N/A N=90 Randomized Double-blind Treatment

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

Atopic Dermatitis

Bottom Line

View on ClinicalTrials.gov: NCT01326910 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2012

Primary outcome: Primary: Eczema Area and Severity Index (EASI) — 3.014; 3.359; 1.286; 1.621 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Colloidal Oatmeal (Drug); Topical Cream (Device)
Age: Pediatric, Adult · 0+ yrs
Sex: All
Sponsor: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.
Primary completion: May 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Eczema Area and Severity Index (EASI)	3.014; 3.359; 1.286; 1.621; 1.310; 1.298	—
SECONDARY Interim Eczema Area and Severity Index (EASI)	38; 38; 3; 4	—
SECONDARY Assessment of Itch	1.557; 1.208; 1.840; 1.537; 2.199; 1.480	—
SECONDARY Investigator's Global Atopic Dermatitis Assessment (IGADA)	2.159; 2.182; 1.690; 1.667; 1.585; 1.548	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01326910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.