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Tolerance Evaluation of a Nighttime Moisturizing Balm on Babies and Adults With Eczema

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ClinicalTrials.gov Identifier: NCT02357940
Recruitment Status : Completed
First Posted : February 6, 2015
Results First Posted : November 15, 2016
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Atopic Dermatitis (AD)
Intervention: Drug: Experimental Product

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Adults Adults - 1% Colloidal Oatmeal Balm
Babies Babies - 1% Colloidal Oatmeal Balm

Participant Flow:   Overall Study
    Adults   Babies
STARTED   9   32 
COMPLETED   9   30 
NOT COMPLETED   0   2 
Adverse Event                0                1 
Investigator's judgement                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Adults Adults - 1% Colloidal Oatmeal Balm
Babies Babies - 1% Colloidal Oatmeal Balm
Total Total of all reporting groups

Baseline Measures
   Adults   Babies   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   32   41 
Age 
[Units: Months]
Mean (Standard Deviation)
 400.0  (137.5)   22.8  (8.89)   105.6  (169.8) 
Gender 
[Units: Participants]
Count of Participants
     
Female      6  66.7%      13  40.6%      19  46.3% 
Male      3  33.3%      19  59.4%      22  53.7% 
Region of Enrollment 
[Units: Participants]
     
USA   9   32   41 


  Outcome Measures

1.  Primary:   Percentage With Erythema on the Face at Baseline Before Investigational Product Application   [ Time Frame: At baseline before investigational product application ]

2.  Primary:   Percentage With Erythema on the Arms at Baseline Before Investigational Product Application   [ Time Frame: At baseline before investigational product application ]

3.  Primary:   Percentage With Erythema on the Legs at Baseline Before Investigational Product Application   [ Time Frame: At baseline before investigational product application ]

4.  Primary:   Percentage With Erythema on the Torso at Baseline Before Investigational Product Application   [ Time Frame: At baseline before investigational product application ]

5.  Primary:   Percentage With Erythema on the Face at Baseline After Investigational Product Application   [ Time Frame: At baseline after investigational product application ]

6.  Primary:   Percentage With Erythema on the Arms at Baseline After Investigational Product Application   [ Time Frame: At baseline after investigational product application ]

7.  Primary:   Percentage With Erythema on the Legs at Baseline After Investigational Product Application   [ Time Frame: At baseline after investigational product application ]

8.  Primary:   Percentage With Erythema on the Torso at Baseline After Investigational Product Application   [ Time Frame: At baseline after investigational product application ]

9.  Primary:   Percentage With Erythema on the Face at Day 1   [ Time Frame: At Day 1 ]

10.  Primary:   Percentage With Erythema on the Arms at Day 1   [ Time Frame: At Day 1 ]

11.  Primary:   Percentage With Erythema on the Legs at Day 1   [ Time Frame: At Day 1 ]

12.  Primary:   Percentage With Erythema on the Torso at Day 1   [ Time Frame: At Day 1 ]

13.  Primary:   Percentage With Erythema on the Face at Day 7   [ Time Frame: At Day 7 ]

14.  Primary:   Percentage With Erythema on the Arms at Day 7   [ Time Frame: At Day 7 ]

15.  Primary:   Percentage With Erythema on the Legs at Day 7   [ Time Frame: At Day 7 ]

16.  Primary:   Percentage With Erythema on the Torso at Day 7   [ Time Frame: At Day 7 ]

17.  Primary:   Percentage With Erythema on the Face at Day 14   [ Time Frame: At Day 14 ]

18.  Primary:   Percentage With Erythema on the Arms at Day 14   [ Time Frame: At Day 14 ]

19.  Primary:   Percentage With Erythema on the Legs at Day 14   [ Time Frame: At Day 14 ]

20.  Primary:   Percentage With Erythema on the Torso at Day 14   [ Time Frame: At Day 14 ]

21.  Primary:   Percentage With Edema on the Face at Baseline Before Investigational Product Application   [ Time Frame: At baseline before investigational product application ]

22.  Primary:   Percentage With Edema on the Arms at Baseline Before Investigational Product Application   [ Time Frame: At baseline before investigational product application ]

23.  Primary:   Percentage With Edema on the Legs at Baseline Before Investigational Product Application   [ Time Frame: At baseline before investigational product application ]

24.  Primary:   Percentage With Edema on the Torso at Baseline Before Investigational Product Application   [ Time Frame: At baseline before investigational product application ]

25.  Primary:   Percentage With Edema on the Face at Baseline After Investigational Product Application   [ Time Frame: At baseline after investigational product application ]

26.  Primary:   Percentage With Edema on the Arms at Baseline After Investigational Product Application   [ Time Frame: At baseline after investigational product application ]

