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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: From screening through study completion, an average of 90 days - daily.
Frequency and severity of adverse events (AEs) and adverse device effects.
Visual Analogous Scale (VAS) absolute change
时间窗: From Day 0 (Session 1) to Day 60 (Session 3) - up to 8 weeks.
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.
次要结局
- Visual Analogous Scale (VAS)(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).)
- Global Aesthetic Improvement Scale (GAIS)(From Day 0 (immediately after application) to Days 30, 60 and 90 (up to 4 weeks, 8 weeks and 12 weeks respectively).)
- Subject satisfaction(Days 0 (immediately after application), 30, 60 and 90 (up to 4 weeks, 8 weeks and 12 weeks respectively).)