NCT02357940

Tolerance Evaluation of a Nighttime Moisturizing Balm on Babies and Adults With Eczema

Clinical Trial to Evaluate the Tolerance of a Nighttime Moisturizing Balm on Babies and Adults With Mild to Moderate Atopic Dermatitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI) · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

Summary

The purpose of this 14-day, two phase clinical study is to test the tolerance of a new over-the-counter moisturizing balm on subjects with eczema.

Detailed description

At least 60 subjects will be enrolled to ensure 40 (10 adults and 30 babies) completed subjects. The tolerability of this formulation will be monitored in a small group of ten adult subjects with mild to moderate eczema prior to testing in babies. In Group A, adults will be asked to give their informed consent and an evaluation of inclusion/exclusion criteria will be performed at the site. After screening, all subjects will be asked not to use any skin treatments until the next clinic visit. Subjects will use the investigational product as indicated at least twice per day on the face - cheeks only, arms, legs and torso for 14 days. For both adults and babies, only the baseline measurements are collected at 5-10 minutes after first application, but not at Day 1, Day 7 and Day 14 visits. Babies from 6 to 36 months of age with mild to moderate eczema, who meet the eligibility criteria, will follow a similar testing directions in Group B of the study.

Conditions

• Atopic Dermatitis (AD)

Interventions

Type	Name	Description
DRUG	Experimental Product	1% Colloidal Oatmeal Balm

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2015-02-06
• Last updated: 2017-01-10
• Results posted: 2016-11-15

Locations

2 sites across 1 country: United States