drugset / Trial / NCT02404493

Test to Determine the Effectiveness of Moisturizing Balm Used on Babies With Dry, Itchy Skin

NCT02404493 ↗

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this 3 week study is to test the effectiveness of an over-the-counter (OTC) skin balm in infants and toddlers with mild to moderate dry, itchy skin.

Timeline

Start
2015-03
Primary completion
2016-03
Completion
2016-03

Outcome

Met primary endpoint

Stopped (Enrollment): “Lack of subject enrollment and the eczema season has completed”

registry 1% Colloidal Oatmeal Balm vs EpiCeram Skin Barrier Emulsion; p = 0.003; Mean Difference (Final Values) 422.81 NCT02404493 ↗

registry 1% Colloidal Oatmeal Balm vs EpiCeram Skin Barrier Emulsion; p = 0.013; Median Difference (Final Values) 52.30 NCT02404493 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Colloidal Oatmeal Balm Other / unclassified — Topical

Indications