Overview
Trial to Determine the Therapeutic Benefit of an OTC Cream on Dry, Itchy Skin of Adults and Children With Eczema
Status:
Completed
Completed
Trial end date:
2016-04-01
2016-04-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The objective of this 1 week trial is to evaluate the efficacy of an over-the-counter (OTC) 1% colloidal oatmeal skin protectant cream in adults and children with mild to moderate AD.Phase:
Phase 2Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Johnson & Johnson Consumer Inc. (J&JCI)Treatments:
Decanoic acid
Criteria
Inclusion Criteria:1. Able to comprehend and follow the requirements of the study (including availability on
scheduled visit dates)
2. Male or female of any race or ethnicity, ages 12 and older
3. Diagnosed as having eczema
4. Willing to stop use of all non-assigned moisturizers and/or creams for the entire
duration of the study
Exclusion Criteria:
1. Known sensitivity to any investigational product ingredient
2. Females who are pregnant , breastfeeding , or planning on becoming pregnant during the
study
3. Individuals with a history of skin cancer
4. Use of a therapeutic (over-the-counter or prescription) body wash that contains an
active ingredient for eczema
5. Participation in any clinical study within 30 days of Visit 1
6. Active infection of any type at the start of the study
7. Diagnosed as having severe eczema
8. Has a compromised immune system
9. Individuals with any planned surgeries and/or invasive medical procedures during the
course of the study
10. Requires greater than 2.0mg/day inhaled or intranasal corticosteroids