Treatment of Prepubertal Labial Adhesions

Study Overview
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Brief Summary
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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.

Detailed Description
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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 girls has been topical estrogen. With the use of topical estrogen, 50% of labial adhesions resolve in 2 to 3 weeks and most labial adhesions resolve with 6 weeks of treatment. However, because topical estrogen is systemically absorbed, its use is associated with side effects such as breast budding, vulvar hyperpigmentation, vaginal bleeding. There is a high risk of recurrence of labial adhesions of up to 35% after treatment with topical estrogen. In addition, topical estrogen is costly. Therefore, there continues to be controversy over the optimal treatment of labial adhesions in prepubertal girls. Generally, for medical treatment of labial adhesions, topical estrogen is applied to the adhesion whist applying gentle lateral traction to promote separation of the labia. It is, therefore, plausible that the lateral traction applied to the adhesion site is what ultimately results in the separation of the labial fusion, while the use of estrogen improves healing after mechanical separation. This is a single site, prospective, randomized, double-blinded study evaluating the comparative effectiveness of topical estrogen with lateral traction versus topical emollient with lateral traction for the treatment of labial adhesions in prepubertal girls.

Official Title
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Treatment of Prepubertal Labial Adhesions: A Prospective Comparison of Topical Emollient Versus Topical Estrogen.

Conditions
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Prepubertal Labial Adhesions

Intervention / Treatment
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* Drug: Estradiol cream 0.01%
* Drug: Cetaphil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cetaphil<br>Apply a pea-sized amount to the labial adhesion with lateral traction twice daily | Drug: Cetaphil<br>* Apply a pea-sized amount to the labial adhesion with lateral traction twice daily<br>|
| Active Comparator: Estradiol Cream 0.01%<br>Apply a pea-sized amount to the labial adhesion with lateral traction twice daily | Drug: Estradiol cream 0.01%<br>* Apply a pea-sized amount to the labial adhesion with lateral traction twice daily<br>* Other names: Estrace Vaginal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Resolution of Labial Adhesion. | The first assessment will be 3 weeks after initiation of treatment. The final assessment will be 6 weeks after initiation of treatment. | 3 weeks and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Severity Scale of Labial Adhesion Over Time | Response to treatment of labial adhesion is dependent not only upon the size of the adhesion but also the thickness. A more accurate measurement of response to treatment would, therefore, incorporate both measurements. For this study, the percentage of closure of the introitus at presentation was assigned an ordinal value as follows: 1=25%, 2=50%, 3=75%, and 4=100%. The degree of thickness of the labial adhesion was also measured in a similar fashion: 1=thin, 2=intermediate and 3= thick. Those that were resolved received a rating of 0 on both scales. A composite severity scale was created by multiplying the value assigned to the percentage of introital closure by that assigned to the thickness of the adhesion for each of the 3 study visits. The composite severity scale ranged from 0 to 12. This allowed a comparison of treatment effect between each group over time wherein a lower composite severity score corresponded to a less severe labial adhesion. | 3 weeks and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vulvar disease, adhesions, topical therapy, Labial adhesions prepubertal girls, Labial agglutination, Labial fusion