A Test to Determine the Usefulness and Safety of a Cream Used on Babies With Dry Itchy Skin
Public ClinicalTrials.gov record NCT02120833. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-Center Clinical Trial to Evaluate the Efficacy of an Over-the-Counter Cream in the Management of Mild to Moderate Atopic Dermatitis in Infants and Toddlers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02120833
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 51 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Months to 35 Months
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2014
- Primary completion
- Oct 31, 2014
- Completion
- Oct 31, 2014
- Last update posted
- Jan 12, 2017
2014
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Thomas J. Stephens and Associates, Colorado Research Center | Colorado Springs | Colorado | 80915 | — |
| Thomas J. Stephens and Associates, Dallas Research Center | Richardson | Texas | 75081 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02120833, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 12, 2017 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02120833 live on ClinicalTrials.gov.