Clinical trial NCT06797167: POST-MARKETING CLINICAL STUDY to EVALUATE the EFFICACY and SAFETY of the VAGINAL FILLER MEDICAL DEVICE in CORRECTING THINNING of the GENITAL TISSUE of the LABIA MAJORA in WOMEN, RE-PROPORTIONING the FEMALE EXTERNAL GENITAL AREA and IMPROVING SEXUAL FUNCTION.
Official title: A POST-MARKET, CONFIRMATORY, INTERVENTIONAL CLINICAL INVESTIGATION to EVALUATE the PERFORMANCE and SAFETY of VAGINAL FILLER for the CORRECTION of ATROPHY of the FEMALE EXTERNAL GENITAL AREAS (LABIA MAJORA), RE-PROPORTIONING the RATIO BETWEEN LABIA MINORA and LABIA MAJORA and AMELIORATING SEXUAL FUNCTIONS.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrophy Vulva
Lead sponsor: Rose Pharma SA
Sponsor class: INDUSTRY
Collaborators: name: 1Med
First posted: 2025-01-28
Enrollment: 76
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 76 subjects are enrolled and randomly assigned to one of the two arms with a 1:1 ratio.

38 subjects will receive the investigational product Vaginal Filler according to the Instruction For Use (IFU); the control group will consist of 38 untreated subjects.
Primary purpose: TREATMENT

Brief summary: The overall aim of this research is to gather more information on the effectiveness of the Vaginal Filler medical device used in women to correct the thinning of the external genital tissue of the labia majora, re-proportioning its volume in relation to the labia minora and improving sexual function. It will also collect data about the safety and tolerability of Vaginal Filler.

The main question it aims to answer is:

• Does the treatment with Vaginal Filler medical device lead to an improvement of sexual functions in women with atrophy of female external genitalia (labia major)?

Researchers will compare subjects treated with Vaginal Filler medical device to untreated subjects to better study the effectiveness and also the undesirable effects of Vaginal Filler and to guarantee scientifically valid and bias-free results.

Participants will:

* receive the Vaginal Filler device via microinjections into the labia majora, if assigned to the Vaginal Filler treatment group;
* Attend the clinic for 6 scheduled visits: screening visit (V-1), baseline visit (V0) with the execution of the treatment and 4 subsequent follow-up visits (V1, V2, V3, V4) carried out 2 weeks, 1, 3 and 6 months after V0. The total duration of the study will be approximately 6 months;
* Keep a daily diary of any disorders, health problems or adverse events that may occur;
* Complete some questionnaires during the visits to the clinic.

Detailed description: With the natural ageing process, the entire body is affected by structural and morphological physical changes, including the female external genitalia (vulva). These tend to wither and lose the characteristics of youthful age, compromising the sexual sphere and quality of life.

This phenomenon depends on the physiological hormonal changes typical of menopause, which inevitably lead to major aesthetic, physical and psychological changes.

The female genital apparatus, around the age of 40 to 50, changes not only due to advancing age but also due to the lack of oestrogen (the main female sex hormones), which progressively decreases until it disappears, leading to a progressive change in the structure of the vaginal and vulvar tissue.

The decrease in hyaluronic acid, elastic fibres, collagen, and the fatty layer results in a macroscopic loss of volume, noticeable skin laxity, and a change in the ratio between the labia majora and labia minora, which causes the latter to protrude more.

The reduced volume and change in the shape of the labia majora compromise their protective function of the internal structures, exposing the labia minora and vagina to microtrauma that contributes to certain menopausal symptoms such as dryness, burning, pain and itching of the innermost structures.

This condition, named vulvo-vaginal atrophy, is still little known, although it affects 1 in 2 post-menopausal women.

There are several approaches for the treatment of this condition. A wide range of surgical techniques is available for reducing the labia minora, mostly based on marginal excision or resection of the protruding parts of the labia minora.

Augmentation of the labia majora, on the other hand, is a relatively new technique for which there is currently no standardised approach and there are not many studies on it.

Aesthetic medicine can improve the appearance not only of the face and body but also of the intimate parts.

Currently, hyaluronic acid fillers are widely used for skin rejuvenation, and vulvar fillers can be used for both aesthetic and functional purposes.

Hyaluronic acid is a natural substance that is fundamental to the tissues of all mammals and is mainly found in the deepest part of the skin.

Its biological function, in addition to its structural function, plays an important role in wound healing, skin renewal and modulation of the immune response.

Hyaluronic acid injection in dermaesthetics is widely used with success, as it is considered safe due to the substance's complete reabsorbability and excellent tolerability, and provides excellent three-dimensional volume restoration of the treated area. In addition, the treatment is carried out on an outpatient basis.

The product that is the subject of this clinical study, Vaginal Filler, is a class III medical device already on the market, whose gel formulation combines different types of high and low molecular weight hyaluronic acid, which provide better stability and consistency and ensure long duration and permanence in the site of interest.

Moreover, the derivation of hyaluronic acid from bacterial and non-animal fermentation guarantees a sterile and high-quality product, preventing possible allergic reactions.

Vaginal Filler is intended for the treatment of atrophy and volume enhancement of the female external genital areas (labia majora).

The aesthetic result is very natural and long-lasting (up to 8-12 months), depending on individual characteristics (skin type, individual metabolism, anatomy, age) and lifestyle.

The primary objective of the study is to evaluate the efficacy of Vaginal Filler, used according to the intended indications, in correcting atrophy of the female external genitalia (labia majora), with re-proportioning of the ratio between the labia minora and labia majora and improvement of sexual function.

