ClinicalTrials.gov
ClinicalTrials.gov Menu

To Evaluate the Safety and Efficacy of a New Device in the Management of Mild to Moderate Atopic Dermatitis in Children

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: NCT00886587
Recruitment Status : Completed
First Posted : April 23, 2009
Results First Posted : May 23, 2017
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Atopic Dermatitis
Interventions Device: F# 11054-010
Device: F# 10495-053
Enrollment 82
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Investigational Device Atopiclair® Skin and Wound Emulsion
Hide Arm/Group Description Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin. Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
Period Title: Overall Study
Started 41 41
Completed 37 39
Not Completed 4 2
Reason Not Completed
Adverse Event             2             1
Protocol Violation             2             0
Withdrawal by Subject             0             1
Arm/Group Title Investigational Device Atopiclair® Skin and Wound Emulsion Total
Hide Arm/Group Description Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin. Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin. Total of all reporting groups
Overall Number of Baseline Participants 41 41 82
Hide Baseline Analysis Population Description
All randomized subjects.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 41 participants 82 participants
6.37  (2.90) 5.56  (2.84) 5.96  (2.88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 41 participants 82 participants
Female
18
  43.9%
28
  68.3%
46
  56.1%
Male
23
  56.1%
13
  31.7%
36
  43.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants 41 participants 82 participants
41 41 82
1.Primary Outcome
Title Eczema Area and Severity Index (EASI) Score on Day 43 - Change From Baseline
Hide Description The surface and severity of eczema is measured using the 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 possible calculation ranging from 0 (none) - 72 (severe).
Time Frame Baseline to Day 43
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Investigational Device Atopiclair® Skin and Wound Emulsion
Hide Arm/Group Description:
Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
Overall Number of Participants Analyzed 39 40
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-4.97  (0.41) -5.01  (0.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational Device, Atopiclair® Skin and Wound Emulsion
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9416
Comments The significance threshold level was 0.05 (two-sided).
Method Repeated measures ANCOVA
Comments Treatment, visit number, and treatment-visit number interaction term as factors, with baseline score and age as covariates.
Method of Estimation Estimation Parameter Estimated Mean Difference
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-1.09 to 1.17
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Eczema Area and Severity Index (EASI) on Day 15 - Change From Baseline
Hide Description The surface and severity of eczema is measured using the 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 possible calculation ranging from 0 (none) - 72 (severe).
Time Frame Baseline to Day 15
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Investigational Device Atopiclair® Skin and Wound Emulsion
Hide Arm/Group Description:
Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
Overall Number of Participants Analyzed 35 41
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.79  (0.41) -4.14  (0.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational Device, Atopiclair® Skin and Wound Emulsion
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5431
Comments The significance level threshold level was 0.05 (two-sided).
Method Repeated measures ANCOVA
Comments Treatment, visit number, and treatment-visit number interaction term as factors, with baseline score and age as covariates.
Method of Estimation Estimation Parameter Estimated Mean Difference
Estimated Value 0.35
Confidence Interval (2-Sided) 95%
-0.78 to 1.48
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 43 - Change From Baseline
Hide Description The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA), with possible values of clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5).
Time Frame Baseline to Day 43
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Investigational Device Atopiclair® Skin and Wound Emulsion
Hide Arm/Group Description:
Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
Overall Number of Participants Analyzed 41 41
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.78  (0.15) 0.73  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational Device, Atopiclair® Skin and Wound Emulsion
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.788
Comments The significance threshold level was 0.05 (two-sided).
Method ANCOVA
Comments Treatment as a factor, baseline score as covariate.
Method of Estimation Estimation Parameter Estimated Mean Difference
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.47 to 0.36
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Itch Score on Day 43 - Change From Baseline
Hide Description The subject’s and/or caregiver's assessment of itch was measured on a 10-cm visual analog scale (VAS) in which 0 cm represented no itch and 10 cm represented worst itch imaginable.
Time Frame Baseline to Day 43
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the intent-to-treat subjects who had data available at the specified time point.
Arm/Group Title Investigational Device Atopiclair® Skin and Wound Emulsion
Hide Arm/Group Description:
Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
Overall Number of Participants Analyzed 37 36
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.26  (0.33) -3.29  (0.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational Device, Atopiclair® Skin and Wound Emulsion
Comments The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9508
Comments The significance threshold level was 0.05 (two-sided).
Method Repeated measures ANCOVA
Comments Treatment, visit number, and treatment-visit number interaction term as factors, with baseline score and age as covariates.
Method of Estimation Estimation Parameter Estimated Mean Difference
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.90 to 0.96
Estimation Comments [Not Specified]
Time Frame Day 43, +30 days for serious adverse events.
Adverse Event Reporting Description Adverse events were systematically collected at each study visit through Visit 8 (Day 43). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
 
Arm/Group Title Investigational Device Atopiclair® Skin and Wound Emulsion
Hide Arm/Group Description Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin. Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
All-Cause Mortality
Investigational Device Atopiclair® Skin and Wound Emulsion
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Investigational Device Atopiclair® Skin and Wound Emulsion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/41 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Investigational Device Atopiclair® Skin and Wound Emulsion
Affected / at Risk (%) Affected / at Risk (%)
Total   15/41 (36.59%)   12/41 (29.27%) 
General disorders     
Application Site Irritation  1  7/41 (17.07%)  11/41 (26.83%) 
Application Site Pain  1  9/41 (21.95%)  7/41 (17.07%) 
Infections and infestations     
Gastroenteritis  1  3/41 (7.32%)  1/41 (2.44%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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.
Investigators agreed not to publish the study results without prior sponsor approval.
Results Point of Contact
Name/Title: Amisha Parikh-Das, PhD/Study Director
Organization: Johnson & Johnson Consumer Inc
Phone: 973 385-2863 USA EST
Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00886587     History of Changes
Other Study ID Numbers: EMOECZ0002
First Submitted: April 22, 2009
First Posted: April 23, 2009
Results First Submitted: January 16, 2017
Results First Posted: May 23, 2017
Last Update Posted: May 23, 2017