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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Vaginal Maturation Index (VMI) absolute change
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 "MMG-23-04-2019" on the female genital area for the medicinal, functional and reconstructive indications.
详细描述
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.
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 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
排除标准
- •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.
研究组 & 干预措施
MMG-23-04-2019
MMG-23-04-2019 is composed by sodium hyaluronate at concentration of 2% (20 mg/ml) with 1,4-Butanediol diglycidyl ether (BDDE) acting as a cross-linking agent, in aqueous solution at physiological pH. The filler of 1ml is administered once or twice depending on the individual necessity.
干预措施: MMG-23-04-2019 (Device)
结局指标
主要结局
Vaginal Maturation Index (VMI) absolute change
时间窗: From baseline to Day 60 (up to 8 weeks).
Improvement in the properties of the vaginal wall, measured by the VMI.
Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: From screening through study completion, an average of 60 days - daily.
Frequency and severity of adverse events (AEs) and adverse device effect
次要结局
- The change in the Gloria Bachmann Vaginal Health Index (VHI)(From baseline to Day 30 (4 weeks) and Day 60 (up to 8 weeks).)
- The absolute change in Visual Analogous Scale (VAS).(From baseline to Day 30 (4 weeks) and Day 60 (up to 8 weeks).)
- The absolute change in Visual Analogous Scale (VAS)(From Day 0 to Day 30 (4 weeks) and Day 60 (up to 8 weeks).)
- The change of the Female Sexual Function Index (FSFI) score.(From Day 0 to Day 30 and Day 60 (up to 4 weeks and 8 weeks respectively).)
- The change if the Nugent Score(From baseline to Day 60 (up to 8 weeks).)
- Subject satisfaction evaluated by the Global Impression of Improvement (PGI-I) questionnaire(From Day 30 (4 weeks) to Day 60 (up to 8 weeks).)
- Viganal biopsy (optional)(From Day 0 up to Day 60 (up to 8 weeks).)
- Participant's Questionnaire(From Day 0 to Day 30 and Day 60 (up to week 4 and 8 respectively).)