N/A
Completed N=43
Treatment of Prepubertal Labial Adhesions
Prepubertal Labial Adhesions
Source: ClinicalTrials.gov NCT02218463 ↗
Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Complete Resolution of Labial Adhesion. — 21; 22 Participants — p=0.206
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 effects.
Primary Hypothesis:
There will be a difference in complete resolution of labial adhesions with topical estrogen with lateral traction as compared to an emollient with lateral traction.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Resolution of Labial Adhesion. |
21; 22 | 0.206 |
| SECONDARY Composite Severity Scale of Labial Adhesion Over Time |
6.3; 6.2; 2.3; 1.5; 1.9; 1.6 | 0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Prepubertal girls ages 3 months to 12 years with labial adhesions
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02218463). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.