A Study to Investigate the Use of Hydrogel Vehicle in Maintaining the Skin Barrier in Persons With Atopic Dermatitis

Phase 4

Completed

Brief Summary: While the repair of the epidermal barrier in atopic dermatitis is of major importance in the treatment of atopic dermatitis, most of the vehicles used may actually cause a worsening of an impaired epidermal barrier. Hydrogel vehicle is anecdotally known to be moisturizing and hydrating.This study will compare the use of Hydrogel vehicle and Eucerin Lotion in maintaining the epidermal barrier in subjects with atopic dermatitis.

Recruitment & Eligibility

Inclusion Criteria

Definitive diagnosis of atopic dermatitis as characterized by Hanifin and Rajka criteria:
3 out of 4 major characteristics
At least 3 minor characteristics
Mild to moderate disease score of 2 or 3 by Investigator Global Assessment
Minimum 5% Body Surface Area at Baseline
Uniformly bilateral signs and symptoms of atopic dermatitis
Able to understand and comply with the requirements of the study and sign Informed Consent/HIPAA forms. Subjects under the legal age of consent must also have written informed consent of the parent or legal guardian.

Exclusion Criteria

Allergy or sensitivity to any component of the test articles.
Subjects who have not complied with the proper washout periods for prohibited medications.
Significant coagulation disorder or any medical condition that, in the opinion of the investigator, contraindicates the subject's participation in the study.
Recent alcohol or drug abuse is evident.
History of poor cooperation, non-compliance with medical treatment or unreliability
Participation in an investigational drug study within 30 days of the Baseline Visit.

Arm && Interventions

Group	Intervention	Description
Eucerin Lotion	Eucerin Lotion	Parallel study design. Split body study.
Hydrogel vehicle	Hydrogel vehicle	Parallel designed study. Split body treatment

Primary Outcome Measures

Name	Time	Method
Percent Change of Trans Epidermal Water Loss (TEWL) With Use of Eucerin Lotion	Day 1 to Day 14	The average of three sequential Tewameter 300 meter readings taken at a minimum of one minute intervals on targeted area of body half treated with Eucerin lotion
Percent Change of Trans Epidural Water Loss (TEWL) With the Use of Hydrogel Vehicle	Day 1 to Day 14	The average of three sequential Tewameter 300 meter readings taken at a minimum of one minute intervals on target areas of body half treated with Hydrogel vehicle

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With an Increase in Skin Hydration Using Eucerin Lotion on Targeted Area on One Half of Body	Baseline to 14 days	Five timed readings ( 0, 15, 30, 45 and 60 minutes) were taken using the Corneometer 825 meter on subjects using Eucerin lotion on targeted area on one half of body
Percentage of Participants With an Increase in Skin Hydration Using Hydrogel Vehicle on Targeted Area of One Half of Body.	Baseline to 14 days	Five timed readings at (0, 15, 30, 45 and 60 minutes) were taken, using the Corneometer 825 meter, on participants using Hydrogel vehicle