NCT01326910

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 3, 2012

Completed
Last Updated

August 3, 2012

Status Verified

June 1, 2012

Enrollment Period

2 months

First QC Date

March 30, 2011

Results QC Date

June 27, 2012

Last Update Submit

June 27, 2012

Conditions

Atopic Dermatitis

Keywords

Eczema

Outcome Measures

Primary Outcomes (1)

  • Eczema Area and Severity Index (EASI)

    A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72

    3 weeks

Secondary Outcomes (3)

  • Interim Eczema Area and Severity Index (EASI)

    Week 2

  • Assessment of Itch

    through Week 3

  • Investigator's Global Atopic Dermatitis Assessment (IGADA)

    through Week 3

Study Arms (2)

19306-127

EXPERIMENTAL

Experimental Topical cream applied twice daily (or as needed)

Drug: Colloidal Oatmeal

19306-137

OTHER

Marketed Topical cream applied twice daily (or as needed)

Device: Topical Cream

Interventions

Colloidal OatmealDRUG

Topical cream applied twice daily (or as needed)

Also known as: Not yet marketed
19306-127
Topical CreamDEVICE

Topical cream applied twice daily (or as needed)

Also known as: EpiCeram
19306-137

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hilltop Research

St. Petersburg, Florida, 33710, United States

Location

Hilltop Research

Miamiville, Ohio, 45147, United States

Location

Related Publications (1)

  • 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.

    PMID: 28366039DERIVED

MeSH Terms

Conditions

Dermatitis, AtopicEczema

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Joyce Hauze, Sr. Specialist Clinical Quality Systems and Process
Organization
Johnson & Johnson Consumer and Personal Products Worldwide
jhauze@its.jnj.com
928-277-0715

Study Officials

  • Qing Li, MD, PhD

    Johnson & Johnson Consumer and Personal Products Worldwide

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2011

First Posted

March 31, 2011

Study Start

March 1, 2011

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

August 3, 2012

Results First Posted

August 3, 2012

Record last verified: 2012-06

Locations

US(2)