The secondary objectives of the study are to assess:

1. the impact of Vaginal Filler used to improve sexual function;
2. the performance of Vaginal Filler in improving the participant's quality of life;
3. the performance of Vaginal F iller in reducing the demand for labiaplasty of the labia minora, in the absence of actual hypertrophy
4. the performance of Vaginal Filler used for vulvar remodelling;
5. the performance of Vaginal Filler in alleviating the symptoms of vulvar atrophy and hypotrophy;
6. the intensity of the participant's pain following Vaginal Filler injection;
7. the satisfaction of the participant following the use of Vaginal Filler;
8. the safety of use and tolerability of Vaginal Filler.

The study plans to include 76 female subjects aged 40-65 years, who are affected by atrophy and/or hypotrophy (mild to severe) of the labia majora.

This research will contribute to the collection of data and the acquisition of new knowledge regarding the efficacy, safety of use and tolerability of Vaginal Filler and its application in aesthetic and functional gynaecology.

Eligibility criteria: Inclusion Criteria:

* Subjects Informed consent form (ICF) signed;
* Female aged 40-65 years;
* Atrophy and/or hypotrophy of labra majora requiring volume augmentation. Hypotrophy will be preoperatively staged in mild, moderate and severe considering both the adipose tissue and the cutaneous layer;
* Body Mass Index (BMI)\<32 Kg/m2;
* Willingness to follow all study procedures, including attending all site visits, tests and examinations.

Exclusion Criteria:

* Allergy or controindications to device components;
* Allergy or controindications to anesthetic components;
* Previous surgery on external genitalia;
* Infectious or inflammatory processes close to the area of the procedure;
* History of vulvar cancer (including vulvar squamous papillomas) and/or previous regional radiotherapy;
* Active local herpes simplex or herpes zoster infection;
* Active herpes zoster infection in other sites;
* Active skin allergy including local dermatitis;
* Chronic pathological skin condition;
* Active mycosis and others bacterial infections;
* Immune system illnesses/disease;
* Known hypersensitivity to cheloids;
* Diabetes mellitus or uncontrolled systemic diseases (endocrine, hepatic renal, cardiac, pulmonary, neurological disorder);
* Problems with coagulation or anti-coagulating therapies in progress;
* Current treatment with substances which act on blood fluidity (eg. Aspirin, NSAIDs, Vitamin C), anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago), drugs able to influence the test results in the investigator opinion;
* Known drug and/or alcohol abuse;
* Mental incapacity that precludes adequate understanding or cooperation;
* Pregnancy or breastfeeding;
* COVID-19 vaccination within two month prior to study inclusion;
* Participation in another investigational study within 1 month prior to study inclusion.

Primary outcomes:
measure: Evaluation of the performance of Vaginal Filler in improving sexual functions.
timeFrame: At the end of the study (Visit V4) 6 months after enrolment.
Secondary outcomes:
measure: Evaluation of the performance of Vaginal Filler in improving sexual functions.
timeFrame: At V0 (Baseline visit day 0, before IP administration), V1 (2 weeks from V0), V2 (1 month from V0), V3 (3 months from V0) and V4 (6 months from V0).
measure: Evaluation of the performance of Vaginal Filler in improving subjects' quality of life.
timeFrame: At V0 (Baseline visit day 0), V1 (2 weeks from V0), V2 (1 month from V0), V3 (3 months from V0) and V4 (6 months from V0).
measure: Evaluation of the performance of Vaginal Filler in improving the shape and re-proportioning the ratio between labia minora and labia majora.
timeFrame: At V0 (Baseline visit day 0, before and after IP administration), V1 (2 weeks from V0), V2 (1 month from V0), V3 (3 months from V0) and V4 (6 months from V0).
measure: Evaluation of the performance of Vaginal Filler for vulvar reshaping.
timeFrame: At V0 (Baseline visit day 0, before and after IP administration), V1 (2 weeks from V0), V2 (1 month from V0), V3 (3 months from V0) and V4 (6 months from V0).
measure: Evaluation of the performance of Vaginal Filler to alleviate the symptoms of vulvar atrophy and hypotrophy.
timeFrame: At V0 (Baseline visit day 0), V1 (2 weeks from V0), V2 (1 month from V0), V3 (3 months from V0) and V4 (6 months from V0).
measure: Evaluation of pain intensity after injection of Vaginal Filler.
timeFrame: At V0 (Baseline visit day 0, after IP administration)
measure: Evaluation of patient tolerance and satisfaction with Vaginal Filler treatment.
timeFrame: At End-Of-Study visit (V4) (6 months after the treatment).
measure: Safety monitoring through vulva examination.
timeFrame: From V-1 (Screening visit Week -1) to V4 (End of Study) at 6 months.
measure: Assessment of device deficiency/incidents.
timeFrame: At baseline visit V0 and eventually at visit V2 (in case of touch-up one month after the first treatment).
measure: Collection of any adverse events and serious adverse events.
timeFrame: From baseline visit (V0) to the end of the study (V4) at 6 months.
measure: Assessment of concomitant medications.
timeFrame: From screening visit (V-1) to the end of the study (V4) at 6 months.
measure: Safety monitoring through vital signs by Blood Pressure.
timeFrame: From V-1 (Screening visit Week -1) to V4 (End of Study) at 6 months.
measure: Safety monitoring through vital signs by Heart Rate.
timeFrame: From V-1 (Screening visit Week -1) to V4 (End of Study) at 6 months.
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele di Milano
Study officials:
References: