Clinical trial NCT02218463: Treatment of Prepubertal Labial Adhesions
Official title: Treatment of Prepubertal Labial Adhesions: A Prospective Comparison of Topical Emollient Versus Topical Estrogen.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prepubertal Labial Adhesions
Keywords: Vulvar disease, adhesions, topical therapy
Labial adhesions prepubertal girls
Labial agglutination
Labial fusion
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: University of Missouri, Kansas City
First posted: 2014-08-18
Enrollment: 43
Sex: FEMALE
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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: 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.

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

Primary outcomes:
measure: Complete Resolution of Labial Adhesion.
timeFrame: 3 weeks and 6 weeks
Secondary outcomes:
measure: Composite Severity Scale of Labial Adhesion Over Time
timeFrame: 3 weeks and 6 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospitals & Clinics
state: Missouri
Study officials:
affiliation: University of Missouri, Kansas City
name: Tazim Dowlut-McElroy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Missouri-Kansas City; Children's Mercy Hospital
name: Julie L Strickland, MD, MPH
role: STUDY_DIRECTOR
References: