NCT02404493

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

A Clinical Trial to Evaluate the Efficacy of an Investigational Nighttime Moisturizing Balm in the Management of Mild to Moderate Atopic Dermatitis in Infants and Toddlers

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI) · Industry
• Sex: All
• Age: 6 Months – 47 Months
• Healthy volunteers: Not accepted

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.

Detailed description

50 infants and toddlers will be enrolled in this study to yield 40 completed subjects, 30 babies in the active treatment group and 10 babies in the positive control group. Infants and toddlers aged 6 to 47 months inclusive will receive either a prescription or non-marketed investigational product for the treatment of eczema. Caregivers will be asked to stop use of prescription eczema treatments one week before the start of the study and during the study. Caregivers will apply study product to babies as indicated for 14 days to affected areas. Subject caregivers will record treatment use in a daily diary and complete questionnaires. A dermatologist will examine and score the babies eczema and symptoms. Skin moisture levels will also be tested.

Conditions

• Eczema

Interventions

Type	Name	Description
DEVICE	EpiCeram Skin Barrier Emulsion	EpiCeram Skin Barrier Emulsion
DRUG	1% Colloidal Oatmeal Balm	Experimental Product 1% Colloidal Oatmeal Balm

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-03-31
• Last updated: 2017-03-24
• Results posted: 2017-03-24

Locations

1 site across 1 country: United States