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OpenTrials
Completed

NCT Number: NCT06231433

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

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.

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Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Mental Disorders Scleroderma, Systemic Sexual Dysfunctions, Psychological Sexual Function Disturbances Skin Diseases Skin and Connective Tissue Diseases Vulvovaginal Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

IRCCS San Raffaele

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Systemic Sclerosis; - vulvovaginal symptoms

Exclusion criteria

  • gynecological neoplasia; - pregnancy; - pelvic organ prolapse; - vaginal and urinary infection; - pudendal neuropathy

Treatment and study plan

CO2 Vaginal Laser

Device

CO2 Vaginal laser

Primary outcomes

  1. 1-5 Likert Scale

    Time frame: Six months follow up

    Scale of satisfaction for the treatment

Secondary outcomes

  1. 0-10 Visual Analogue Scale

    Time frame: Six months follow up

    Scale of vulvovaginal symptoms severity

  2. Female Sexual Function Index

    Time frame: Six months follow up

    Questionnaire assessing sexual function

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Acronym: SCLERDERMCO2

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 30, 2024
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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