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

Primary Purpose

Vulvar Atrophy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
DESIRIAL® PLUS
Sponsored by
Laboratoires Vivacy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvar Atrophy focused on measuring hyaluronic acid, labia majora, vulvar, filler, hypotrophy, atrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Women with the following conditions :

  • ≥ 18 years of age at inclusion
  • 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

Non-inclusion Criteria

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
    • to amide local anesthetics or to one of the components of the anesthesia product that is planned to be used in this study
  • Presence of clinical signs of inflammatory in or close to the area of interest or treatment for these affections
  • History of or ongoing auto-immune disease
  • Suffering from hemostatic disorder

Linked to infection:

  • Presence of bacterial, fungal or viral infection in or close to the area of interest or treatment for these affections
  • History of streptococcal illness (such as recurrent sore throat or acute articular rheumatism)
  • Recurrent genital herpes (several times a year)

Linked to neoplasia:

  • History of cancer in areas close to the injection site (external urogenital, anal or vaginal)
  • Actual cancer or presence of pre-cancerous cells (e.g. vaginal dysplasia)

Linked to previous or ongoing treatments:

  • Under treatment with aspirin, anticoagulant, platelets aggregation inhibiting drugs, NSAIDs and Vitamin C or treated within 1 week prior to inclusion
  • Under local hyaluronic acid-like hydrating treatment within 4 weeks prior to inclusion
  • History of hyaluronic acid injection of >14 ml in any part of the body within the last year
  • History of correction with DESIRIAL® range or other resorbable implants with similar indication within 1 year prior to inclusion
  • History of correction with permanent implants including fat graft or semi-permanent in the area of injection
  • Surgical history on Labia Minora within one year prior inclusion
  • Surgical history on Labia Majora

Sites / Locations

  • Chu Henri Mondor
  • Private office
  • CHU Croix-Rousse
  • Private office
  • Centre de la femme
  • Private office
  • Private office
  • Private office
  • Clinique de l'Europe

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treated labia majora

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient self-assessed aesthetic evolution
Patient self-assessed aesthetic evolution (after mirror self-examination) using GAIS evaluated 4, 24, 36 and 52 weeks after baseline injection. 5 possible grades: 1) Very much improved, 2) much improved, 3) improved, 4) no change, 5) worse
Patient aesthetic evolution
Patient aesthetic evolution evaluated by the Investigator (after visual observation) using GAIS evaluated 4, 12, 24, 36 and 52 weeks after baseline injection. 5 possible grades: 1) Very much improved, 2) much improved, 3) improved, 4) no change, 5) worse
Sexual function assessment
Sexual function assessment by Female Sexual Function Index (FSFI) score self-evaluated 4, 12, 24, 36 and 52 weeks after baseline injection. Auto-questionnaire with 19 multiple choice questions to measure the sexual functioning in women
Patient's satisfaction: questionnaire (PSQ)
Patient's satisfaction using a questionnaire (PSQ) evaluated 4, 12, 24, 36 and 52 weeks after baseline injection. Questionnaire with 5 questions answerable by 4 choices: not at all, a little, a lot, totally
Assessment of patient's symptoms
Assessment of patient's symptoms related to atrophy or hypotrophy of the vulvar Labia Majora (irritation/burning during daily life, irritation/burning during sport, and itching) using a Numerical Rating Scale (NRS) evaluated 4, 12, 24, 36 and 52 weeks after baseline injection. Graded scale from 0 (absent) to 10 (intolerable) in increments of 1
Patient's assessment of pain related to the injection
Patient's assessment of pain related to the injection, measured on a NRS during injection. Graded scale from 0 (no pain) to 10 (worst possible pain) in increments of 1
Report of adverses effects
Evaluation of product safety by adverse event collection throughout the study

Full Information

First Posted
October 30, 2019
Last Updated
April 6, 2022
Sponsor
Laboratoires Vivacy
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1. Study Identification

Unique Protocol Identification Number
NCT04147689
Brief Title
Evaluation of the Efficacy and Safety of Hyaluronic Acid Injection in Labia Majora for Volume Restoration
Acronym
ESOLANE
Official Title
Evaluation of the Efficacy and Safety of Hyaluronic Acid Injection in Labia Majora for Volume Restoration
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 18, 2019 (Actual)
Primary Completion Date
February 25, 2021 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires Vivacy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
ESOLANE is a prospective multicenter post-marketing study of a class III medical device. This uncontrolled open-label study investigates the efficacy and safety of DESIRIAL® PLUS in volume restoration of Labia Majora. The study duration is 12 months with an optional screening visit (V0) up to 14 days before injection, the baseline visit (injection of DESIRIAL®PLUS, V1) and 5 follow-up visits after 4, 12, 24, 36 and 52 weeks (V2 to V6). At 4 weeks (V2) an optional touch-up may be done (if needed). It is envisaged to enrol 71 female patients with the wish for volume restoration in France to obtain at least 60 evaluable patients, which will be monitored over 1 year after baseline injection of DESIRIAL® PLUS. The primary endpoint is defined as the proportion of patients having an improved perception of aesthetics (GAIS score after mirror self-examination) at 12 weeks after baseline injection of DESIRIAL® PLUS, which may be touched-up once after 4 weeks (V2). Global Aesthetic Improvement (evaluated by the patient and the doctor), Sexual function, subject's satisfaction, subject's symptoms & pain, will be measured at all time-point with a Global Aesthetic Improvement Scale (GAIS), Female Sexual Function Index (FSFI), patient's satisfaction questionnaire (PSQ) and a Numerical Rating Scale (NRS) respectively. Safety will be also assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Atrophy
Keywords
hyaluronic acid, labia majora, vulvar, filler, hypotrophy, atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One group of patient treated with DESIRIAL® PLUS (injection in labia majora)
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treated labia majora
Arm Type
Experimental
Arm Description
Labia majora are treated at Baseline visit (V1) and a touch-up may be performed 4 weeks after Baseline (V2) if needed
Intervention Type
Device
Intervention Name(s)
DESIRIAL® PLUS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients having an improvement on the Global Aesthetic Improvement Scale (GAIS)
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Patient self-assessed aesthetic evolution
Description
Patient self-assessed aesthetic evolution (after mirror self-examination) using GAIS evaluated 4, 24, 36 and 52 weeks after baseline injection. 5 possible grades: 1) Very much improved, 2) much improved, 3) improved, 4) no change, 5) worse
Time Frame
4 weeks, 24 weeks, 36 weeks, 52 weeks
Title
Patient aesthetic evolution
Description
Patient aesthetic evolution evaluated by the Investigator (after visual observation) using GAIS evaluated 4, 12, 24, 36 and 52 weeks after baseline injection. 5 possible grades: 1) Very much improved, 2) much improved, 3) improved, 4) no change, 5) worse
Time Frame
4 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks
Title
Sexual function assessment
Description
Sexual function assessment by Female Sexual Function Index (FSFI) score self-evaluated 4, 12, 24, 36 and 52 weeks after baseline injection. Auto-questionnaire with 19 multiple choice questions to measure the sexual functioning in women
Time Frame
4 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks
Title
Patient's satisfaction: questionnaire (PSQ)
Description
Patient's satisfaction using a questionnaire (PSQ) evaluated 4, 12, 24, 36 and 52 weeks after baseline injection. Questionnaire with 5 questions answerable by 4 choices: not at all, a little, a lot, totally
Time Frame
4 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks
Title
Assessment of patient's symptoms
Description
Assessment of patient's symptoms related to atrophy or hypotrophy of the vulvar Labia Majora (irritation/burning during daily life, irritation/burning during sport, and itching) using a Numerical Rating Scale (NRS) evaluated 4, 12, 24, 36 and 52 weeks after baseline injection. Graded scale from 0 (absent) to 10 (intolerable) in increments of 1
Time Frame
4 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks
Title
Patient's assessment of pain related to the injection
Description
Patient's assessment of pain related to the injection, measured on a NRS during injection. Graded scale from 0 (no pain) to 10 (worst possible pain) in increments of 1
Time Frame
Baseline (injection)
Title
Report of adverses effects
Description
Evaluation of product safety by adverse event collection throughout the study
Time Frame
Up to 52 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women with the following conditions : ≥ 18 years of age at inclusion 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 Non-inclusion Criteria 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 to amide local anesthetics or to one of the components of the anesthesia product that is planned to be used in this study Presence of clinical signs of inflammatory in or close to the area of interest or treatment for these affections History of or ongoing auto-immune disease Suffering from hemostatic disorder Linked to infection: Presence of bacterial, fungal or viral infection in or close to the area of interest or treatment for these affections History of streptococcal illness (such as recurrent sore throat or acute articular rheumatism) Recurrent genital herpes (several times a year) Linked to neoplasia: History of cancer in areas close to the injection site (external urogenital, anal or vaginal) Actual cancer or presence of pre-cancerous cells (e.g. vaginal dysplasia) Linked to previous or ongoing treatments: Under treatment with aspirin, anticoagulant, platelets aggregation inhibiting drugs, NSAIDs and Vitamin C or treated within 1 week prior to inclusion Under local hyaluronic acid-like hydrating treatment within 4 weeks prior to inclusion History of hyaluronic acid injection of >14 ml in any part of the body within the last year History of correction with DESIRIAL® range or other resorbable implants with similar indication within 1 year prior to inclusion History of correction with permanent implants including fat graft or semi-permanent in the area of injection Surgical history on Labia Minora within one year prior inclusion Surgical history on Labia Majora
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabien BOUCHER, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Henri Mondor
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Private office
City
Les Lilas
ZIP/Postal Code
93260
Country
France
Facility Name
CHU Croix-Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Private office
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Centre de la femme
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Private office
City
Paris
ZIP/Postal Code
75007
Country
France
Facility Name
Private office
City
Paris
ZIP/Postal Code
75017
Country
France
Facility Name
Private office
City
Perpignan
ZIP/Postal Code
66000
Country
France
Facility Name
Clinique de l'Europe
City
Rouen
ZIP/Postal Code
76100
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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