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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change in Disease Severity: Percent Change in Mean EASI Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has signed the informed consent form and Health Insurance Portability and Accountability Act (HIPAA) authorization form;
- •Male or female subject at least 12 years of age; subjects under 18 years of age will need parental or official guardian consent.
- •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.)
- •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;
- •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;
- •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;
- •Subject must be reliable and mentally competent to complete study measurements;
- •Subject is able to understand and agrees to comply with study requirements, attend study visits, and comply with the restrictions during the study.
排除标准
- •Subjects with exclusively hand, face, foot, and/or groin dermatitis
- •Known hypersensitivity to any component of the test medications;
- •Pigmentation, extensive scarring, or pigmented lesions in affected areas that would interfere with evaluation of efficacy parameters;
- •Clinically infected eczema at baseline.
- •Any evidence of atrophy in the areas selected for treatment with topical corticosteroid;
- •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.
- •Topical therapies (other than non-prescription emollients) on potential target lesions within one week of starting study treatment;
- •Systemic therapy, phototherapy, or a systemic investigational therapy for eczema within 30 days prior to study entry;
- •Subject is considered unreliable as to medication compliance or adherence to scheduled appointments as determined by the investigators.
研究组 & 干预措施
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.
干预措施: hydrogel patch (Device)
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.
干预措施: Triamcinolone (TAC) 0.1% cream (Drug)
结局指标
主要结局
Change in Disease Severity: Percent Change in Mean EASI Score
时间窗: 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.
次要结局
- Number of Adverse Events Associated With Treatment(6 weeks)