Efficacy and Safety of BtH Intimate 2.0% (Injectable Cross-Linked Hyaluronic Acid) in the Volumization and Aesthetic Rejuvenation of the Female Vulvovaginal Area: A Prospective Clinical Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Global Aesthetic Improvement (GAIS)
研究概览
简要总结
This prospective, single-center, before-after study evalutated BtH Intimate 2.0%, a cross-linked hyaluronic acid injectable used to restore volume and improve the aesthetic appearance and hydration of the vulvovaginal area in adult women. Forty participants with mild to moderate vulvar atrophy or genital aging signs received a single treatment, with an optional touch-up at 4 weeks, and were followed for six months. The primary objectives were to measure global aesthetic improvement using the GAIS scale and to assess safety through the recording of serious adverse events. Secondary measures included patient satisfaction, sexual function (FSFI), symptom improvement (VAS), tissue hydration, and overall patient-reported benefit. Expected risks were mild and transient, consistent with HA fillers, while the intervention aimed to enhance comfort, appearance, and quality of life.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Adult women (≥18 years).
- •Women with mild or moderate vulvar atrophy, including deflation or vulvar ptosis, or with visible signs of genital aging, or women seeking aesthetic improvement of the vulvovaginal area, including peri-menopausal or women with genitourinary syndrome of menopause (GSM).
- •Ability and willingness to comply with all study visits and procedures.
- •Sufficient predisposition and capacity, in the investigator's judgment, to complete study questionnaires.
- •For women of childbearing potential: negative pregnancy test and agreement to use reliable contraception during the study (hormonal contraception, IUD/IUS, condoms, diaphragm with spermicide, vasectomized partner, or true abstinence).
排除标准
- •Allergy or hypersensitivity to any component of BtH Intimate 2.0%.
- •Pregnancy or planned pregnancy, or breastfeeding.
- •Active infection or pathology in the area to be treated.
- •Presence of bacterial, fungal, or viral infection in or near the vulvovaginal region, or current treatment for such conditions.
- •Known tendency to develop hypertrophic scars or keloids.
- •Signs of inflammation in or near the treatment area, or receiving treatment for inflammation.
- •History of any vulvovaginal rejuvenation procedure within the last 6 months or during the study (e.g., laser, radiofrequency, electrotherapy, dermal fillers, PRP, etc.).
- •Unrealistic or disproportionate expectations regarding treatment outcomes.
- •Incorrectly selected participants (those found retrospectively to fail inclusion or meet exclusion criteria) will be replaced.
研究组 & 干预措施
BtHIntimate® Injectable Hyaluronic Acid Treatment
Participants in this single-arm study will receive a single intradermal infiltration of BtH Intimate 2.0% intended to restore volume and improve the aesthetic appearance, hydration, and firmness of the vulvovaginal area.
干预措施: BtHIntimate® Injectable Hyaluronic Acid Treatment (Device)
结局指标
主要结局
Global Aesthetic Improvement (GAIS)
时间窗: Baseline to 12 weeks and 24 weeks
Aesthetic improvement of the vulvovaginal area assessed by the investigator using the 5-point Global Aesthetic Improvement Scale (GAIS: "very much improved," "much improved," "improved," "no change," "worse"). Clinical relevance is defined as ≥60% of participants rated as "Improved" or better at week 12 or 24.
Incidence of Serious Adverse Events (SAEs)
时间窗: 6 months
Number, frequency, severity, and relationship of all serious adverse events recorded according to EU MDR definitions (death, life-threatening events, hospitalization, permanent impairment, or fetal harm).
次要结局
- Usability Assessment (Investigator)(24 weeks)
- Patient Satisfaction (Likert Scale)(Immediatly post-treatment, at 4 weeks, at 12 weeks and at 24 weeks)
- Investigator-Rated Aesthetic Parameters with a Visual Analogue Scale (VAS)(Baseline, 4 weeks, 12 weeks, 24 weeks)
- Female Sexual Function Index (FSFI)(Baseline, 4 weeks, 12 weeks, 24 weeks)
- Vulvovaginal Symptoms (VAS)(Baseline, 4 weeks, 12 weeks, 24 weeks)
- PGI-I (Patient Global Impression of Improvement)(Time Frame: 4 weeks, 12 weeks, 24 weekS)
- Hydration of Vulvar Tissue (Corneometer®)(Baseline, 4 weeks, 12 weeks, 24 weeks)
- Non-Serious Adverse Events (AEs)(6 months)
- Future Use Questionnaire(24 weeks)