Efficacy and Safety of CO₂ Laser Therapy Combined With Collagen Cream in Managing Vulvo-Vaginal Atrophy: A Randomized, Controlled Study on Symptom Relief and Microbiome Modulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in VVA (Vulvo-Vaginal Atrophy) symptoms
研究概览
简要总结
This study evaluated a new treatment for postmenopausal women suffering from vulvo-vaginal atrophy (VVA), a condition that causes dryness, burning, and pain. Researchers tested whether combining CO₂ laser therapy with a collagen-based cream could improve symptoms more effectively than laser treatment alone.
详细描述
Sixty women participated in the study. Results showed that the combination treatment provided greater relief from discomfort and helped restore vaginal health, with fewer side effects. This approach may offer a safe and effective alternative for women who cannot use hormone-based therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women with absence of menstrual cycle for at least 12 months, diagnosed with vulvovaginal atrophy (VVA) and presenting with related symptoms such as dryness, introital and deep dyspareunia, bleeding during intercourse, itching, or burning related to the severity of VVA, whether spontaneous or drug-induced (radio- or chemotherapy), either with a single symptom or a combination thereof.
- •Age between 35 and 75 years;
- •Patients unresponsive or dissatisfied with previous topical estrogen therapy, or presenting contraindications to the use of local and/or systemic estrogens.
- •Previous negative Pap test performed within 3 years prior to study enrollment.
排除标准
- •• Pregnancy or breastfeeding;
- •Presence of preneoplastic or neoplastic lesions of the cervix, vagina, or vulva;
- •Presence of active genital and/or urinary tract infection;
- •Relative or absolute dermatological contraindications to laser use;
- •Ongoing hormonal therapy (systemic or local);
- •Neurological and/or psychiatric disorders;
- •Chronic systemic autoimmune or metabolic diseases;
- •Refusal to provide informed consent.
研究组 & 干预措施
Laser Therapy Only (Control Group)
Participants receive fractional CO₂ laser therapy according to the standard protocol for vulvo-vaginal atrophy.
No additional topical treatment is applied.
Laser sessions are performed at baseline (Day 0), Day 30, and Day 60.
Follow-up visits include clinical evaluation and microbiome sampling at each time point.
干预措施: SmartXide2 treatment plus the application of Palingen cream (Device)
Laser Therapy Only (Control Group)
Participants receive fractional CO₂ laser therapy according to the standard protocol for vulvo-vaginal atrophy.
No additional topical treatment is applied.
Laser sessions are performed at baseline (Day 0), Day 30, and Day 60.
Follow-up visits include clinical evaluation and microbiome sampling at each time point.
干预措施: Laser Therapy Only (Control Group) (Device)
结局指标
主要结局
Improvement in VVA (Vulvo-Vaginal Atrophy) symptoms
时间窗: Outcome: Improvement in symptoms associated with vulvo-vaginal atrophy (VVA) Assessment Tool: Visual Analogue Scale (VAS) Time Frame: Baseline (Day 0) - before treatment Visit 1 (Day 30) - after first month of treatment Visit 2 (Day 60) - after second
Assessed after 30 and 60 days of treatment using the Visual Analogue Scale (VAS). The VAS was used to quantify symptom intensity such as burning, dryness, itching, dyspareunia, and pain. Improvement was measured as the difference in VAS scores before and after treatment.
次要结局
- Vaginal Microbiome Composition(Baseline (Day 0) - before treatment Visit 1 (Day 30) - after first month of treatment Visit 2 (Day 60) - after second month / end of treatment)
- Symptom improvement at intermediate time points(Baseline → Visit 1 (Day 30) Baseline → Visit 2 (Day 60))
- Adverse Events Monitoring(Continuous from first laser session (Day 0) through 30 days and 60 days post-treatment)
研究者
MAURIZIO FILIPPINI
Dott. Maurizio Filippini
Institute for Social Security, Republic of San Marino