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Atopic Dermatitis (AD)NCT02357940

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

A study testing Experimental Product in people with Atopic Dermatitis (AD), run by Johnson & Johnson Consumer Inc. (J&JCI) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 6 months and olderHealthy volunteers can take part
Conditions the study is for
Atopic Dermatitis (AD)
What is being tested?
Experimental Product
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
2 sitesUnited States
Study dates
Jan 2015to Jan 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • TKL Research Inc.

    Fair Lawn, New Jersey, 07410

  • Hill-top Research, Inc

    St. Petersburg, Florida, 33714

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Experimental Product
Keywords
Eczema, Skin Irritation
Medical subject headings
Dermatitis, Atopic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental ProductDrug

    Also called Eczema Moisturizing Balm

    1% Colloidal Oatmeal Balm

Study groups in NCT02357940
Study groupRoleWhat they receive
Adult Tolerance AssessmentExperimentalApply thin layer of experimental product to the affected skin areas at least 2 times per day and massage gently into skin
Receives: Drug: Experimental Product
Baby (infants, toddlers, young children) Tolerance AssessmentExperimentalApply thin layer of experimental product to the affected skin areas at least 2 times per day and massage gently into skin
Receives: Drug: Experimental Product

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage With Erythema on the Face at Baseline Before Investigational Product Application

    Percentage of adults and babies with erythema on the face at baseline before investigational product application

    Measured: At baseline before investigational product application

  2. Percentage With Erythema on the Arms at Baseline Before Investigational Product Application

    Percentage of adults and babies with erythema on the arms at baseline before investigational product application

    Measured: At baseline before investigational product application

  3. Percentage With Erythema on the Legs at Baseline Before Investigational Product Application

    Percentage of adults and babies with erythema on the legs at baseline before investigational product application

    Measured: At baseline before investigational product application

  4. Percentage With Erythema on the Torso at Baseline Before Investigational Product Application

    Percentage of adults and babies with erythema on the torso at baseline before investigational product application

    Measured: At baseline before investigational product application

  5. Percentage With Erythema on the Face at Baseline After Investigational Product Application

    Percentage of adults and babies with erythema on the face at baseline after investigational product application

    Measured: At baseline after investigational product application

  6. Percentage With Erythema on the Arms at Baseline After Investigational Product Application

    Percentage of adults and babies with erythema on the arms at baseline after investigational product application

    Measured: At baseline after investigational product application

  7. Percentage With Erythema on the Legs at Baseline After Investigational Product Application

    Percentage of adults and babies with erythema on the legs at baseline after investigational product application

    Measured: At baseline after investigational product application

  8. Percentage With Erythema on the Torso at Baseline After Investigational Product Application

    Percentage of adults and babies with erythema on the torso at baseline after investigational product application

    Measured: At baseline after investigational product application

  9. Percentage With Erythema on the Face at Day 1

    Percentage of adults and babies with erythema on the face at Day 1

    Measured: At Day 1

  10. Percentage With Erythema on the Arms at Day 1

    Percentage of adults and babies with erythema on the arms at Day 1

    Measured: At Day 1

  11. Percentage With Erythema on the Legs at Day 1

    Percentage of adults and babies with erythema on the legs at Day 1

    Measured: At Day 1

  12. Percentage With Erythema on the Torso at Day 1

    Percentage of adults and babies with erythema on the torso at Day 1

    Measured: At Day 1

  13. Percentage With Erythema on the Face at Day 7

    Percentage of adults and babies with erythema on the face at Day 7

    Measured: At Day 7

  14. Percentage With Erythema on the Arms at Day 7

    Percentage of adults and babies with erythema on the arms at Day 7

    Measured: At Day 7

  15. Percentage With Erythema on the Legs at Day 7

    Percentage of adults and babies with erythema on the legs at Day 7

    Measured: At Day 7

  16. Percentage With Erythema on the Torso at Day 7

    Percentage of adults and babies with erythema on the torso at Day 7

    Measured: At Day 7

  17. Percentage With Erythema on the Face at Day 14

    Percentage of adults and babies with erythema on the face at Day 14

    Measured: At Day 14

  18. Percentage With Erythema on the Arms at Day 14

    Percentage of adults and babies with erythema on the arms at Day 14

    Measured: At Day 14

  19. Percentage With Erythema on the Legs at Day 14

    Percentage of adults and babies with erythema on the legs at Day 14

    Measured: At Day 14

  20. Percentage With Erythema on the Torso at Day 14

    Percentage of adults and babies with erythema on the torso at Day 14

    Measured: At Day 14

  21. Percentage With Edema on the Face at Baseline Before Investigational Product Application

    Percentage of adults and babies with edema on the face at baseline before investigational product application

    Measured: At baseline before investigational product application

  22. Percentage With Edema on the Arms at Baseline Before Investigational Product Application

    Percentage of adults and babies with edema on the arms at baseline before investigational product application

    Measured: At baseline before investigational product application

  23. Percentage With Edema on the Legs at Baseline Before Investigational Product Application

    Percentage of adults and babies with edema on the legs at baseline before investigational product application

    Measured: At baseline before investigational product application

  24. Percentage With Edema on the Torso at Baseline Before Investigational Product Application

    Percentage of adults and babies with edema on the torso at baseline before investigational product application

    Measured: At baseline before investigational product application

  25. Percentage With Edema on the Face at Baseline After Investigational Product Application

    Percentage of adults and babies with edema on the face at baseline after investigational product application

    Measured: At baseline after investigational product application

  26. Percentage With Edema on the Arms at Baseline After Investigational Product Application

    Percentage of adults and babies with edema on the arms at baseline after investigational product application

    Measured: At baseline after investigational product application

  27. Percentage With Edema on the Legs at Baseline After Investigational Product Application

    Percentage of adults and babies with edema on the legs at baseline after investigational product application

