Eczema
Conditions
Keywords
eczema, at least 3 patches of eczema
Brief 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.
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.
Interventions
DEVICEhydrogel patch
occlusion of eczema with a hydrogel patch composed of an adhesive, thin, flexible, hydrogel layer on an impermeable urethane surface.
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.
Sponsors
Teikoku Pharma USA, Inc.
University of California, San Francisco
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Disease Severity: Percent Change in Mean EASI Score | Baseline, 6 weeks | 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
| Measure | Time frame |
|---|---|
| Number of Adverse Events Associated With Treatment | 6 weeks |
Countries
United States
Participant flow
Recruitment details
Eligible eczema patients from one U.S. clinical site were invited to participate
Pre-assignment details
Consent was initially obtained from 23 participants, but 3 participants withdrew consent
Participants by arm
| Arm | Count |
|---|---|
| TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of lesion by hydrogel patch and 0.1% TAC, the second treated with 0.1% TAC without occlusion, and the third treated with occlusion of eczema lesion by hydrogel patch without TAC. | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone |
|---|---|
| Age, Continuous | 45.6 years STANDARD_DEVIATION 19.2 |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
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
Population: 3 of 23 enrolled participants withdrew consent and did not provide data for analysis. Each participant had 3 lesions treated in the study, one by each of 3 study treatments.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Hydrogel Patch | Change in Disease Severity: Percent Change in Mean EASI Score | -47 percentage change |
| TAC 0.1% | Change in Disease Severity: Percent Change in Mean EASI Score | -56 percentage change |
| Patch + TAC | Change in Disease Severity: Percent Change in Mean EASI Score | -61 percentage change |
Comparison: Baseline and post-treatment comparisonp-value: <0.001t-test, 2 sided
Comparison: Baseline and post-treatment comparisonp-value: <0.001t-test, 2 sided
Comparison: Baseline and post-treatment comparisonp-value: <0.001t-test, 2 sided
Secondary
Number of Adverse Events Associated With Treatment
Time frame: 6 weeks
Population: 3 of 23 enrolled participants withdrew consent and did not provide data for analysis. Each participant had 3 lesions treated in the study, one by each of 3 study treatments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydrogel Patch | Number of Adverse Events Associated With Treatment | 0 Adverse events |