Hydorgel Patch for the Treatment of Eczema
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Purpose
The primary objective of this clinical study is to determine whether occlusion of triamcinolone 0.1% cream (TAC) used to treat eczema with hydrogel patch improves its efficacy. A secondary objective is to determine whether eczema improves under occlusion with hydrogel patch alone.
| Condition | Intervention |
|---|---|
|
Eczema |
Device: hydrogel and 0.1 % triamcinolone ointment |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- Percentage of Patients with significant improvement of eczema [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Percentage of Adverse Events Associated with treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | July 2012 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TAC ointment with hydrogel, hydrogel alone, no treatment
This is a single arm study. Each subject will have 3 target lesions; one treated with ointment and occlusion, the second treated wtih ointment alone, and the third treated wtih occlusion alone.
|
Device: hydrogel and 0.1 % triamcinolone ointment
occlusion of eczema patch with hydrogel and 0.1 % triamcinolone ointment, occlusion alone, and ointment alone
|
Detailed Description:
This will be a 6-week, open label, bilaterally-controlled single center study involving 30 subjects age 13 and older with eczema. The primary objective of this clinical study is to determine whether occlusion of triamcinolone 0.1% cream (TAC) used to treat eczema with hydrogel patch improves its efficacy. A secondary objective is to determine whether eczema improves under occlusion with hydrogel patch alone. All subjects will have 3 target lesions of similar severity followed throughout the study. Patients will apply hydrogel patch alone to the first lesion, TAC 0.1% cream to the second lesion, and TAC 0.1% cream occluded by hydrogel patch to the third lesion. All treatments are twice a day for a maximum of 4 weeks or until lesions are cleared. The modified Eczema Area and Severity Index (EASI) score will be used to evaluate each lesion.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject has signed the informed consent form and 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.
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00924508 History of Changes |
| Other Study ID Numbers: | Hydrogel for Eczema |
| Study First Received: | June 17, 2009 |
| Last Updated: | October 11, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
eczema at least 3 patches of eczema |
Additional relevant MeSH terms:
|
Eczema Dermatitis Skin Diseases Skin Diseases, Eczematous Triamcinolone hexacetonide Triamcinolone Triamcinolone Acetonide Triamcinolone diacetate Anti-Inflammatory Agents Therapeutic Uses |
Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013