Status:
COMPLETED
Treatment of Prepubertal Labial Adhesions
Lead Sponsor:
Children's Mercy Hospital Kansas City
Collaborating Sponsors:
University of Missouri, Kansas City
Conditions:
Prepubertal Labial Adhesions
Eligibility:
FEMALE
3-12 years
Phase:
NA
Brief Summary
First-line treatment for labial adhesions in prepubertal girls has been topical estrogen. This study aims to evaluate an alternative and less costly option of treatment with potentially less side effe...
Detailed Description
The etiology of labial adhesions is unclear but appears to be related to hypoestrogenism in combination with vulvar irritation. For many years, first-line treatment for labial adhesions in prepubertal...
Eligibility Criteria
Inclusion
- Prepubertal girls ages 3 months to 12 years with labial adhesions
Exclusion
- Presence of underlying dermatologic conditions such as lichen sclerosis, severe atopic dermatitis, psoriasis or vitiligo
- Presence of systemic conditions that can have vulvar manifestations such as Crohn's disease and Behçet disease
- Presence of disorders requiring immunosuppressant treatment
- Previous surgical separation of labial adhesions
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT02218463
Start Date
September 1 2014
End Date
June 1 2016
Last Update
April 23 2025
Active Locations (1)
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1
Children's Mercy Hospitals & Clinics
Kansas City, Missouri, United States, 64108