A Multicentre, Open-Label, Interventional, Trial To Assess The Performance And Tolerance Of Janesse 20 In The Volume Restoration Of Labia Majora
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Global Aesthetic Improvement Scale (GAIS)
研究概览
简要总结
The use of hyaluronic acid (HA)-based fillers administered by injection to obtain Labia Majora augmentation is performed by many surgeons and gynaecologists in Europe, US and other countries, but few studies have investigated the effectiveness of this procedure. In this open not comparative study, 36 female subjects above or equal to 18 years old at inclusion, seeking genital rejuvenation, who have congenital or post-menopausal hypotrophy of the vulvar Labia Majora (or a diagnosis of Body Dysmorphic Disorder), who have given her informed consent and meet all the eligibility criteria, will be enrolled. Subjects will come to a total of 4 visits over a period of 2 months.
The primary objective of the study is to evaluate the performance of the dermal filler by the Global Aesthetic Improvement Scale (GAIS) at day 60 and the safety during all the study. The secondary objectives are the evaluation of volume restoration of Labia Majora (measured by caliper and Ultrasound) and the subjective evaluation (by Genital Appearance Satisfaction Scale) at different visits.
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
- 是
入选标准
- •Women with age ≥
- •Women seeking genital rejuvenation with Genital Appearance Satisfaction Scale (GAS) >20 and Cosmetic Procedure Screening Scale modified for Labia (COPS-L)>40 .
- •Patients with diagnosis of Body Dysmorphic Disorder (BDD) following DSM-IV criteria or congenital or post-menopausal Labia Majora hypotrophy
- •• The Labia Majora (left and right) width and/or length must be between the 5th and 95th percentiles as reported in the Annex 4 of the protocol (modified table from Kreklau A e t al 2018). The measurement must be performed by the Investigators using the Sliding Zuricher Caliper mm
- •Women willing to provide signed informed consent to clinical investigation participation.
排除标准
- •Use of aspirin and antiplatelet agents a week prior to treatment.
- •Pregnant or lactating women.
- •Women with history of allergy or hypersensitivity to the HA or to other ingredients of the dermal filler.
- •Women with history of allergy or hypersensitivity to Lidocaine, Mepivacaine or Prilocaine or local anaesthetics.
- •Women with any dermal systemic pathologies, such as systemic lupus erythematosus, psoriasis, scleroderma etc.
- •Women presenting bleeding disorders in the past or present.
- •Women taking or having indications for anticoagulant therapy.
- •Use of concomitant treatments or procedures aimed to improve genital skin rejuvenation over the last six months before the clinical investigation enrolment, such as chemical peeling, dermabrasion, laser resurfacing.
- •Women suffering from infectious diseases including herpes simplex virus infection, active hepatitis, Human Papilloma Virus (HPV) or Human Immunodeficiency Virus (HIV).
- •Women suffering from local dermatitis (vulvar scaly papilloma, mycosis, bacterial infection near the injection area).
- •Women at risk in term of precautions, warnings and contra-indications referred in the package insert of the clinical investigation device.
- •Women with autoimmune diseases, streptococcus disease.
- •Women with any active irritation or inflammation in the target areas of injection.
- •Recent vulvae surgery in the treatment area or progressive recent or nearby cancers (i.e. cervical cancer).
- •Tachycardia or other severe heart rhythm disorders
- •Women with previous regional radiotherapy.
- •Women who practice cycling or dedicate themselves to horse riding; women who practice bodybuilding or who perform professional sports.
- •Women unlikely to cooperate in the clinical investigation or to comply with the treatment or with the clinical investigation visits.
- •Performed dentist visit in the last week.
- •Women participating in another clinical investigation or treated with another HA filler with the same indications at the same time or within the preceding 30 days.
结局指标
主要结局
Global Aesthetic Improvement Scale (GAIS)
时间窗: 60 days
Global Aesthetic Improvement Scale (GAIS) is will be evaluated by the investigator using standardized photos. The scale is using scores as 1= VERY MUCH IMPROVED, 2= MUCH IMPROVED, 3 = IMPROVED, 4 = NO CHANGE, 5= WORSE. The picture will be done at 60 days after the initiation of treatment with Janesse 20, will be compared with Baseline Visit (day 0) and one of the above-mentioned scores will be gibed used to indicate the changes after the treatment.
Overall safety
时间窗: up to 60 days
The overall safety will be evaluated by safety checklist for the patient (modified from Liu S, 2010) and the searching of Adverse Event (s), Adverse Device Event (s), Serious Adverse Event (s), Serious Adverse Device Event (s), Unanticipated Serious Adverse Device Event (s) and Device Deficiency at each visit.
次要结局
- Dimensions of Labia Majora(30 days, 60 days)
- Genital Appearance Satisfaction (GAS)(30 days, 60 days)
- Global Aesthetic Improvement Scale (GAIS)(30 days, 60 days)