Skip to main content
OpenTrials
Completed

NCT Number: NCT01065714

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

DermResearch, PLLC

Louisville, Kentucky, 40217, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Derm Research, PLLC

Other

Collaborators

  • Bayer

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 9, 2010
Registry last updated
Apr 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.