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TerminatedNCT00924508Updated Jan 31, 2014Results posted

Hydrogel Patch for the Treatment of Eczema

An interventional study of hydrogel patch and Triamcinolone (TAC) 0.1% cream in Eczema, sponsored by University of California, San Francisco. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-31.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment

Why this study was terminated
Loss of Funding
Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Eczema

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Keywords

  • eczema
  • at least 3 patches of eczema
03

In context

Eczema

1,084 studies on the registry are indexed under Eczema; 137 are open to participants now.

This study's enrollment of 23 is below the median of 80 across 861 interventional studies indexed under Eczema.

Browse Eczema studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • 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 · Drug: Triamcinolone (TAC) 0.1% cream

Interventions

  • Devicehydrogel patch

    occlusion of eczema with a hydrogel patch composed of an adhesive, thin, flexible, hydrogel layer on an impermeable urethane surface.

    Also known as: Occlusion, Patch, Hydrogel

  • DrugTriamcinolone (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.

    Also known as: Triamcinolone Acetonide cream, TAC cream [United States Pharmacopeia, (USP), 0.1%]

06

What researchers measure

Primary outcomes

  1. Change in Disease Severity: Percent Change in Mean EASI Score

    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.

    Time frame: Baseline, 6 weeks

Secondary outcomes

  1. Number of Adverse Events Associated With Treatment

    Time frame: 6 weeks

07

Results

Posted Nov 25, 2013
Limitations and caveats
Due to loss of funding, enrollment was terminated prior to intended accrual of 30 participants.

Participant flow

Eligible eczema patients from one U.S. clinical site were invited to participate

Participant flow — Overall Study
MilestoneTAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone
Started23
Completed20
Not completed3
Withdrew: Withdrawal by subject3

Outcome measures

PrimaryChange in Disease Severity: Percent Change in Mean EASI Score

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.

Time frame:
Baseline, 6 weeks
Reported as:
Mean · percentage change
Change in Disease Severity: Percent Change in Mean EASI Score
percentage changeHydrogel PatchTAC 0.1%Patch + TAC
Change in Disease Severity: Percent Change in Mean EASI Score-47 (-100 to 17)-56 (-100 to 0)-61 (-100 to 17)
Statistical analysis
  • Hydrogel Patch · t-test, 2 sided · p = <0.001
  • TAC 0.1% · t-test, 2 sided · p = <0.001
  • Patch + TAC · t-test, 2 sided · p = <0.001
SecondaryNumber of Adverse Events Associated With Treatment
Time frame:
6 weeks
Reported as:
Number · Adverse events
Number of Adverse Events Associated With Treatment
Adverse eventsHydrogel Patch Alone, TAC 0.1%, TAC + Patch
Number of Adverse Events Associated With Treatment0

Adverse events

Collected over 6 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone—0/23 (0%)0/23 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone
Mean45.6 ± 19.2
Sex: Female, Male
Sex: Female, Male(Participants)TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone
Female11
Male12
Region of Enrollment
Region of Enrollment(participants)TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone
United States23
08

Study locations

1 site
  • UCSF Psoriasis Skin and Treatment Center
    San Francisco, California 94118, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00924508
Lead sponsor
University of California, San Francisco
Collaborators
Teikoku Pharma USA, Inc.
Responsible party
Sponsor
First posted
Jun 19, 2009
Start date
Jul 2008
Primary completion
Sep 2011
Completion
Jul 2012
Results posted
Nov 25, 2013
Last update
Jan 31, 2014

Study contacts

John Koo, MD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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