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
• Status: Completed
• Phase: Phase 2/Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Sexual Function Disturbances
• Systemic Sclerosis
• Vulvovaginal Signs and Symptoms

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