Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01326910
Recruitment Status : Completed
First Posted : March 31, 2011
Results First Posted : August 3, 2012
Last Update Posted : August 3, 2012
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Interventions Drug: Colloidal Oatmeal
Device: Topical Cream
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 19306-127 19306-137
Hide Arm/Group Description Experimental Topical cream applied twice daily (or as needed) Marketed Topical cream applied twice daily (or as needed)
Period Title: Overall Study
Started 45 45
Completed 41 42
Not Completed 4 3
Reason Not Completed
Withdrawal by Subject             3             2
Protocol Violation             1             1
Arm/Group Title 19306-127 19306-137 Total
Hide Arm/Group Description Experimental Topical cream applied twice daily (or as needed) Marketed Topical cream applied twice daily (or as needed) Total of all reporting groups
Overall Number of Baseline Participants 45 45 90
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 45 participants 90 participants
6.9  (3.26) 9.3  (4.26) 8.1  (3.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 90 participants
Female
23
  51.1%
26
  57.8%
49
  54.4%
Male
22
  48.9%
19
  42.2%
41
  45.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants 45 participants 90 participants
45 45 90
1.Primary Outcome
Title Eczema Area and Severity Index (EASI)
Hide Description 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
Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT)
Arm/Group Title 19306-127 19306-137
Hide Arm/Group Description:
Experimental Topical cream applied twice daily (or as needed)
Marketed Topical cream applied twice daily (or as needed)
Overall Number of Participants Analyzed 45 45
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 0, Baseline 3.014  (1.9473) 3.359  (3.6925)
Day 7, Week 1 1.286  (1.0137) 1.621  (1.9275)
Day 14, Week 2 1.310  (2.0153) 1.298  (1.5811)
Day 21, Week 3 1.154  (1.1570) 1.064  (1.1320)
2.Secondary Outcome
Title Interim Eczema Area and Severity Index (EASI)
Hide Description Number of subjects improved at Week 2 compared to Baseline in EASI. Improved is defined as post baseline EASI score smaller than baseline score.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat
Arm/Group Title 19306-127 19306-137
Hide Arm/Group Description:
Experimental Topical cream applied twice daily (or as needed)
Marketed Topical cream applied twice daily (or as needed)
Overall Number of Participants Analyzed 41 42
Measure Type: Number
Unit of Measure: participants
Improved 38 38
Not Improved 3 4
3.Secondary Outcome
Title Assessment of Itch
Hide Description Subject’s or caregiver’s assessment of itch, on a 10-cm Visual Analogue Scale (VAS), where 0-no itch, 10-worst itch imaginable
Time Frame through Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT)
Arm/Group Title 19306-127 19306-137
Hide Arm/Group Description:
Experimental Topical cream applied twice daily (or as needed)
Marketed Topical cream applied twice daily (or as needed)
Overall Number of Participants Analyzed 45 45
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 0, Baseline 1.557  (2.2526) 1.208  (2.4939)
Day 7, Week 1 1.840  (2.2876) 1.537  (2.2051)
Day 14, Week 2 2.199  (2.4595) 1.480  (2.1464)
Day 21, Week 3 1.972  (2.7890) 1.685  (2.5902)
4.Secondary Outcome
Title Investigator's Global Atopic Dermatitis Assessment (IGADA)
Hide Description An assessment of Atopic Dermatitis based on a 4 point scale where 0 (none) and 3 (severe) are used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating will be 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe, or 5-very severe.
Time Frame through Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT)
Arm/Group Title 19306-127 19306-137
Hide Arm/Group Description:
Experimental Topical cream applied twice daily (or as needed)
Marketed Topical cream applied twice daily (or as needed)
Overall Number of Participants Analyzed 45 45
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 0, Baseline 2.159  (0.6078) 2.182  (0.6567)
Day 7, Week 1 1.690  (0.6803) 1.667  (0.7861)
Day 14, Week 2 1.585  (0.7062) 1.548  (0.8025)
Day 21, Week 3 1.585  (0.8055) 1.381  (0.7949)
Time Frame Three Weeks plus 30 days for Serious Adverse Events
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 19306-127 19306-137
Hide Arm/Group Description Experimental Topical cream applied twice daily (or as needed) Marketed Topical cream applied twice daily (or as needed)
All-Cause Mortality
19306-127 19306-137
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
19306-127 19306-137
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/45 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
19306-127 19306-137
Affected / at Risk (%) Affected / at Risk (%)
Total   6/45 (13.33%)   2/45 (4.44%) 
General disorders     
PYREXIA  1  2/45 (4.44%)  0/45 (0.00%) 
Immune system disorders     
SEASONAL ALLERGY  1  1/45 (2.22%)  0/45 (0.00%) 
Infections and infestations     
EAR INFECTION  1  0/45 (0.00%)  1/45 (2.22%) 
Skin and subcutaneous tissue disorders     
PRURITUS  1  2/45 (4.44%)  1/45 (2.22%) 
RASH PRURITIC  1  1/45 (2.22%)  0/45 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The trial was conducted as work made for hire, and disclosure of results by the investigator is prohibited without the prior written consent of Sponsor.
Results Point of Contact
Name/Title: Joyce Hauze, Sr. Specialist Clinical Quality Systems and Process
Organization: Johnson & Johnson Consumer and Personal Products Worldwide
Phone: 928-277-0715
Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. )
ClinicalTrials.gov Identifier: NCT01326910     History of Changes
Other Study ID Numbers: COOADM3002
HTR 11-130435-111 ( Other Identifier: CRO )
First Submitted: March 30, 2011
First Posted: March 31, 2011
Results First Submitted: June 27, 2012
Results First Posted: August 3, 2012
Last Update Posted: August 3, 2012