Clinical trial NCT04147689: Evaluation of the Efficacy and Safety of Hyaluronic Acid Injection in Labia Majora for Volume Restoration
Official title: Evaluation of the Efficacy and Safety of Hyaluronic Acid Injection in Labia Majora for Volume Restoration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvar Atrophy
Keywords: hyaluronic acid
labia majora
vulvar
filler
hypotrophy
atrophy
Lead sponsor: Laboratoires Vivacy
Sponsor class: INDUSTRY
First posted: 2019-11-01
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One group of patient treated with DESIRIAL® PLUS (injection in labia majora)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Proportion of patients having an improvement on the Global Aesthetic Improvement Scale (GAIS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Patient self-assessed aesthetic evolution
timeFrame: 4 weeks, 24 weeks, 36 weeks, 52 weeks
measure: Patient aesthetic evolution
timeFrame: 4 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks
measure: Sexual function assessment
timeFrame: 4 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks
measure: Patient's satisfaction: questionnaire (PSQ)
timeFrame: 4 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks
measure: Assessment of patient's symptoms
timeFrame: 4 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks
measure: Patient's assessment of pain related to the injection
timeFrame: Baseline (injection)
measure: Report of adverses effects
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Creteil
country: France
facility: Chu Henri Mondor
city: Les Lilas
country: France
facility: Private office
city: Lyon
country: France
facility: CHU Croix-Rousse
city: Marseille
country: France
facility: Private office
city: Nantes
country: France
facility: Centre de la femme
city: Paris
country: France
facility: Private office
city: Paris
country: France
facility: Private office
city: Perpignan
country: France
facility: Private office
city: Rouen
country: France
facility: Clinique de l'Europe
Study officials:
name: Fabien BOUCHER, MD
role: PRINCIPAL_INVESTIGATOR
References: