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临床试验/NCT02218463
NCT02218463已完成不适用

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

Children's Mercy Hospital Kansas City1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
试验地点
1
主要终点
Complete Resolution of Labial Adhesion.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
3 Months 至 12 Years(Child)
性别
Female
接受健康志愿者

入选标准

  • Prepubertal girls ages 3 months to 12 years with labial adhesions

排除标准

  • 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

研究组 & 干预措施

Cetaphil

Active Comparator

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

干预措施: Cetaphil (Drug)

Estradiol Cream 0.01%

Active Comparator

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

干预措施: Estradiol cream 0.01% (Drug)

结局指标

主要结局

Complete Resolution of Labial Adhesion.

时间窗: 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.

次要结局

  • Composite Severity Scale of Labial Adhesion Over Time(3 weeks and 6 weeks)

研究者

发起方
Children's Mercy Hospital Kansas City
申办方类型
Other
责任方
Sponsor

研究点 (1)

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