27.  Primary:   Percentage With Edema on the Legs at Baseline After Investigational Product Application   [ Time Frame: At baseline after investigational product application ]

28.  Primary:   Percentage With Edema on the Torso at Baseline After Investigational Product Application   [ Time Frame: At baseline after investigational product application ]

29.  Primary:   Percentage With Edema on the Face at Day 1   [ Time Frame: At Day 1 ]

30.  Primary:   Percentage With Edema on the Arms at Day 1   [ Time Frame: At Day 1 ]

31.  Primary:   Percentage With Edema on the Legs at Day 1   [ Time Frame: At Day 1 ]

32.  Primary:   Percentage With Edema on the Torso at Day 1   [ Time Frame: At Day 1 ]

33.  Primary:   Percentage With Edema on the Face at Day 7   [ Time Frame: At Day 7 ]

34.  Primary:   Percentage With Edema on the Arms at Day 7   [ Time Frame: At Day 7 ]

35.  Primary:   Percentage With Edema on the Legs at Day 7   [ Time Frame: At Day 7 ]

36.  Primary:   Percentage With Edema on the Torso at Day 7   [ Time Frame: At Day 7 ]

37.  Primary:   Percentage With Edema on the Face at Day 14   [ Time Frame: At Day 14 ]

38.  Primary:   Percentage With Edema on the Arms at Day 14   [ Time Frame: At Day 14 ]

39.  Primary:   Percentage With Edema on the Legs at Day 14   [ Time Frame: At Day 14 ]

40.  Primary:   Percentage With Edema on the Torso at Day 14   [ Time Frame: At Day 14 ]

41.  Primary:   Percentage With Scaling on the Face at Baseline Before Investigational Product Application   [ Time Frame: At baseline before investigational product application ]

42.  Primary:   Percentage With Scaling on the Arms at Baseline Before Investigational Product Application   [ Time Frame: At baseline before investigational product application ]

43.  Primary:   Percentage With Scaling on the Legs at Baseline Before Investigational Product Application   [ Time Frame: At baseline before investigational product application ]

44.  Primary:   Percentage With Scaling on the Torso at Baseline Before Investigational Product Application   [ Time Frame: At baseline before investigational product application ]

45.  Primary:   Percentage With Scaling on the Face at Baseline After Investigational Product Application   [ Time Frame: At baseline after investigational product application ]

46.  Primary:   Percentage With Scaling on the Arms at Baseline After Investigational Product Application   [ Time Frame: At baseline after investigational product application ]

47.  Primary:   Percentage With Scaling on the Legs at Baseline After Investigational Product Application   [ Time Frame: At baseline after investigational product application ]

48.  Primary:   Percentage With Scaling on the Torso at Baseline After Investigational Product Application   [ Time Frame: At baseline after investigational product application ]

49.  Primary:   Percentage With Scaling on the Face at Day 1   [ Time Frame: At Day 1 ]

50.  Primary:   Percentage With Scaling on the Arms at Day 1   [ Time Frame: At Day 1 ]

51.  Primary:   Percentage With Scaling on the Legs at Day 1   [ Time Frame: At Day 1 ]

52.  Primary:   Percentage With Scaling on the Torso at Day 1   [ Time Frame: At Day 1 ]

53.  Primary:   Percentage With Scaling on the Face at Day 7   [ Time Frame: At Day 7 ]

54.  Primary:   Percentage With Scaling on the Arms at Day 7   [ Time Frame: At Day 7 ]

55.  Primary:   Percentage With Scaling on the Legs at Day 7   [ Time Frame: At Day 7 ]

56.  Primary:   Percentage With Scaling on the Torso at Day 7   [ Time Frame: At Day 7 ]

57.  Primary:   Percentage With Scaling on the Face at Day 14   [ Time Frame: At Day 14 ]

58.  Primary:   Percentage With Scaling on the Arms at Day 14   [ Time Frame: At Day 14 ]

59.  Primary:   Percentage With Scaling on the Legs at Day 14   [ Time Frame: At Day 14 ]

60.  Primary:   Percentage With Scaling on the Torso at Day 14   [ Time Frame: At Day 14 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Amisha Parikh-Das, PhD/Study Director
Organization: Johnson & Johnson Consumer Inc.
phone: 973-255-8701 USA EST
e-mail: AParikh1@its.jnj.com



Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )
ClinicalTrials.gov Identifier: NCT02357940     History of Changes
Other Study ID Numbers: CO-140908134135-SBCT
First Submitted: February 3, 2015
First Posted: February 6, 2015
Results First Submitted: July 26, 2016
Results First Posted: November 15, 2016
Last Update Posted: January 10, 2017