    Measured: At baseline after investigational product application

  28. Percentage With Edema on the Torso at Baseline After Investigational Product Application

    Percentage of adults and babies with edema on the torso at baseline after investigational product application

    Measured: At baseline after investigational product application

  29. Percentage With Edema on the Face at Day 1

    Percentage of adults and babies with edema on the face at Day 1

    Measured: At Day 1

  30. Percentage With Edema on the Arms at Day 1

    Percentage of adults and babies with edema on the arms at Day 1

    Measured: At Day 1

  31. Percentage With Edema on the Legs at Day 1

    Percentage of adults and babies with edema on the legs at Day 1

    Measured: At Day 1

  32. Percentage With Edema on the Torso at Day 1

    Percentage of adults and babies with edema on the torso at Day 1

    Measured: At Day 1

  33. Percentage With Edema on the Face at Day 7

    Percentage of adults and babies with edema on the face at Day 7

    Measured: At Day 7

  34. Percentage With Edema on the Arms at Day 7

    Percentage of adults and babies with edema on the arms at Day 7

    Measured: At Day 7

  35. Percentage With Edema on the Legs at Day 7

    Percentage of adults and babies with edema on the legs at Day 7

    Measured: At Day 7

  36. Percentage With Edema on the Torso at Day 7

    Percentage of adults and babies with edema on the torso at Day 7

    Measured: At Day 7

  37. Percentage With Edema on the Face at Day 14

    Percentage of adults and babies with edema on the face at Day 14

    Measured: At Day 14

  38. Percentage With Edema on the Arms at Day 14

    Percentage of adults and babies with edema on the arms at Day 14

    Measured: At Day 14

  39. Percentage With Edema on the Legs at Day 14

    Percentage of adults and babies with edema on the legs at Day 14

    Measured: At Day 14

  40. Percentage With Edema on the Torso at Day 14

    Percentage of adults and babies with edema on the torso at Day 14

    Measured: At Day 14

  41. Percentage With Scaling on the Face at Baseline Before Investigational Product Application

    Percentage of adults and babies with scaling on the face at baseline before investigational product application

    Measured: At baseline before investigational product application

  42. Percentage With Scaling on the Arms at Baseline Before Investigational Product Application

    Percentage of adults and babies with scaling on the arms at baseline before investigational product application

    Measured: At baseline before investigational product application

  43. Percentage With Scaling on the Legs at Baseline Before Investigational Product Application

    Percentage of adults and babies with scaling on the legs at baseline before investigational product application

    Measured: At baseline before investigational product application

  44. Percentage With Scaling on the Torso at Baseline Before Investigational Product Application

    Percentage of adults and babies with scaling on the torso at baseline before investigational product application

    Measured: At baseline before investigational product application

  45. Percentage With Scaling on the Face at Baseline After Investigational Product Application

    Percentage of adults and babies with scaling on the face at baseline after investigational product application

    Measured: At baseline after investigational product application

  46. Percentage With Scaling on the Arms at Baseline After Investigational Product Application

    Percentage of adults and babies with scaling on the arms at baseline after investigational product application

    Measured: At baseline after investigational product application

  47. Percentage With Scaling on the Legs at Baseline After Investigational Product Application

    Percentage of adults and babies with scaling on the legs at baseline after investigational product application

    Measured: At baseline after investigational product application

  48. Percentage With Scaling on the Torso at Baseline After Investigational Product Application

    Percentage of adults and babies with scaling on the torso at baseline after investigational product application

    Measured: At baseline after investigational product application

  49. Percentage With Scaling on the Face at Day 1

    Percentage of adults and babies with scaling on the face at Day 1

    Measured: At Day 1

  50. Percentage With Scaling on the Arms at Day 1

    Percentage of adults and babies with scaling on the arms at Day 1

    Measured: At Day 1

  51. Percentage With Scaling on the Legs at Day 1

    Percentage of adults and babies with scaling on the legs at Day 1

    Measured: At Day 1

  52. Percentage With Scaling on the Torso at Day 1

    Percentage of adults and babies with scaling on the torso at Day 1

    Measured: At Day 1

  53. Percentage With Scaling on the Face at Day 7

    Percentage of adults and babies with scaling on the face at Day 7

    Measured: At Day 7

  54. Percentage With Scaling on the Arms at Day 7

    Percentage of adults and babies with scaling on the arms at Day 7

    Measured: At Day 7

  55. Percentage With Scaling on the Legs at Day 7

    Percentage of adults and babies with scaling on the legs at Day 7

    Measured: At Day 7

  56. Percentage With Scaling on the Torso at Day 7

    Percentage of adults and babies with scaling on the torso at Day 7

    Measured: At Day 7

  57. Percentage With Scaling on the Face at Day 14

    Percentage of adults and babies with scaling on the face at Day 14

    Measured: At Day 14

  58. Percentage With Scaling on the Arms at Day 14

    Percentage of adults and babies with scaling on the arms at Day 14

    Measured: At Day 14

  59. Percentage With Scaling on the Legs at Day 14

    Percentage of adults and babies with scaling on the legs at Day 14

    Measured: At Day 14

  60. Percentage With Scaling on the Torso at Day 14

    Percentage of adults and babies with scaling on the torso at Day 14

    Measured: At Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02357940
Sponsor's protocol ID
CO-140908134135-SBCT
Status last verified
Nov 2016
First submitted
3 Feb 2015
Last updated
10 Jan 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Experimental Product in people with Atopic Dermatitis (AD), run by Johnson & Johnson Consumer Inc. (J&JCI) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage With Erythema on the Face at Baseline Before Investigational Product Application (time frame: At baseline before investigational product application). The study lists 60 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02357940.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2017.

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