Evaluation of the Efficacy and Safety of Hyaluronic Acid Injection in Labia Majora for Volume Res… (NCT04147689) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Efficacy and Safety of Hyaluronic Acid Injection in Labia Majora for Volume Restoration
France72 participantsStarted 2019-11-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 yea…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients having an improvement on the Global Aesthetic Improvement Scale (GAIS)