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NCT02120833 · ClinicalTrials.gov registry record · Phase 3
A Test to Determine the Usefulness and Safety of a Cream Used on Babies With Dry Itchy Skin
A Phase 3 study, sponsored by Johnson & Johnson Consumer and Personal Products Worldwide.
- Completed
- Registry status
- Phase 3
- Development phase
- 51
- Enrollment target
NCT02120833: Completed Phase 3 study, sponsored by Johnson & Johnson Consumer and Personal Products Worldwide.
NCT02120833 is a Phase 3 study that has completed, run by Johnson & Johnson Consumer and Personal Products Worldwide. The registered enrollment target is 51 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02120833, a Phase 3 study, has completed, sponsored by Johnson & Johnson Consumer and Personal Products Worldwide.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 51 participants
- Enrollment target
Study Summary
This study is for infants with mild to moderate dry and itchy skin. This study will involve going to the doctor for 6 visits over 2 weeks. All participants' skin will be examined by a dermatologist to determine if they have atopic dermatitis and have an active mild to moderate eczema wound. Participant's parents/guardians will be asked a few questions to determine if their child qualifies for the study. Then all participants' caregivers will complete a questionnaire at the beginning of the study. The child's skin will be examined to rate the level of their eczema and a trained examiner will grade the looks and symptoms of their eczema. All parents or guardians will be instructed how to apply the test product and how to record usage on a diary card and then apply the test product. The test product will be applied at least 2 times per day or more as needed on all body areas, including the face affected throughout the study. One digital picture will be taken of one eczema wound. Another digital picture will be taken of the area around this wound. These pictures will be taken on Day 0 (Baseline), Day 3, and Day 14. Once product is applied the skin will be examined for any adverse events and all participants' caregivers will complete a questionnaire on study day 1, 3, 7 and 14.
Primary Outcome
The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.
Interventions
- DEVICE EpiCeram® Skin Barrier Emulsion
- DRUG Colloidal Oatmeal Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2014-03 |
| Est. Completion | 2014-11 |
| Phase | Phase 3 |
What the finished NCT02120833 record still lists
NCT02120833 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which EpiCeram® Skin Barrier Emulsion is the first listed.
NCT02120833 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02120833 about?
NCT02120833 is a clinical study titled "A Test to Determine the Usefulness and Safety of a Cream Used on Babies With Dry Itchy Skin". This study is for infants with mild to moderate dry and itchy skin. This study will involve going to the doctor for 6 visits over 2 weeks. All participants' skin will be examined by a dermatologist to determine if they have atopic dermatitis and have an active mild to moderate eczema wound. Particip...
What is the current status of trial NCT02120833?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 51 participants. The study started on 2014-03. Estimated completion is 2014-11.
What interventions are being tested in trial NCT02120833?
The interventions under investigation include: EpiCeram® Skin Barrier Emulsion (DEVICE), Colloidal Oatmeal Cream (DRUG).
Who is sponsoring clinical trial NCT02120833?
This trial is sponsored by Johnson & Johnson Consumer and Personal Products Worldwide, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02120833's enrollment target sits among peer trials
51 1842nd of 2000 higher than 157 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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