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

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Hydrogel vehicle

Eucerin Lotion

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Transepidermal water loss, Epidermal barrier, Skin hydration

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

DermResearch, PLLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hydrogel vehicle

Eucerin Lotion

Arm Description

Parallel designed study. Split body treatment

Parallel study design. Split body study.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT01065714

First Posted

February 8, 2010

Last Updated

April 22, 2013

Sponsor

Derm Research, PLLC

Collaborators

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01065714

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Derm Research, PLLC

Collaborators

Bayer

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

Transepidermal water loss, Epidermal barrier, Skin hydration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hydrogel vehicle

Arm Type

Experimental

Arm Description

Parallel designed study. Split body treatment

Arm Title

Eucerin Lotion

Arm Type

Active Comparator

Arm Description

Parallel study design. Split body study.

Intervention Type

Drug

Intervention Name(s)

Hydrogel vehicle

Intervention Description

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.)

Intervention Type

Drug

Intervention Name(s)

Eucerin Lotion

Intervention Description

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 Outcome Measure Information:

Title

Percent Change of Trans Epidermal Water Loss (TEWL) With Use of Eucerin Lotion

Description

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

Time Frame

Day 1 to Day 14

Title

Percent Change of Trans Epidural Water Loss (TEWL) With the Use of Hydrogel Vehicle

Description

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

Time Frame

Day 1 to Day 14

Secondary Outcome Measure Information:

Title

Percentage of Participants With an Increase in Skin Hydration Using Eucerin Lotion on Targeted Area on One Half of Body

Description

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

Time Frame

Baseline to 14 days

Title

Percentage of Participants With an Increase in Skin Hydration Using Hydrogel Vehicle on Targeted Area of One Half of Body.

Description

Five timed readings at (0, 15, 30, 45 and 60 minutes) were taken, using the Corneometer 825 meter, on participants using Hydrogel vehicle

Time Frame

Baseline to 14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leon H. Kirick, M.D.

Organizational Affiliation

DermResearch, PLLC

Official's Role

Principal Investigator

Facility Information:

Facility Name

DermResearch, PLLC

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40217

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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