Hydrogel Patch for the Treatment of Eczema

Last updated: December 30, 2013
Sponsor: University of California, San Francisco
Overall Status: Terminated

Phase

N/A

Condition

Dermatitis, Atopic

Atopic Dermatitis

Allergy

Treatment

N/A

Clinical Study ID

NCT00924508
Hydrogel for Eczema
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject has signed the informed consent form and Health Insurance Portability andAccountability Act (HIPAA) authorization form;

  2. Male or female subject at least 12 years of age; subjects under 18 years of age willneed parental or official guardian consent.

  3. A diagnosis of eczema with at least three lesions no larger than 7 by 7 cm on eitherthe trunk, arms, or legs that would serve as target lesions. The lesions must be wideenough apart so that there is no overlap of hydrogel patches. All three lesions musthave at least 5 out of 12 points on the modified EASI scale. Each of the three lesionsmust have no greater than 1 point difference from each other on the modified EASIscore. (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 willbe preferentially selected as the target lesions.)

  4. Any additional diagnoses must, in the investigator's opinion, not preclude the subjectfrom safely participating in this study or interfere with the evaluation of thesubject's eczema;

  5. Subject is able to completely discontinue the use of any medication or therapy (otherthan 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 ortherapy (e.g. oral medications, phototherapy, herbal remedies, or acupuncture) forrelief 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, attendstudy visits, and comply with the restrictions during the study.

Exclusion

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 wouldinterfere with evaluation of efficacy parameters;

  4. Clinically infected eczema at baseline.

  5. Any evidence of atrophy in the areas selected for treatment with topicalcorticosteroid;

  6. Subjects requiring any other medication (topical or systemic) that may affect thecourse of the disease during the study period (e.g. oral corticosteroids,immunosuppressants, antibiotics, sedating antihistamines). Inhaled steroids will bepermitted.

  7. Topical therapies (other than non-prescription emollients) on potential target lesionswithin one week of starting study treatment;

  8. Systemic therapy, phototherapy, or a systemic investigational therapy for eczemawithin 30 days prior to study entry;

  9. Subject is considered unreliable as to medication compliance or adherence to scheduledappointments as determined by the investigators.

Study Design

Total Participants: 23
Study Start date:
July 01, 2008
Estimated Completion Date:
July 31, 2012

Study 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.

Connect with a study center

  • UCSF Psoriasis Skin and Treatment Center

    San Francisco, California 94118
    United States

    Site Not Available

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