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Human Testing of an Over-the-Counter (OTC) Cream in Children With Eczema

NCT ID: NCT01326910

Last Updated: 2012-08-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-06-30

Brief Summary

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This three week study will be conducted to determine the safety and efficacy of an over-the-counter (OTC) cream in children with mild to moderate atopic dermatitis.

Detailed Description

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The objective of this trial is to evaluate the efficacy and safety of an OTC colloidal oatmeal skin protectant cream in children with mild to moderate AD in comparison to that of EpiCeram®

Conditions

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Atopic Dermatitis

Keywords

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Eczema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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19306-127

Experimental Topical cream applied twice daily (or as needed)

Group Type EXPERIMENTAL

Colloidal Oatmeal

Intervention Type DRUG

Topical cream applied twice daily (or as needed)

19306-137

Marketed Topical cream applied twice daily (or as needed)

Group Type OTHER

Topical Cream

Intervention Type DEVICE

Topical cream applied twice daily (or as needed)

Interventions

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Colloidal Oatmeal

Topical cream applied twice daily (or as needed)

Intervention Type DRUG

Topical Cream

Topical cream applied twice daily (or as needed)

Intervention Type DEVICE

Other Intervention Names

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Not yet marketed EpiCeram

Eligibility Criteria

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Inclusion Criteria

* Children ages 6 mo- 18 years
* Any ethnicity
* Diagnosed with atopic dermatitis (AD) per Hanifin-Rajka criteria
* Mild to moderate atopic dermatitis per Rajka-Langeland severity index
* Willing to use only provided cream and body wash for duration of study

Exclusion Criteria

* Known sensitivity to investigational products
* Pregnant or breastfeeding
* Severe AD per Rajka-Langeland severity index
* AD requiring class I (super potent) or class II or III (potent) topical steroids
* Requires greater than 2.0 g inhaled or intranasal corticosteroids
* Other skin conditions which may interfere with the scoring of AD
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qing Li, MD, PhD

Role: STUDY_DIRECTOR

Johnson & Johnson Consumer and Personal Products Worldwide

Locations

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Hilltop Research

St. Petersburg, Florida, United States

Site Status

Hilltop Research

Miamiville, Ohio, United States

Site Status

Countries

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United States

References

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Lisante TA, Nunez C, Zhang P. Efficacy and safety of an over-the-counter 1% colloidal oatmeal cream in the management of mild to moderate atopic dermatitis in children: a double-blind, randomized, active-controlled study. J Dermatolog Treat. 2017 Nov;28(7):659-667. doi: 10.1080/09546634.2017.1303569. Epub 2017 Apr 2.

Reference Type DERIVED
PMID: 28366039 (View on PubMed)

Other Identifiers

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HTR 11-130435-111

Identifier Type: OTHER

Identifier Source: secondary_id

COOADM3002

Identifier Type: -

Identifier Source: org_study_id