Hydrogel Patch for the Treatment of Eczema
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00924508 |
Recruitment Status :
Terminated
(Loss of Funding)
First Posted : June 19, 2009
Results First Posted : November 25, 2013
Last Update Posted : January 31, 2014
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Eczema | Device: hydrogel patch Drug: Triamcinolone (TAC) 0.1% cream | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 23 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Study to Compare the Efficacy of Triamcinolone 0.1% Cream Occluded With Hydrogel Patch to Triamcinolone 0.1% Cream Without Occlusion in the Treatment of Eczema |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | September 2011 |
Actual Study Completion Date : | July 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Patch + cream, patch alone, cream alone
This is a single arm study. Each subject will have 3 target lesions; one treated with TAC 0.1% cream and hydrogel patch (occlusion), the second treated with cream alone, and the third treated with occlusion alone.
|
Device: hydrogel patch
occlusion of eczema with a hydrogel patch composed of an adhesive, thin, flexible, hydrogel layer on an impermeable urethane surface.
Other Names:
Drug: Triamcinolone (TAC) 0.1% cream Triamcinolone Acetonide (triamcinolone acetonide cream) is a topical corticosteroid used as anti-inflammatory and antipruritic agent. Each gram of TAC Cream USP, 0.1% contains 1 mg Triamcinolone Acetonide (triamcinolone acetonide cream) in a cream base consisting of cetyl alcohol, glyceryl monostearate, cetyl esters wax, isopropyl palmitate, polysorbate-60, polysorbate-80, propylene glycol and purified water.
Other Names:
|
- Change in Disease Severity: Percent Change in Mean EASI Score [ Time Frame: Baseline, 6 weeks ]Percent change in mean EASI score week 0 to week 6: Each lesion was scored using a 12-point modified Eczema Area and Severity Index (EASI) at baseline and 2 weeks after the 4-week treatment period (week6). An experienced evaluator assessed each lesion on the severity of 4 domains, with higher scores indicating more severity: 1) intensity of redness (erythema), 2) thickness (induration, papulation, oedema), 3) scratching (excoriation) and 4) lichenification (lined skin) as as none (0), mild (1), moderate (2) and severe (3). Pictorial and descriptive instructions guided the evaluator in scoring the lesions based on visual appearance.
- Number of Adverse Events Associated With Treatment [ Time Frame: 6 weeks ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject has signed the informed consent form and Health Insurance Portability and Accountability Act (HIPAA) authorization form;
- Male or female subject at least 12 years of age; subjects under 18 years of age will need parental or official guardian consent.
- A diagnosis of eczema with at least three lesions no larger than 7 by 7 cm on either the trunk, arms, or legs that would serve as target lesions. The lesions must be wide enough apart so that there is no overlap of hydrogel patches. All three lesions must have at least 5 out of 12 points on the modified EASI scale. Each of the three lesions must have no greater than 1 point difference from each other on the modified EASI score. (If the subject can identify specific eczema lesions that are more pruritic, recalcitrant and/or tend to initiate the itch-scratch cycle, then those lesions will be preferentially selected as the target lesions.)
- Any additional diagnoses must, in the investigator's opinion, not preclude the subject from safely participating in this study or interfere with the evaluation of the subject's eczema;
- Subject is able to completely discontinue the use of any medication or therapy (other than study medications) for relief of eczema in the target areas to be treated;
- Subject is able to completely discontinue the use of any systemic medication or therapy (e.g. oral medications, phototherapy, herbal remedies, or acupuncture) for relief of eczema;
- Subject must be reliable and mentally competent to complete study measurements;
- Subject is able to understand and agrees to comply with study requirements, attend study visits, and comply with the restrictions during the study.
Exclusion Criteria:
- Subjects with exclusively hand, face, foot, and/or groin dermatitis
- Known hypersensitivity to any component of the test medications;
- Pigmentation, extensive scarring, or pigmented lesions in affected areas that would interfere with evaluation of efficacy parameters;
- Clinically infected eczema at baseline.
- Any evidence of atrophy in the areas selected for treatment with topical corticosteroid;
- Subjects requiring any other medication (topical or systemic) that may affect the course of the disease during the study period (e.g. oral corticosteroids, immunosuppressants, antibiotics, sedating antihistamines). Inhaled steroids will be permitted.
- Topical therapies (other than non-prescription emollients) on potential target lesions within one week of starting study treatment;
- Systemic therapy, phototherapy, or a systemic investigational therapy for eczema within 30 days prior to study entry;
- Subject is considered unreliable as to medication compliance or adherence to scheduled appointments as determined by the investigators.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924508
United States, California | |
UCSF Psoriasis Skin and Treatment Center | |
San Francisco, California, United States, 94118 |
Principal Investigator: | John Koo, MD | University of California, San Francisco |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00924508 |
Other Study ID Numbers: |
Hydrogel for Eczema |
First Posted: | June 19, 2009 Key Record Dates |
Results First Posted: | November 25, 2013 |
Last Update Posted: | January 31, 2014 |
Last Verified: | December 2013 |
eczema at least 3 patches of eczema |
Eczema Dermatitis Skin Diseases Skin Diseases, Eczematous Triamcinolone Triamcinolone Acetonide Triamcinolone hexacetonide Triamcinolone diacetate Anti-Inflammatory Agents |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |