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

This study has been completed.
Sponsor:
Collaborator:
Intendis, Inc.
Information provided by (Responsible Party):
Leon Kircik, M.D., Derm Research, PLLC
ClinicalTrials.gov Identifier:
NCT01065714
First received: February 8, 2010
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Atopic Dermatitis
Drug: Hydrogel vehicle
Drug: Eucerin Lotion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Derm Research, PLLC:

Primary Outcome Measures:
  • Percent Change of Trans Epidermal Water Loss (TEWL) With Use of Eucerin Lotion [ Time Frame: Day 1 to Day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 to Day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: No ]
    Five timed readings at (0, 15, 30, 45 and 60 minutes) were taken, using the Corneometer 825 meter, on participants using Hydrogel vehicle


Enrollment: 20
Study Start Date: February 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.)

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065714

Locations
United States, Kentucky
DermResearch, PLLC
Louisville, Kentucky, United States, 40217
Sponsors and Collaborators
Derm Research, PLLC
Intendis, Inc.
Investigators
Principal Investigator: Leon H. Kirick, M.D. DermResearch, PLLC
  More Information

No publications provided

Responsible Party: Leon Kircik, M.D., Principal Investigator, Derm Research, PLLC
ClinicalTrials.gov Identifier: NCT01065714     History of Changes
Other Study ID Numbers: HGV0901
Study First Received: February 8, 2010
Results First Received: March 30, 2012
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Derm Research, PLLC:
Transepidermal water loss
Epidermal barrier
Skin hydration

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on October 23, 2014