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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) )

Brief Summary:
The purpose of this 14-day, two phase clinical study is to test the tolerance of a new over-the-counter moisturizing balm on subjects with eczema.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis (AD) Drug: Experimental Product Not Applicable

Detailed Description:
At least 60 subjects will be enrolled to ensure 40 (10 adults and 30 babies) completed subjects. The tolerability of this formulation will be monitored in a small group of ten adult subjects with mild to moderate eczema prior to testing in babies. In Group A, adults will be asked to give their informed consent and an evaluation of inclusion/exclusion criteria will be performed at the site. After screening, all subjects will be asked not to use any skin treatments until the next clinic visit. Subjects will use the investigational product as indicated at least twice per day on the face - cheeks only, arms, legs and torso for 14 days. For both adults and babies, only the baseline measurements are collected at 5-10 minutes after first application, but not at Day 1, Day 7 and Day 14 visits. Babies from 6 to 36 months of age with mild to moderate eczema, who meet the eligibility criteria, will follow a similar testing directions in Group B of the study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial to Evaluate the Tolerance of a Nighttime Moisturizing Balm on Babies and Adults With Mild to Moderate Atopic Dermatitis
Study Start Date : January 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Adult Tolerance Assessment
Apply thin layer of experimental product to the affected skin areas at least 2 times per day and massage gently into skin
Drug: Experimental Product
1% Colloidal Oatmeal Balm
Other Name: Eczema Moisturizing Balm

Experimental: Baby (infants, toddlers, young children) Tolerance Assessment
Apply thin layer of experimental product to the affected skin areas at least 2 times per day and massage gently into skin
Drug: Experimental Product
1% Colloidal Oatmeal Balm
Other Name: Eczema Moisturizing Balm




Primary Outcome Measures :
  1. Percentage With Erythema on the Face at Baseline Before Investigational Product Application [ Time Frame: At baseline before investigational product application ]
    Percentage of adults and babies with erythema on the face at baseline before investigational product application

  2. Percentage With Erythema on the Arms at Baseline Before Investigational Product Application [ Time Frame: At baseline before investigational product application ]
    Percentage of adults and babies with erythema on the arms at baseline before investigational product application

  3. Percentage With Erythema on the Legs at Baseline Before Investigational Product Application [ Time Frame: At baseline before investigational product application ]
    Percentage of adults and babies with erythema on the legs at baseline before investigational product application

  4. Percentage With Erythema on the Torso at Baseline Before Investigational Product Application [ Time Frame: At baseline before investigational product application ]
    Percentage of adults and babies with erythema on the torso at baseline before investigational product application

  5. Percentage With Erythema on the Face at Baseline After Investigational Product Application [ Time Frame: At baseline after investigational product application ]
    Percentage of adults and babies with erythema on the face at baseline after investigational product application

  6. Percentage With Erythema on the Arms at Baseline After Investigational Product Application [ Time Frame: At baseline after investigational product application ]
    Percentage of adults and babies with erythema on the arms at baseline after investigational product application

  7. Percentage With Erythema on the Legs at Baseline After Investigational Product Application [ Time Frame: At baseline after investigational product application ]
    Percentage of adults and babies with erythema on the legs at baseline after investigational product application

  8. Percentage With Erythema on the Torso at Baseline After Investigational Product Application [ Time Frame: At baseline after investigational product application ]
    Percentage of adults and babies with erythema on the torso at baseline after investigational product application

  9. Percentage With Erythema on the Face at Day 1 [ Time Frame: At Day 1 ]
    Percentage of adults and babies with erythema on the face at Day 1

  10. Percentage With Erythema on the Arms at Day 1 [ Time Frame: At Day 1 ]
    Percentage of adults and babies with erythema on the arms at Day 1

  11. Percentage With Erythema on the Legs at Day 1 [ Time Frame: At Day 1 ]
    Percentage of adults and babies with erythema on the legs at Day 1

  12. Percentage With Erythema on the Torso at Day 1 [ Time Frame: At Day 1 ]
    Percentage of adults and babies with erythema on the torso at Day 1

  13. Percentage With Erythema on the Face at Day 7 [ Time Frame: At Day 7 ]
    Percentage of adults and babies with erythema on the face at Day 7

  14. Percentage With Erythema on the Arms at Day 7 [ Time Frame: At Day 7 ]
    Percentage of adults and babies with erythema on the arms at Day 7

  15. Percentage With Erythema on the Legs at Day 7 [ Time Frame: At Day 7 ]
    Percentage of adults and babies with erythema on the legs at Day 7

  16. Percentage With Erythema on the Torso at Day 7 [ Time Frame: At Day 7 ]
    Percentage of adults and babies with erythema on the torso at Day 7

  17. Percentage With Erythema on the Face at Day 14 [ Time Frame: At Day 14 ]
    Percentage of adults and babies with erythema on the face at Day 14

  18. Percentage With Erythema on the Arms at Day 14 [ Time Frame: At Day 14 ]
    Percentage of adults and babies with erythema on the arms at Day 14

