CompletedPhase 4

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

United States20 participantsStarted 2010-02

Plain-language 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.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent Change of Trans Epidermal Water Loss (TEWL) With Use of Eucerin Lotion

Timeframe: Day 1 to Day 14

Percent Change of Trans Epidural Water Loss (TEWL) With the Use of Hydrogel Vehicle

Timeframe: Day 1 to Day 14

Trial details

NCT IDNCT01065714

SponsorDerm Research, PLLC

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-11

Results submitted2012-03-30

View on ClinicalTrials.gov More Atopic Dermatitis trials