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
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.
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.
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 →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.
Exclusion Criteria:
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
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
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%]
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
Number of Adverse Events Associated With Treatment
Time frame: 6 weeks
Eligible eczema patients from one U.S. clinical site were invited to participate
| Milestone | TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone |
|---|---|
| Started | 23 |
| Completed | 20 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 3 |
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.
| percentage change | Hydrogel Patch | TAC 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) |
| Adverse events | Hydrogel Patch Alone, TAC 0.1%, TAC + Patch |
|---|---|
| Number of Adverse Events Associated With Treatment | 0 |
Collected over 6 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone | — | 0/23 (0%) | 0/23 (0%) |
| Age, Continuous(years) | TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone |
|---|---|
| Mean | 45.6 ± 19.2 |
| Sex: Female, Male(Participants) | TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone |
|---|---|
| Female | 11 |
| Male | 12 |
| Region of Enrollment(participants) | TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone |
|---|---|
| United States | 23 |
This study is terminated, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, San Francisco