Clinical trial NCT04652817: Evaluation of the Efficacy and Safety of the Dermal Filler for Augmentation of Labia Majora.
Official title: An Open-Label Uncontrolled Single Centre Study for the Evaluation of the Performance Characteristics (Efficacy and Safety) of the Dermal Filler MMI-22-04-2019 (Hyaluronic Acid 2,5%) for Female Intimate Area Augmentation of Labia Majora.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labia Majora Atrophy and Hypotrophy
Lead sponsor: Mesoestetic Pharma Group S.L.
Sponsor class: INDUSTRY
First posted: 2020-12-03
Enrollment: 35
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 "MMI-22-04-2019" on the female genital area for the aesthetic, medicinal, functional and reconstructive indications.

Detailed description: MMI-22-04-2019 is a dermal filler recommended for application in the intimate area. It is a sterile, injectable, colorless transparent gel, non-pyrogenic, reabsorbable medical device. Its main functional ingredient is cross-linked hyaluronic acid of non-animal origin, produced through bacterial fermentation.

The MMI-22-04-2019 is contained in pre-filled, graduated, disposable sterile syringe with Luer Lock adapter with 1 ml of net content. The sterilization of the product is achieved by moist heat.

The MMI-22-04-2019 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 vulvar ptosis, deflation or aesthetic discomfort in the intimate area;
* Subject who presents no type of pathology of the area to be treated;
* Subjects who are willing to abstain from any cosmetic or surgical procedures in the treatment area during the clinical investigation;
* Clinically and anamnestically healthy individual;
* Absence of a history of significant hypersensitivity to food and drugs or known sensitivity to hyaluronic acid;
* 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;
* Axillar body temperature of up to 370С;
* 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;
* 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 history of vulvar cancer and/or previous regional radiotherapy;
* Subjects with frequent or present active herpes simplex or herpes zoster local infection or active herpes simplex or herpes zoster infection in other sites;
* Subjects with history of frequent or active local dermatitis (of the injection site), vulvar scaly papilloma, mycosis; bacterial infection;
* Subjects suffering from autoimmune diseases or who are undergoing treatment with immunosuppressors or immunotherapy;
* Subjects uncontrolled systemic diseases;
* Pregnancy, postpartum period (6 months) or post-lactation period (6 months);
* Absence of a reliable and effective method of contraception;
* Subjects who are currently receiving another investigational treatment or who had participated in another clinical investigation within 30 days prior to study enrollment;
* Subjects who suffer from another medical condition or who are receiving medication that in the Principal Investigator's judgment would prohibit inclusion in the study;
* Subjects 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: Visual Analogous Scale (VAS) absolute change
timeFrame: From Day 0 (Session 1) to Day 60 (Session 3) - up to 8 weeks.
measure: Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: From screening through study completion, an average of 90 days - daily.
Secondary outcomes:
measure: Visual Analogous Scale (VAS)
timeFrame: From Day 0 (Session 1) to Day 0 (immediately after application), 30 (up to 4 weeks) and 90 (up to 12 weeks) (Session 1, 2 and 4).
measure: Global Aesthetic Improvement Scale (GAIS)
timeFrame: From Day 0 (immediately after application) to Days 30, 60 and 90 (up to 4 weeks, 8 weeks and 12 weeks respectively).
measure: Subject satisfaction
timeFrame: Days 0 (immediately after application), 30, 60 and 90 (up to 4 weeks, 8 weeks and 12 weeks respectively).
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Medical Centre Ramus
Study officials:
References: