A Phase 2/3 interventional study of CO2 Vaginal Laser in Systemic Sclerosis, Vulvovaginal Signs and Symptoms and Sexual Function Disturbances, sponsored by IRCCS San Raffaele. Completed at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by IRCCS San Raffaele · Phase 2/3, Interventional, and Treatment
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.
688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.
This study's enrollment of 16 is below the median of 34 across 493 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.
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Exclusion Criteria:
CO2 vaginal laser
Device: CO2 Vaginal Laser
CO2 Vaginal laser
1-5 Likert Scale
Scale of satisfaction for the treatment
Time frame: Six months follow up
0-10 Visual Analogue Scale
Scale of vulvovaginal symptoms severity
Time frame: Six months follow up
Female Sexual Function Index
Questionnaire assessing sexual function
Time frame: Six months follow up
Plan to share: No
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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IRCCS San Raffaele