Trial to Determine the Therapeutic Benefit of an OTC Cream on Dry, Itchy Skin of Adults and Children With Eczema



Status:Recruiting
Conditions:Allergy, Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Otolaryngology
Healthy:No
Age Range:12 - Any
Updated:4/21/2016
Start Date:February 2016
End Date:June 2016
Contact:Julio Puth, DPT, CCRP
Email:jputh@its.jnj.com
Phone:215-273-7062

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A Clinical Trial to Determine the Therapeutic Benefit of an Investigational Over-The-Counter Cream on Dry, Itchy Skin of Adults and Children With Atopic Dermatitis.

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.

Approximately 60 subjects will be enrolled to ensure 52 subjects complete the study (39
subjects: active treatment and 13 subjects: positive control).

Adults and children (ages 12 and over) will receive either a marketed or not yet marketed
investigational product for the treatment of eczema. Subjects will be asked to stop use of
prescription and all eczema treatments 2 days before the start of the study and during the
study. Subjects will apply study product as indicated for 7 days to affected areas.

Subjects will record treatment use in a daily diary and complete questionnaires. A
dermatologist will examine and score the eczema and symptoms. Skin moisture levels will also
be tested.

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
We found this trial at
2
sites
Richardson, Texas 75081
Phone: 972-392-1529
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Richardson, TX
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Colorado Springs, Colorado 80915
Phone: 719-637-2828
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Colorado Springs, CO
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