Labia Majora Atrophy and Hypotrophy Clinical Trial
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.
| Verified date | December 2020 |
| Source | Mesoestetic Pharma Group S.L. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 35 |
| Est. completion date | August 26, 2020 |
| Est. primary completion date | July 12, 2020 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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 370?; - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Medical Centre Ramus | Sofia |
| Lead Sponsor | Collaborator |
|---|---|
| Mesoestetic Pharma Group S.L. |
Bulgaria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Visual Analogous Scale (VAS) absolute change | The absolute change in VAS, judged by the Principal Investigator. VAS ranged between 0 (least satisfied) and 10 (most satisfied) is used. The higher the score, the better the cosmetic appearance. | From Day 0 (Session 1) to Day 60 (Session 3) - up to 8 weeks. | |
| Primary | Treatment-Emergent Adverse Events [Safety and Tolerability] | Frequency and severity of adverse events (AEs) and adverse device effects. | From screening through study completion, an average of 90 days - daily. | |
| Secondary | Visual Analogous Scale (VAS) | The absolute change in VAS, judged by the Principal Investigator. VAS ranged between 0 (least satisfied) and 10 (most satisfied) is used. The higher the score, the better the cosmetic appearance. | 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). | |
| Secondary | Global Aesthetic Improvement Scale (GAIS) | The change in GAIS as evaluated by the PI based on the photographs of the treated area. A 5-point scale rating improvement in appearance compared to pre-treatment - 1 being exceptional improvement and 5 being worsened. | From Day 0 (immediately after application) to Days 30, 60 and 90 (up to 4 weeks, 8 weeks and 12 weeks respectively). | |
| Secondary | Subject satisfaction | Subject satisfaction based on Questionnaire, including visual analogue scale, ranged between 0 (least satisfied) and 10 (most satisfied) is used and questions about discomfort and satisfaction. | Days 0 (immediately after application), 30, 60 and 90 (up to 4 weeks, 8 weeks and 12 weeks respectively). |