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

• Hydrogel vehicle (Drug): 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.)
• Eucerin Lotion (Drug): 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.)

Primary outcomes

• 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 outcomes

• 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

Sex: All, ages: 12 Years to any

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.

Participant flow

Outcome results

• Percent Change of Trans Epidermal Water Loss (TEWL) With Use of Eucerin Lotion (Primary), Median, percent change: Skin Barrier Function With Eucerin Lotion 21.4 (-66.8 to 214.8)
• Percent Change of Trans Epidural Water Loss (TEWL) With the Use of Hydrogel Vehicle (Primary), Median, percent change: Skin Barrier Function With Hydrogel Vehicle 4.2 (-76.9 to 57.9)
• Percentage of Participants With an Increase in Skin Hydration Using Eucerin Lotion on Targeted Area on One Half of Body (Secondary), Mean, Percentage of participants: Skin Hydration With Eucerin 33.5 +/- 72.2
• Percentage of Participants With an Increase in Skin Hydration Using Hydrogel Vehicle on Targeted Area of One Half of Body. (Secondary), Mean, percentage of participants: Skin Hydration With Hydrogel 32.3 +/- 51.5

Adverse events

Limitations and caveats: Small number of participants, pilot study, short term

• Leon H. Kirick, M.D., Principal investigator, DermResearch, PLLC