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

• 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: Johnson & Johnson Consumer Inc. (J&JCI)
• Information provided by (Responsible Party): Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

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.

More Information

• Responsible Party: Johnson & Johnson Consumer Inc. (J&JCI)
• ClinicalTrials.gov Identifier: NCT02357940
• Other Study ID Numbers: CO-140908134135-SBCT
• First Posted: February 6, 2015
• 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, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases