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A Test to Determine the Usefulness and Safety of a Cream Used on Babies With Dry Itchy Skin

NCT02120833 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2017-01-13

Study results available
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Summary

This study is for infants with mild to moderate dry and itchy skin. This study will involve going to the doctor for 6 visits over 2 weeks. All participants' skin will be examined by a dermatologist to determine if they have atopic dermatitis and have an active mild to moderate eczema wound. Participant's parents/guardians will be asked a few questions to determine if their child qualifies for the study.

Then all participants' caregivers will complete a questionnaire at the beginning of the study. The child's skin will be examined to rate the level of their eczema and a trained examiner will grade the looks and symptoms of their eczema. All parents or guardians will be instructed how to apply the test product and how to record usage on a diary card and then apply the test product. The test product will be applied at least 2 times per day or more as needed on all body areas, including the face affected throughout the study.

One digital picture will be taken of one eczema wound. Another digital picture will be taken of the area around this wound. These pictures will be taken on Day 0 (Baseline), Day 3, and Day 14.

Once product is applied the skin will be examined for any adverse events and all participants' caregivers will complete a questionnaire on study day 1, 3, 7 and 14.

Conditions

Interventions

DEVICE

EpiCeram® Skin Barrier Emulsion

Device (including sham) Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin as directed.

DRUG

Colloidal Oatmeal Cream

Drug (including placebo) Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin as directed.

Sponsors & Collaborators

  • Johnson & Johnson Consumer and Personal Products Worldwide

    lead INDUSTRY

Principal Investigators

  • Christopher Nunez · Johnson & Johnson Consumer and Personal Products Worldwide

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02120833 on ClinicalTrials.gov