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

• ClinicalTrials.gov Identifier: NCT01065714
• Recruitment Status: Completed
• First Posted: February 9, 2010
• Results First Posted: April 25, 2013
• Last Update Posted: April 25, 2013
• Sponsor: Derm Research, PLLC
• Collaborator: Bayer
• Information provided by (Responsible Party): Leon Kircik, M.D., Derm Research, PLLC

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis	Drug: Hydrogel vehicle; Drug: Eucerin Lotion	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Transepidermal Water Loss (TEWL) and Corneometry With Hydrogel Vehicle in the Treatment of Atopic Dermatitis - A Randomized, Investigator-Blind Pilot Study
• Study Start Date: February 2010
• Actual Primary Completion Date: November 2010
• Actual Study Completion Date: November 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Hydrogel vehicle; Parallel designed study. Split body treatment	Drug: Hydrogel vehicle; 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.)
Active Comparator: Eucerin Lotion; Parallel study design. Split body study.	Drug: Eucerin Lotion; 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.)

Outcome Measures

Primary Outcome Measures :

1. Percent Change of Trans Epidermal Water Loss (TEWL) With Use of Eucerin Lotion [ Time Frame: 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
2. Percent Change of Trans Epidural Water Loss (TEWL) With the Use of Hydrogel Vehicle [ Time Frame: 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 :

1. Percentage of Participants With an Increase in Skin Hydration Using Eucerin Lotion on Targeted Area on One Half of Body [ Time Frame: 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
2. Percentage of Participants With an Increase in Skin Hydration Using Hydrogel Vehicle on Targeted Area of One Half of Body. [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Kentucky

DermResearch, PLLC

Louisville, Kentucky, United States, 40217

Sponsors and Collaborators

Derm Research, PLLC

Bayer

Investigators

• Principal Investigator: Leon H. Kirick, M.D.; DermResearch, PLLC

More Information

• Responsible Party: Leon Kircik, M.D., Principal Investigator, Derm Research, PLLC
• ClinicalTrials.gov Identifier: NCT01065714
• Other Study ID Numbers: HGV0901
• First Posted: February 9, 2010
• Results First Posted: April 25, 2013
• Last Update Posted: April 25, 2013
• Last Verified: April 2013

Keywords provided by Leon Kircik, M.D., Derm Research, PLLC:

Transepidermal water loss; Epidermal barrier; Skin hydration

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases