Effects of Fractional CO2 Laser Treatment on Vaginal Symptoms and Sexual Dysfunction in Women With Systemic Sclerosis (SCLERDERMCO2)

S

San Donato Group (GSD)

Status and phase

Completed
Phase 3
Phase 2

Conditions

Vulvovaginal Signs and Symptoms
Systemic Sclerosis
Sexual Function Disturbances

Treatments

Device: CO2 Vaginal Laser

Study type

Interventional

Funder types

Other

Identifiers

NCT06231433
SCLERODERMCO2

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of Systemic Sclerosis; - vulvovaginal symptoms

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

16 participants in 1 patient group

Women affected by Systemic Sclerosis and vulvovaginal atrophy
Experimental group
Description:
CO2 vaginal laser
Treatment:
Device: CO2 Vaginal Laser

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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