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

Study Overview
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Brief Summary
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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.

Official Title
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Transepidermal Water Loss (TEWL) and Corneometry With Hydrogel Vehicle in the Treatment of Atopic Dermatitis - A Randomized, Investigator-Blind Pilot Study

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Hydrogel vehicle
* Drug: Eucerin Lotion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrogel vehicle<br>Parallel designed study. Split body treatment | Drug: Hydrogel vehicle<br>* Each morning and evening, gently wash the target area with warm water and gently pat dry with soft towel. Once dry place a small amount of Hydrogel vehicle onto the tip of your finger. Place a dab of the Hydrogel vehicle on either the left or right side of the body as instructed. (Do not use Hydrogel vehicle and Eucerin lotion on the same side of the body.)<br>|
| Active Comparator: Eucerin Lotion<br>Parallel study design. Split body study. | Drug: Eucerin Lotion<br>* Each morning and evening, gently wash the area with warm water and pat dry with a soft towel. Once dry, place a small amount of Eucerin lotion to the target area on either the left or right side of the body as instructed. (Do not use Eucerin and Hydrogel vehicle on the same side of the body.)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change of Trans Epidermal Water Loss (TEWL) With Use of Eucerin Lotion | 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 | Day 1 to Day 14 | 
| Percent Change of Trans Epidural Water Loss (TEWL) With the Use of Hydrogel Vehicle | 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 | Day 1 to Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With an Increase in Skin Hydration Using Eucerin Lotion on Targeted Area on One Half of Body | 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 | Baseline to 14 days | 
| Percentage of Participants With an Increase in Skin Hydration Using Hydrogel Vehicle on Targeted Area of One Half of Body. | Five timed readings at (0, 15, 30, 45 and 60 minutes) were taken, using the Corneometer 825 meter, on participants using Hydrogel vehicle | Baseline to 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transepidermal water loss, Epidermal barrier, Skin hydration