N/A N=43 Randomized Quadruple-blind Treatment

Treatment of Prepubertal Labial Adhesions

Prepubertal Labial Adhesions

Bottom Line

View on ClinicalTrials.gov: NCT02218463 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2019

Primary outcome: Primary: Complete Resolution of Labial Adhesion. — 21; 22 Participants — p=0.206

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Estradiol cream 0.01% (Drug); Cetaphil (Drug)
Age: Pediatric · 0+ yrs
Sex: Female
Sponsor: Children's Mercy Hospital Kansas City
Primary completion: May 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Complete Resolution of Labial Adhesion.	21; 22	0.206
SECONDARY Composite Severity Scale of Labial Adhesion Over Time	6.3; 6.2; 2.3; 1.5; 1.9; 1.6	0.0001 sig

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02218463). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.