NCT06231433

Effects of Fractional CO2 Laser Treatment on Vaginal Symptoms and Sexual Dysfunction in Women With Systemic Sclerosis

Effect of Factional CO2 Laser Treatment on Vaginal Symptoms and Sexual Dysfunction in Women With Systemic Sclerosis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Women affected by Systemic Sclerosis and Vulvovaginal Atrophy will be submitted to a cycle composed of five vaginal CO2 laser treatment (SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy - Hi Scan V2LR con sonda vaginale a 360 °, dot power 30 watt, dwell time 1000 μs, dot spacing 1000 μm smart stack 1-3, emission mode deka pulse) every 30-40 days. At 1-month follow up from the last vaginal laser treatment (6 months from baseline) vagina and sexual health will be assessed by a 1-5 Likert scale, a 0-10 Visual Analogue Scale for vulvovaginal symptoms and the Female Sexual Function Index.

Conditions

• Systemic Sclerosis
• Vulvovaginal Signs and Symptoms
• Sexual Function Disturbances

Interventions

Type	Name	Description
DEVICE	CO2 Vaginal Laser	CO2 Vaginal laser

Timeline

• Start date: 2020-05-01
• Primary completion: 2022-05-03
• Completion: 2022-05-03
• First posted: 2024-01-30
• Last updated: 2024-01-30

Locations

1 site across 1 country: Italy