Phase 4 N=20 Randomized Single-blind Treatment

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

Atopic Dermatitis

Bottom Line

View on ClinicalTrials.gov: NCT01065714 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2013

Primary outcome: Primary: Percent Change of Trans Epidermal Water Loss (TEWL) With Use of Eucerin Lotion — 21.4 percent change

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Hydrogel vehicle (Drug); Eucerin Lotion (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Derm Research, PLLC
Primary completion: Nov 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change of Trans Epidermal Water Loss (TEWL) With Use of Eucerin Lotion	21.4	—
PRIMARY Percent Change of Trans Epidural Water Loss (TEWL) With the Use of Hydrogel Vehicle	4.2	—
SECONDARY Percentage of Participants With an Increase in Skin Hydration Using Eucerin Lotion on Targeted Area on One Half of Body	33.5	—
SECONDARY Percentage of Participants With an Increase in Skin Hydration Using Hydrogel Vehicle on Targeted Area of One Half of Body.	32.3	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01065714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.