NCT02218463

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
14 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

November 27, 2019

Completed
Last Updated

April 23, 2025

Status Verified

April 1, 2025

Enrollment Period

1.7 years

First QC Date

August 14, 2014

Results QC Date

January 30, 2017

Last Update Submit

April 21, 2025

Conditions

Prepubertal Labial Adhesions

Keywords

Vulvar disease, adhesions, topical therapyLabial adhesions prepubertal girlsLabial agglutinationLabial fusion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Composite Severity Scale of Labial Adhesion Over Time

    3 weeks and 6 weeks

Study Arms (2)

Cetaphil

ACTIVE COMPARATOR

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

Drug: Cetaphil

Estradiol Cream 0.01%

ACTIVE COMPARATOR

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

Drug: Estradiol cream 0.01%

Interventions

Estradiol cream 0.01%DRUG

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

Also known as: Estrace Vaginal
Estradiol Cream 0.01%
CetaphilDRUG

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

Cetaphil

Eligibility Criteria

Age3 Months - 12 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospitals & Clinics

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Vulvar DiseasesTissue Adhesions

Interventions

Estradiolcetyl alcohol, propylene glycol, sodium lauryl sulfate non-lipid cleansing lotion

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Dr. Tazim Dowlut-McElroy, M.D., M.S.
Organization
University of Missouri-Kansas City School of Medicine
tdowlut@cmh.edu
816-404-5150

Study Officials

  • Tazim Dowlut-McElroy, MD

    University of Missouri, Kansas City

    PRINCIPAL INVESTIGATOR

  • Julie L Strickland, MD, MPH

    University of Missouri-Kansas City; Children's Mercy Hospital

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2014

First Posted

August 18, 2014

Study Start

September 1, 2014

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

April 23, 2025

Results First Posted

November 27, 2019

Record last verified: 2025-04

Locations

US(1)