Vulvar AtrophyESOLANENCT04147689
Evaluation of the Efficacy and Safety of Hyaluronic Acid Injection in Labia Majora for Volume Restoration
A study testing DESIRIAL® PLUS in people with Vulvar Atrophy, run by Laboratoires Vivacy at 9 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvar Atrophy
- What is being tested?
- DESIRIAL® PLUS
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 9 sitesFrance
- Study dates
- 18 Nov 2019to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 36Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Chu Henri Mondor
Créteil, 94000
Private office
Les Lilas, 93260
CHU Croix-Rousse
Lyon, 69004
Private office
Marseille, 13008
Centre de la femme
Nantes, 44000
Private office
Paris, 75007
Private office
Paris, 75017
Private office
Perpignan, 66000
Clinique de l'Europe
Rouen, 76100
About this study
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.
Read the 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.
- Conditions
- Vulvar Atrophy
- Being tested
- DESIRIAL® PLUS
- Keywords
- hyaluronic acid, labia majora, vulvar, filler, hypotrophy, atrophy
- Medical subject headings
- Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DESIRIAL® PLUSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: DESIRIAL® PLUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (7)
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
Measured: 4 weeks, 24 weeks, 36 weeks, 52 weeks
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
Measured: 4 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks
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
Measured: 4 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks
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
Measured: 4 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks
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
Measured: 4 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks
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
Measured: Baseline (injection)
Report of adverses effects
Evaluation of product safety by adverse event collection throughout the study
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start18 Nov 2019
- Primary completion25 Feb 2021
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group of patient treated with DESIRIAL® PLUS (injection in labia majora)
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Vivacy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fabien BOUCHER, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147689
- Sponsor's protocol ID
- 2019-A01241-56
- Acronym
- ESOLANE
- Status last verified
- Apr 2022
- First submitted
- 30 Oct 2019
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Hyaluronic Acid Injection in Labia Majora for Volume Restoration
- ClinicalTrials.gov ID
- NCT04147689
- Acronym / sponsor ID
- ESOLANE / 2019-A01241-56
- Conditions
- Vulvar Atrophy
- Keywords
- hyaluronic acid, labia majora, vulvar, filler, hypotrophy, atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Laboratoires VivacyIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 1 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group of patient treated with DESIRIAL® PLUS (injection in labia majora)
| Arm | Type | Receives |
|---|---|---|
| Treated labia majora | Experimental | Device: DESIRIAL® PLUSLabia majora are treated at Baseline visit (V1) and a touch-up may be performed 4 weeks after Baseline (V2) if needed |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- ≥ 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DESIRIAL® PLUSDESIRIAL® 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. | Device | Treated labia majora |
Primary outcome
Proportion of patients having an improvement on the Global Aesthetic Improvement Scale (GAIS)
Time frame: 12 weeks
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
7 secondary outcomes
Patient self-assessed aesthetic evolution
Time frame: 4 weeks, 24 weeks, 36 weeks, 52 weeks
Patient aesthetic evolution
Time frame: 4 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks
Sexual function assessment
Time frame: 4 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks
Patient's satisfaction: questionnaire (PSQ)
Time frame: 4 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks
Assessment of patient's symptoms
Time frame: 4 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks
Patient's assessment of pain related to the injection
Time frame: Baseline (injection)
Report of adverses effects
Time frame: Up to 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Vulvar Atrophy
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Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.
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Not yet recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabien BOUCHER, MD principal investigator
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DESIRIAL® PLUS in people with Vulvar Atrophy, run by Laboratoires Vivacy at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 36 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients having an improvement on the Global Aesthetic Improvement Scale (GAIS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.