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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01065714
• Other study ID #: HGV0901
• Status: Completed
• Phase: Phase 4
• First received: February 8, 2010
• Last updated: April 22, 2013
• Start date: February 2010
• Est. completion date: November 2010

Study information

• Verified date: April 2013
• Source: Derm Research, PLLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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.)
• 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.)

Locations

Country	Name	City	State
United States	DermResearch, PLLC	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Derm Research, PLLC	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No