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Treatment of Prepubertal Labial Adhesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02218463
Recruitment Status : Completed
First Posted : August 18, 2014
Results First Posted : November 27, 2019
Last Update Posted : November 27, 2019
Sponsor:
Collaborator:
University of Missouri, Kansas City
Information provided by (Responsible Party):
Tazim Dowlut-McElroy, Children's Mercy Hospital Kansas City

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.


Condition or disease Intervention/treatment Phase
Prepubertal Labial Adhesions Drug: Estradiol cream 0.01% Drug: Cetaphil Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Prepubertal Labial Adhesions: A Prospective Comparison of Topical Emollient Versus Topical Estrogen.
Study Start Date : September 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
Active Comparator: Cetaphil
Apply a pea-sized amount to the labial adhesion with lateral traction twice daily
Drug: Cetaphil
Apply a pea-sized amount to the labial adhesion with lateral traction twice daily

Active Comparator: Estradiol Cream 0.01%
Apply a pea-sized amount to the labial adhesion with lateral traction twice daily
Drug: Estradiol cream 0.01%
Apply a pea-sized amount to the labial adhesion with lateral traction twice daily
Other Name: Estrace Vaginal




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 12 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218463


Locations
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United States, Missouri
Children's Mercy Hospitals & Clinics
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
University of Missouri, Kansas City
Investigators
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Principal Investigator: Tazim Dowlut-McElroy, MD University of Missouri, Kansas City
Study Director: Julie L Strickland, MD, MPH University of Missouri-Kansas City; Children's Mercy Hospital
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Responsible Party: Tazim Dowlut-McElroy, Pediatric and Adolescent Gynecology Fellow, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT02218463    
Other Study ID Numbers: CMH14010039
First Posted: August 18, 2014    Key Record Dates
Results First Posted: November 27, 2019
Last Update Posted: November 27, 2019
Last Verified: November 2019
Keywords provided by Tazim Dowlut-McElroy, Children's Mercy Hospital Kansas City:
Vulvar disease, adhesions, topical therapy
Labial adhesions prepubertal girls
Labial agglutination
Labial fusion
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes
Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs