NCT06231433

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

January 22, 2024

Last Update Submit

January 22, 2024

Conditions

Systemic SclerosisVulvovaginal Signs and SymptomsSexual Function Disturbances

Outcome Measures

Primary Outcomes (1)

  • 1-5 Likert Scale

    Scale of satisfaction for the treatment

    Six months follow up

Secondary Outcomes (2)

  • 0-10 Visual Analogue Scale

    Six months follow up

  • Female Sexual Function Index

    Six months follow up

Study Arms (1)

Women affected by Systemic Sclerosis and vulvovaginal atrophy

EXPERIMENTAL

CO2 vaginal laser

Device: CO2 Vaginal Laser

Interventions

CO2 Vaginal LaserDEVICE

CO2 Vaginal laser

Women affected by Systemic Sclerosis and vulvovaginal atrophy

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Systemic Sclerosis; - vulvovaginal symptoms

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Scleroderma, SystemicSexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 22, 2024

First Posted

January 30, 2024

Study Start

May 1, 2020

Primary Completion

May 3, 2022

Study Completion

May 3, 2022

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)