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临床试验/NCT06244212
NCT06244212招募中不适用

Topical Treatment for Atopic Dermatitis

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Amount of Topical Medication Dispensed - Standard of Care Group

研究概览

简要总结

Medication adherence is a poorly studied phenomenon that challenges both patients and physicians. 50% of individuals with chronic disease are not adherent to their medication regimen. Within the United States, non-adherence to medical treatment leads to approximately $100 billion in hospital admission costs. While the issue of adherence is not limited to any particular field of medicine, non-adherence occurs in approximately one-third to one-half of dermatological patients. Non-adherence is of importance as it is a significant cause of treatment failure, resulting in worse quality of life, worse health outcomes, and increased insurance costs.

详细描述

Unlike most modes of medication administration, topical medications do not have a standardized method of dosage administration] Although qualitative administration measures exist, these measures are often arbitrary and not quantifiable (i.e., "a fingertip"). In such cases, inappropriate dosing (i.e., using too much or too little) is an essential cause of treatment failure, and measurements of adherence for topical medications should consider the amount of medication administered. In a study analyzing the response to treatment in psoriatic patients, patients who received a standardized dose of topical calcipotriol achieved a more significant decrease in mean Psoriasis Area and Severity Index (PASI) (47%) compared to patients who were not standardized (17%, P<0.0001). Moreover, over two-thirds of psoriatic patients deemed initially poor responders in the standardized regimen group were considered responsive to treatment after further consideration.

Given topical options' low cost, efficacy, and excellent safety profiles, they are the first line treatment option for mild-to-moderate Atopic Dermatitis (AD) treatment. This study will aim to assess differences in the amount of medication dispensed in two groups of patients with atopic dermatitis. The first will undergo a brief educational demonstration by a trained professional to highlight the appropriate amount of topical medication to dispense for their disease involvement. The second group will be a control group and receive the same medication; however, the Participants will receive standard of care education (verbal and written instructions) only. Data from the two groups will be collected and analyzed to measure trends in dosing (i.e., if the correct dosage quantity and frequency was dispensed).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
9 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of skin dermatitis
  • Ability to return for a one-week clinical studies follow-up
  • Patients who are candidates for treatment with 0.1% triamcinolone ointment (even if they weren't in the study)
  • Adult or pediatric patients with active dermatitis who receive dermatologic care at Atrium Health Wake Forest Baptist, Department of Dermatology.

排除标准

  • Patients without the diagnosis of skin dermatitis
  • Inability to return for a one week follow up appointment
  • Body Surface Area (BSA) affected <2%

研究组 & 干预措施

Demonstration

Active Comparator

Observe a live demonstration instructing how to dispense 1 fingertip unit (FTU) of medication (triamcinolone cream) per 1% body surface area

干预措施: Demonstration of applying triamcinolone cream (Other)

Mobile Application

Experimental

Additional mobile application that provides instructions to apply the medication (triamcinolone cream)

干预措施: Mobile App Use (Behavioral)

Written/verbal instructions only

Other

Standard of care written/verbal instructions only

干预措施: Standard of Care (Other)

结局指标

主要结局

Amount of Topical Medication Dispensed - Standard of Care Group

时间窗: Day 7

Amount of Topical Medication Dispensed in grams

Amount of Topical Medication Dispensed - Demonstration Group

时间窗: Day 7

Amount of Topical Medication Dispensed in grams

Change in Percentage of Body Surface Area (BSA) affected

时间窗: Baseline and Day 7

Body Surface Area percentage = 0.007184 x (Height(cm)\^0.725) x (Weight(kg)\^0.425)

Amount of Topical Medication Dispensed - Mobile Application Group

时间窗: Day 7

Amount of Topical Medication Dispensed in grams

Number of times of Application - Demonstration Group

时间窗: Day 7

Frequency of Application

Change in Investigator Global Assessment (IGA) Scores

时间窗: Baseline and Day 7

The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 2 is mild, 3 is moderate, and 4 indicates severe AD. A decrease in score relates to an improvement in signs and symptoms.

Number of times of Application - Standard of Care Group

时间窗: Day 7

Frequency of Application

Number of times of Application - Mobile Application Group

时间窗: Day 7

Frequency of Application

Subject Questionnaire Scores

时间窗: Day 7

a brief questionnaire will be distributed to gain insight into attitudes towards medication samples and educational demonstrations.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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