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Completed

NCT Number: NCT02218463

Treatment of Prepubertal Labial Adhesions

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.

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Key information

Conditions

Prepubertal Labial Adhesions Cicatrix Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Genital Diseases Genital Diseases, Female Pathologic Processes Pathological Conditions, Signs and Symptoms Tissue Adhesions Urogenital Diseases Vulvar Diseases

Age range

3 month–12 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Children's Mercy Hospitals & Clinics

Kansas City, Missouri, 64108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Estradiol cream 0.01%

Drug

Apply a pea-sized amount to the labial adhesion with lateral traction twice daily

Other names: Estrace Vaginal

Cetaphil

Drug

Apply a pea-sized amount to the labial adhesion with lateral traction twice daily

Primary outcomes

  1. Complete Resolution of Labial Adhesion.

    Time frame: 3 weeks and 6 weeks

    The first assessment will be 3 weeks after initiation of treatment. The final assessment will be 6 weeks after initiation of treatment.

Secondary outcomes

  1. Composite Severity Scale of Labial Adhesion Over Time

    Time frame: 3 weeks and 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Collaborators

  • University of Missouri, Kansas City

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 18, 2014
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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