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

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Derm Research, PLLC
• Collaborator: Bayer

Criteria

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.