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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women affected by Systemic Sclerosis and vulvovaginal atrophy | Experimental | CO2 vaginal laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CO2 Vaginal Laser | Device | CO2 Vaginal laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1-5 Likert Scale | Scale of satisfaction for the treatment | Six months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 0-10 Visual Analogue Scale | Scale of vulvovaginal symptoms severity | Six months follow up |
| Female Sexual Function Index | Questionnaire assessing sexual function |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele | Milan | 20132 | Italy |
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| Six months follow up |
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D020018 | Sexual Dysfunctions, Psychological |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D001523 | Mental Disorders |
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