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Clinical trial

A Randomized, Unblinded Trial of Topical Steroids Plus CO2 Laser Compared to Steroids Alone in the Treatment of Vulvovaginal Lichen Sclerosus

ID
Name
1731682-3
Description
This study will compare the effects of fractionated CO2 laser plus topical steroids versus topical steroids alone in treatment of lichen sclerosus.
Trial arms
Trial start
2022-04-13
Estimated PCD
2025-04-13
Trial end
2025-04-13
Status
Recruiting
Phase
Early phase I
Treatment
MonaLisa Touch
3 laser treatments at 6 week intervals for 6 months by a single trained operator
Arms:
Fractionated CO2 laser plus topical steroids
Other names:
SMARTXIDE2
Topical steroid
self-applied topical steroid therapy using clobetasol propionate 0.05%
Arms:
Fractionated CO2 laser plus topical steroids, topical steroids alone
Other names:
clobetasol propionate
Size
52
Primary endpoint
Change in Skindex-29 score
Completed by the subject at baseline and 6 months.
Eligibility criteria
Inclusion Criteria: * women with biopsy proven lichen sclerosus and significant symptoms based on Skindex-29 scores \>21 Exclusion Criteria: * prior vaginal mesh or pelvic radiation * active genital infection * Current or past gynecologic malignancy
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 52, 'type': 'ESTIMATED'}}
Updated at
2023-12-07

1 organization

1 product

1 indication

Organization
University of South Alabama
Product
Topical steroid
Indication
Vulvar Lichen Sclerosus