  19. Percentage With Erythema on the Legs at Day 14 [ Time Frame: At Day 14 ]
    Percentage of adults and babies with erythema on the legs at Day 14

  20. Percentage With Erythema on the Torso at Day 14 [ Time Frame: At Day 14 ]
    Percentage of adults and babies with erythema on the torso at Day 14

  21. Percentage With Edema on the Face at Baseline Before Investigational Product Application [ Time Frame: At baseline before investigational product application ]
    Percentage of adults and babies with edema on the face at baseline before investigational product application

  22. Percentage With Edema on the Arms at Baseline Before Investigational Product Application [ Time Frame: At baseline before investigational product application ]
    Percentage of adults and babies with edema on the arms at baseline before investigational product application

  23. Percentage With Edema on the Legs at Baseline Before Investigational Product Application [ Time Frame: At baseline before investigational product application ]
    Percentage of adults and babies with edema on the legs at baseline before investigational product application

  24. Percentage With Edema on the Torso at Baseline Before Investigational Product Application [ Time Frame: At baseline before investigational product application ]
    Percentage of adults and babies with edema on the torso at baseline before investigational product application

  25. Percentage With Edema on the Face at Baseline After Investigational Product Application [ Time Frame: At baseline after investigational product application ]
    Percentage of adults and babies with edema on the face at baseline after investigational product application

  26. Percentage With Edema on the Arms at Baseline After Investigational Product Application [ Time Frame: At baseline after investigational product application ]
    Percentage of adults and babies with edema on the arms at baseline after investigational product application

  27. Percentage With Edema on the Legs at Baseline After Investigational Product Application [ Time Frame: At baseline after investigational product application ]
    Percentage of adults and babies with edema on the legs at baseline after investigational product application

  28. Percentage With Edema on the Torso at Baseline After Investigational Product Application [ Time Frame: At baseline after investigational product application ]
    Percentage of adults and babies with edema on the torso at baseline after investigational product application

  29. Percentage With Edema on the Face at Day 1 [ Time Frame: At Day 1 ]
    Percentage of adults and babies with edema on the face at Day 1

  30. Percentage With Edema on the Arms at Day 1 [ Time Frame: At Day 1 ]
    Percentage of adults and babies with edema on the arms at Day 1

  31. Percentage With Edema on the Legs at Day 1 [ Time Frame: At Day 1 ]
    Percentage of adults and babies with edema on the legs at Day 1

  32. Percentage With Edema on the Torso at Day 1 [ Time Frame: At Day 1 ]
    Percentage of adults and babies with edema on the torso at Day 1

  33. Percentage With Edema on the Face at Day 7 [ Time Frame: At Day 7 ]
    Percentage of adults and babies with edema on the face at Day 7

  34. Percentage With Edema on the Arms at Day 7 [ Time Frame: At Day 7 ]
    Percentage of adults and babies with edema on the arms at Day 7

  35. Percentage With Edema on the Legs at Day 7 [ Time Frame: At Day 7 ]
    Percentage of adults and babies with edema on the legs at Day 7

  36. Percentage With Edema on the Torso at Day 7 [ Time Frame: At Day 7 ]
    Percentage of adults and babies with edema on the torso at Day 7

  37. Percentage With Edema on the Face at Day 14 [ Time Frame: At Day 14 ]
    Percentage of adults and babies with edema on the face at Day 14

  38. Percentage With Edema on the Arms at Day 14 [ Time Frame: At Day 14 ]
    Percentage of adults and babies with edema on the arms at Day 14

  39. Percentage With Edema on the Legs at Day 14 [ Time Frame: At Day 14 ]
    Percentage of adults and babies with edema on the legs at Day 14

  40. Percentage With Edema on the Torso at Day 14 [ Time Frame: At Day 14 ]
    Percentage of adults and babies with edema on the torso at Day 14

  41. Percentage With Scaling on the Face at Baseline Before Investigational Product Application [ Time Frame: At baseline before investigational product application ]
    Percentage of adults and babies with scaling on the face at baseline before investigational product application

  42. Percentage With Scaling on the Arms at Baseline Before Investigational Product Application [ Time Frame: At baseline before investigational product application ]
    Percentage of adults and babies with scaling on the arms at baseline before investigational product application

  43. Percentage With Scaling on the Legs at Baseline Before Investigational Product Application [ Time Frame: At baseline before investigational product application ]
    Percentage of adults and babies with scaling on the legs at baseline before investigational product application

  44. Percentage With Scaling on the Torso at Baseline Before Investigational Product Application [ Time Frame: At baseline before investigational product application ]
    Percentage of adults and babies with scaling on the torso at baseline before investigational product application

  45. Percentage With Scaling on the Face at Baseline After Investigational Product Application [ Time Frame: At baseline after investigational product application ]
    Percentage of adults and babies with scaling on the face at baseline after investigational product application

