Atopic dermatitis (mild to severe)
Conditions
Interventions
After a washout of any topical moisturizing products, any topical prescription treatments and any OTC treatments, apply the test product in the split-body twice per day for the 4-week treatment period
Sponsors
Thomas J. Stephens & Associates, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -15 years of age and older, females and males. -Individuals with clinically determined mild to severe atopic dermatitis by Hanifin & Rajka. -Individuals with a minimum of 1 active atopic dermatitis lesion, of mild to severe severity based on the ADSI. -The order of preference for the lesional sites are as follows: -Contra-lateral forearm lesions -Single forearm lesion -Contra-lateral lesions from other area -Single lesions from other areas
Exclusion criteria
Exclusion criteria: -Individuals with known allergies to any topical moisturizing product. -Individuals with any dermatological condition that would interfere with study assessments or increase the risk to the subjects. -Individuals who have any medical conditions which makes the candidate an inappropriate subject for study participation. -Individuals with uncontrolled medical conditions such as hypertension, thyroid disease, diabetes, etc. -Females who are pregnant or nursing or planning to become pregnant during the course of the study. -Individuals who are currently participating on any other clinical study, or have done so in the previous two weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in clinical grading scores hydration (Corneometer), and barrier (Tewameter) when comparing test product to baseline at post-baseline time points. The presence of pseudoceramide in the stratum corneum of test product treated skin. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in clinical grading scores, hydration (Corneometer), and barrier (Tewameter) when comparing test product to the vehicle moisturizer at post-baseline time points. No significant worsening in objective or subjective symptoms of skin irritation at post-baseline time points. A significantly greater proportion of positive responses versus negative responses of self-assessment questionnaires. | — |
Countries
North America
Contacts
Public ContactKoichi Ishida
Kao Corporation R&D Strategy
Outcome results
None listed