Clinical trial NCT04659668: Evaluation of the Efficacy and Safety of the Dermal Filler for Female Intimate Area Hydration and Atrophy of the Vagina.
Official title: An Open-Label Uncontrolled Single Centre Study for the Evaluation of the Performance Characteristics (Efficacy and Safety) of the Dermal Filler MMG-23-04-2019 (Hyaluronic Acid 2,0%) for Female Intimate Area Hydration and Atrophy of the Vagina.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Atrophy
Vulvovaginal Signs and Symptoms
Dyspareunia
Urinary Incontinence
Lead sponsor: Mesoestetic Pharma Group S.L.
Sponsor class: INDUSTRY
First posted: 2020-12-09
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

Brief summary: The study is an open-label uncontrolled single-center study for the evaluation of the Performance characteristics (efficacy and safety) of the dermal filler "MMG-23-04-2019" on the female genital area for the medicinal, functional and reconstructive indications.

Detailed description: The Dermal Filler is recommended for the female intimate areas, especially the internal area of the vagina (vaginal vestibule, introitus, vaginal walls, clitoris, "G" spot) for the following indications: vaginal dryness or discomfort, vaginal atrophy.

The main functional ingredient is cross-linked hyaluronic acid of non-animal origin, produced through bacterial fermentation.

The MMG-23-04-2019 is contained in pre-filled, graduated and disposable sterile syringe with Luer Lock adapter with 1 ml of net content and 20 mg/ml hyaluronic acid.

The MMG-23-04-2019 has been classified as a Class III medical device under Annex IX of Directive MDD 93/42 EEC since it is a long-term, invasive and absorbable medical device.

Eligibility criteria: Inclusion Criteria:

* Female subject aged ≥18;
* Subject presenting vaginal atrophy, dryness, dyspareunia or discomfort in the intimate area;
* Subject who presents no other type of pathology of the area to be treated;
* Subject who is willing to abstain from any cosmetic or surgical procedures in the treatment area during the clinical investigation;
* Subject who is willing to participate in all study related activities and who is available for the duration of their participation in the investigation for follow-up;
* Absence of a history of significant hypersensitivity to food and drugs or known sensitivity to hyaluronic acid;
* Clinically and anamnestic healthy individual;
* Arterial blood pressure (BP) (after 5 min. at rest in the supine position) systolic 90 - 140 mmHg and diastolic 50 - 90 mmHg;
* Heart rate (HR) (after 5 min. at rest in the supine position) over 50 beats/min and less than 90 beats/min;
* Respiratory rate between 12 - 24 breaths/min;
* An axillar body temperature of up to 37 degrees celsius;
* Clinical-laboratory examinations within the reference ranges or with no clinically significant abnormalities;
* Negative AIDS/HIV test;
* Negative pregnancy test for the women with reproductive potential;
* A reliable and acceptable method of contraception for the women of child-bearing potential:
* Signed written Informed Consent Form

Exclusion Criteria:

* Subject with known sensitivity to hyaluronic acid or significant hypersensitivity to food and drugs;
* Subject with a history of vulvar cancer and/or previous regional radiotherapy;
* Subject with genital prolapse with a surgical indication or stress incontinence with a surgical indication;
* A subject who suffers from vaginism;
* Subject with genital bleeding of unknown origin;
* Subject with frequent or present active herpes simplex or herpes zoster local infection or active herpes simplex or herpes zoster infection in other sites;
* Subject with a history of frequent or active local dermatitis (of the injection site), vulvar scaly papilloma, mycosis; bacterial infection or laboratory tests indicating for such;
* A subject suffering from autoimmune diseases or who are undergoing treatment with immunosuppressors or immunotherapy;
* Subject with uncontrolled systemic diseases or who are undergoing current treatment with antihypertensives, steroid anti-inflammatory drugs anticoagulants, aspirin, major antidepressants;
* Pregnancy, postpartum period (6 months), lactation or post-lactation period (6 months);
* Absence of a reliable and effective method of contraception for a subject with childbearing potential;
* Subjects who are currently receiving another investigational treatment or who had participated in another clinical investigation within 30 days prior to study enrollment;
* A subject who suffer from another medical condition or who are receiving medication that in the Principal Investigator's judgment would prohibit the inclusion in the study;
* Subject with limited mental activity and consistent comprehension ability; sportsmen and individuals on strenuous physical loading; prisoners;
* Refusal to sign the Informed Consent Form.

Primary outcomes:
measure: Vaginal Maturation Index (VMI) absolute change
timeFrame: From baseline to Day 60 (up to 8 weeks).
measure: Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: From screening through study completion, an average of 60 days - daily.
Secondary outcomes:
measure: The change in the Gloria Bachmann Vaginal Health Index (VHI)
timeFrame: From baseline to Day 30 (4 weeks) and Day 60 (up to 8 weeks).
measure: The absolute change in Visual Analogous Scale (VAS).
timeFrame: From baseline to Day 30 (4 weeks) and Day 60 (up to 8 weeks).
measure: The absolute change in Visual Analogous Scale (VAS)
timeFrame: From Day 0 to Day 30 (4 weeks) and Day 60 (up to 8 weeks).
measure: The change of the Female Sexual Function Index (FSFI) score.
timeFrame: From Day 0 to Day 30 and Day 60 (up to 4 weeks and 8 weeks respectively).
measure: Subject satisfaction evaluated by the Global Impression of Improvement (PGI-I) questionnaire
timeFrame: From Day 30 (4 weeks) to Day 60 (up to 8 weeks).
measure: The change if the Nugent Score
timeFrame: From baseline to Day 60 (up to 8 weeks).
measure: Viganal biopsy (optional)
timeFrame: From Day 0 up to Day 60 (up to 8 weeks).
measure: Participant's Questionnaire
timeFrame: From Day 0 to Day 30 and Day 60 (up to week 4 and 8 respectively).
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Medical Centre Ramus
Study officials:
References: