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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks, 24 weeks, 36 weeks, 52 weeks |
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Inclusion Criteria:
Women with the following conditions :
Non-inclusion Criteria
General :
Linked to inflammatory or immune status:
Known hypersensitivity
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:
Linked to neoplasia:
Linked to previous or ongoing treatments:
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| Name | Affiliation | Role |
|---|---|---|
| Fabien BOUCHER, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Henri Mondor | Créteil | 94000 | France | |||
| Private office |
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| ID | Term |
|---|---|
| D001284 | Atrophy |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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One group of patient treated with DESIRIAL® PLUS (injection in labia majora)
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| 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 |
| 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 | 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 | 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 | 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 | Baseline (injection) |
| Report of adverses effects | Evaluation of product safety by adverse event collection throughout the study | Up to 52 weeks |
| Les Lilas |
| 93260 |
| France |
| CHU Croix-Rousse | Lyon | 69004 | France |
| Private office | Marseille | 13008 | France |
| Centre de la femme | Nantes | 44000 | France |
| Private office | Paris | 75007 | France |
| Private office | Paris | 75017 | France |
| Private office | Perpignan | 66000 | France |
| Clinique de l'Europe | Rouen | 76100 | France |