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

NCT01065714 | Completed Phase 4 Results

• 1 other identifier: HGV0901
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

Transepidermal water loss; Epidermal barrier; Skin hydration

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

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

  Baseline to 14 days

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

  Baseline to 14 days

Study Arms (2)

Hydrogel vehicle

EXPERIMENTAL

Parallel designed study. Split body treatment

Drug: Hydrogel vehicle

Eucerin Lotion

ACTIVE COMPARATOR

Parallel study design. Split body study.

Drug: Eucerin Lotion

Interventions

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.)

Hydrogel vehicle

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.)

Eucerin Lotion

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Definitive diagnosis of atopic dermatitis as characterized by Hanifin and Rajka criteria:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Derm Research, PLLC: lead
• Bayer: collaborator

Study Sites (1)

DermResearch, PLLC

Louisville, Kentucky, 40217, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Hydrogels

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Gels; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

Small number of participants, pilot study, short term

Results Point of Contact

• Title: Leon Kircik, M.D.
• Organization: DermResearch, PLLC

wedoderm@yahoo.com

502-451-9000

Study Officials

• Leon H. Kirick, M.D.

  DermResearch, PLLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 9, 2010
• Study Start: February 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: April 25, 2013
• Results First Posted: April 25, 2013

Record last verified: 2013-04

Locations

US (1)