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Hydrogel Patch for the Treatment of Eczema

This study has been terminated.
(Loss of Funding)
Sponsor:
Collaborator:
Teikoku Pharma USA
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00924508
First received: June 17, 2009
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

The primary objective of this clinical study is to determine whether occlusion of triamcinolone 0.1% cream (TAC) with hydrogel patch improves its efficacy in treating eczema. A secondary objective is to determine whether eczema improves under occlusion with hydrogel patch alone, without TAC.


Condition Intervention
Eczema
Device: hydrogel patch
Drug: Triamcinolone (TAC) 0.1% cream

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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Change in Disease Severity: Percent Change in Mean EASI Score [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Adverse Events Associated With Treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: July 2008
Study Completion Date: July 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Occlusion
  • Patch
  • Hydrogel
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:
  • Triamcinolone Acetonide cream
  • TAC cream [United States Pharmacopeia
  • (USP), 0.1%]

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
Criteria

Inclusion Criteria:

  1. Subject has signed the informed consent form and Health Insurance Portability and Accountability Act (HIPAA) authorization form;
  2. Male or female subject at least 12 years of age; subjects under 18 years of age will need parental or official guardian consent.
  3. 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.)
  4. 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;
  5. 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;
  6. 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;
  7. Subject must be reliable and mentally competent to complete study measurements;
  8. 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:

  1. Subjects with exclusively hand, face, foot, and/or groin dermatitis
  2. Known hypersensitivity to any component of the test medications;
  3. Pigmentation, extensive scarring, or pigmented lesions in affected areas that would interfere with evaluation of efficacy parameters;
  4. Clinically infected eczema at baseline.
  5. Any evidence of atrophy in the areas selected for treatment with topical corticosteroid;
  6. 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.
  7. Topical therapies (other than non-prescription emollients) on potential target lesions within one week of starting study treatment;
  8. Systemic therapy, phototherapy, or a systemic investigational therapy for eczema within 30 days prior to study entry;
  9. Subject is considered unreliable as to medication compliance or adherence to scheduled appointments as determined by the investigators.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924508

Locations
United States, California
UCSF Psoriasis Skin and Treatment Center
San Francisco, California, United States, 94118
Sponsors and Collaborators
University of California, San Francisco
Teikoku Pharma USA
Investigators
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
Results First Received: September 18, 2013
Last Updated: December 30, 2013
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
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Anti-Inflammatory Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014