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NCT06231433 Clinical Trial

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

Systemic Sclerosis Clinical Trial

— SCLERDERMCO2  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06231433
Other study ID # SCLERODERMCO2
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date May 1, 2020
Est. completion date May 3, 2022

Study information
Verified date January 2024
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date May 3, 2022
Est. primary completion date May 3, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of Systemic Sclerosis; - vulvovaginal symptoms Exclusion Criteria: - gynecological neoplasia; - pregnancy; - pelvic organ prolapse; - vaginal and urinary infection; - pudendal neuropathy

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CO2 Vaginal Laser
CO2 Vaginal laser

Locations
Country Name City State
Italy IRCCS San Raffaele Milan

Sponsors (1)
Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 1-5 Likert Scale Scale of satisfaction for the treatment Six months follow up
Secondary 0-10 Visual Analogue Scale Scale of vulvovaginal symptoms severity Six months follow up
Secondary Female Sexual Function Index Questionnaire assessing sexual function Six months follow up
See also
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