  46. Percentage With Scaling on the Arms at Baseline After Investigational Product Application [ Time Frame: At baseline after investigational product application ]
    Percentage of adults and babies with scaling on the arms at baseline after investigational product application

  47. Percentage With Scaling on the Legs at Baseline After Investigational Product Application [ Time Frame: At baseline after investigational product application ]
    Percentage of adults and babies with scaling on the legs at baseline after investigational product application

  48. Percentage With Scaling on the Torso at Baseline After Investigational Product Application [ Time Frame: At baseline after investigational product application ]
    Percentage of adults and babies with scaling on the torso at baseline after investigational product application

  49. Percentage With Scaling on the Face at Day 1 [ Time Frame: At Day 1 ]
    Percentage of adults and babies with scaling on the face at Day 1

  50. Percentage With Scaling on the Arms at Day 1 [ Time Frame: At Day 1 ]
    Percentage of adults and babies with scaling on the arms at Day 1

  51. Percentage With Scaling on the Legs at Day 1 [ Time Frame: At Day 1 ]
    Percentage of adults and babies with scaling on the legs at Day 1

  52. Percentage With Scaling on the Torso at Day 1 [ Time Frame: At Day 1 ]
    Percentage of adults and babies with scaling on the torso at Day 1

  53. Percentage With Scaling on the Face at Day 7 [ Time Frame: At Day 7 ]
    Percentage of adults and babies with scaling on the face at Day 7

  54. Percentage With Scaling on the Arms at Day 7 [ Time Frame: At Day 7 ]
    Percentage of adults and babies with scaling on the arms at Day 7

  55. Percentage With Scaling on the Legs at Day 7 [ Time Frame: At Day 7 ]
    Percentage of adults and babies with scaling on the legs at Day 7

  56. Percentage With Scaling on the Torso at Day 7 [ Time Frame: At Day 7 ]
    Percentage of adults and babies with scaling on the torso at Day 7

  57. Percentage With Scaling on the Face at Day 14 [ Time Frame: At Day 14 ]
    Percentage of adults and babies with scaling on the face at Day 14

  58. Percentage With Scaling on the Arms at Day 14 [ Time Frame: At Day 14 ]
    Percentage of adults and babies with scaling on the arms at Day 14

  59. Percentage With Scaling on the Legs at Day 14 [ Time Frame: At Day 14 ]
    Percentage of adults and babies with scaling on the legs at Day 14

  60. Percentage With Scaling on the Torso at Day 14 [ Time Frame: At Day 14 ]
    Percentage of adults and babies with scaling on the torso at Day 14



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female of any race or ethnicity, 6 months to 36 months of age and/or 18 years and above.
  2. Adult subjects only - Male or non-pregnant, non-lactating female agree to the contraceptive requirements (including female partners use of a highly effective form of birth control for 3 months.
  3. Diagnosed as having Eczema.
  4. Willing to stop the use of any non- assigned moisturizers and/or creams for the entire duration of the study.
  5. Willing to not introduce any new fragrances (e.g. cleansers, lotions, perfumes, etc.), or in the household environment (e.g. room fresheners, cleansing agents, laundry detergents, etc.) for the duration of the study.
  6. Willing to avoid excessive (more than 30 minutes) sun exposure without the use of their regular brand of sunscreen and protective clothing.
  7. Willing to not enter/use hot tub or whirlpool bath for the duration of the study.
  8. Willing to avoid the beach during the course of the study, and willing to document any activities at or in a swimming pool in the daily diary.

Exclusion Criteria:

  1. Use of a therapeutic (over the counter or prescription) body wash that contains an active ingredient for eczema.
  2. Adults Females who are pregnant (self-reported) or breastfeeding.
  3. Participation in any clinical study within 30 days of Visit 1.
  4. Atopic Dermatitis requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids.
  5. Requires greater than 2.0 mg/day inhaled or intranasal corticosteroids.
  6. Subjects who exhibit clinically active bacterial, fungal, or viral skin infections or those who are susceptible to cutaneous infections.
  7. Subjects who are currently on phototherapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02357940


Locations
United States, Florida
Hill-top Research, Inc
St. Petersburg, Florida, United States, 33714
United States, New Jersey
TKL Research Inc.
Fair Lawn, New Jersey, United States, 07410
Sponsors and Collaborators
Johnson & Johnson Consumer Inc. (J&JCI)
Investigators
Study Director: Amisha Parikh-Das, Ph.D. Johnson & Johnson Consumer Inc. (J&JCI)
Principal Investigator: Daniel Hogan, M.D. Hill-top Research Inc.
Principal Investigator: Ethlynn Schorr, M.D. TKL Research, Inc.

Responsible Party: Johnson & Johnson Consumer Inc. (J&JCI)
ClinicalTrials.gov Identifier: NCT02357940     History of Changes
Other Study ID Numbers: CO-140908134135-SBCT
First Posted: February 6, 2015    Key Record Dates
Results First Posted: November 15, 2016
Last Update Posted: January 10, 2017
Last Verified: November 2016

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) ):
Eczema
Skin Irritation

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases