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Completed

NCT Number: NCT02357940

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

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.

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Key information

Conditions

Atopic Dermatitis (AD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hill-top Research, Inc, St. Petersburg, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female of any race or ethnicity, 6 months to 36 months of age and/or 18 years and above.
  • 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.
  • Diagnosed as having Eczema.
  • Willing to stop the use of any non- assigned moisturizers and/or creams for the entire duration of the study.
  • 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.
  • Willing to avoid excessive (more than 30 minutes) sun exposure without the use of their regular brand of sunscreen and protective clothing.
  • Willing to not enter/use hot tub or whirlpool bath for the duration of the study.
  • 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

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

Treatment and study plan

Experimental Product

Drug

1% Colloidal Oatmeal Balm

Other names: Eczema Moisturizing Balm

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Consumer Inc. (J&JCI)

Industry

Registry information

Official study title

Clinical Trial to Evaluate the Tolerance of a Nighttime Moisturizing Balm on Babies and Adults With Mild to Moderate Atopic Dermatitis

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 6, 2015
Registry last updated
Jan 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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