Clinical trial NCT01065714: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Keywords: Transepidermal water loss
Epidermal barrier
Skin hydration
Lead sponsor: Derm Research, PLLC
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2010-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percent Change of Trans Epidermal Water Loss (TEWL) With Use of Eucerin Lotion
timeFrame: Day 1 to Day 14
measure: Percent Change of Trans Epidural Water Loss (TEWL) With the Use of Hydrogel Vehicle
timeFrame: Day 1 to Day 14
Secondary outcomes:
measure: Percentage of Participants With an Increase in Skin Hydration Using Eucerin Lotion on Targeted Area on One Half of Body
timeFrame: Baseline to 14 days
measure: Percentage of Participants With an Increase in Skin Hydration Using Hydrogel Vehicle on Targeted Area of One Half of Body.
timeFrame: Baseline to 14 days
Other outcomes:
Locations:
city: Louisville
country: United States
facility: DermResearch, PLLC
state: Kentucky
Study officials:
affiliation: DermResearch, PLLC
name: Leon H. Kirick, M.D.
role: PRINCIPAL_INVESTIGATOR
References: