Study to Evaluate Resistant Disease/Max Adherence to Topical Treatments in Patients With Atopic Dermatitis and Psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Investigator Global Assessment- Atopic Dermatitis
研究概览
简要总结
Psoriasis and atopic dermatitis are chronic inflammatory disease that account for a significant amount of patients in most dermatological practices. Topical corticosteroid agents are often prescribed for treatment of both these conditions, especially when they are localized rather than wide spread. The development of resistance to treatment is termed tachyphylaxis. Poor adherence, rather than down regulation of receptors, may be the primary cause of tachyphylaxis to topical corticosteroids. The primary objective of the study is to determine, under conditions designed to assure good adherence, whether topical 0.25% desoximetasone spray improves clinical outcomes in patients who have resistant inflammatory skin disease defined by failure of previous topical steroid treatment.
详细描述
Psoriasis and atopic dermatitis are chronic inflammatory disease that account for a significant amount of patients in most dermatological practices. Topical corticosteroid agents are often prescribed for treatment of both these conditions, especially when they are localized rather than wide spread. Prolonged treatment with corticosteroids occasionally results in resistance to treatment. The development of resistance to treatment is termed tachyphylaxis. Tachyphylaxis has been thought to be a result of down regulation of target receptors, resulting is a decreased metabolic effect of the compound.
Poor adherence, rather than down regulation of receptors, may be the primary cause of tachyphylaxis to topical corticosteroids. Patients' use of topical medications decrease over time. Topical spray vehicles have become increasingly more popular because of their rapid application and ease of use. Desoximetasone 0.25% spray is a well-tolerated, FDA approved, potent topical corticosteroid that rapidly and successfully treats inflammatory skin diseases.
Lots of treatment options exist for psoriasis; however, some patients do not get better using these medications. These patients are said to have resistant disease. In this study, we define resistant disease by failure of previous topical steroid treatment. Poor adherence is a barrier to positive clinical outcomes. Failure to respond to medication may be a result of poor adherence rather than resistance to the topical therapy. The purpose of this study is to delineate between the two.
The primary objective of the study is to determine, under conditions designed to assure good adherence, whether topical 0.25% desoximetasone spray improves clinical outcomes in patients who have resistant inflammatory skin disease defined by failure of previous topical steroid treatment.
We propose to enroll 12 subjects with psoriasis and 12 subjects with atopic dermatitis who have "failed" previous topical treatment. Subjects will be required to have body surface area involvement that can be reasonably treated with topical treatment. At the baseline visit, patients will be given Topicort spray and will be shown how to use it. Patients will apply the medication at the initial visit under supervision. Subjects with atopic dermatitis will be treated for 1 week; subjects with psoriasis will be treated for 2 weeks. Visits will take place at baseline, 3 days, 1 week, and in the case of psoriasis, 2 weeks. All subjects enrolled in the study will receive nominal compensation per visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Male or female ≥18 years of age at baseline visit.
- •Documentation of plaque-type psoriasis or atopic dermatitis diagnosis as evidenced by one or more clinical features
- •Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
排除标准
- •Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- •No access to a phone throughout the day
- •Subject is diagnosed with a disease that is known to effect adherence and would otherwise bias our results (Such as Alzheimer's or dementia)
- •Patient had a history of allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance that, in the opinion of the Investigator, would compromise the safety of the patient or the results of the study.
研究组 & 干预措施
Control- Atopic Dermatitis
Participants with atopic dermatitis will receive desoximetasone and no calls.
干预措施: Desoximetasone 0.25% spray (Drug)
Atopic Dermatitis Intervention
Participants with atopic dermatitis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.
干预措施: Phone calls (Behavioral)
Atopic Dermatitis Intervention
Participants with atopic dermatitis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.
干预措施: Desoximetasone 0.25% spray (Drug)
Control- Psoriasis
Participants with psoriasis will receive desoximetasone and no calls.
干预措施: Desoximetasone 0.25% spray (Drug)
Psoriasis Intervention
Participants with psoriasis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.
干预措施: Phone calls (Behavioral)
Psoriasis Intervention
Participants with psoriasis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.
干预措施: Desoximetasone 0.25% spray (Drug)
结局指标
主要结局
Investigator Global Assessment- Atopic Dermatitis
时间窗: 1 week
Investigator's Global Assessment of atopic dermatitis integrates all lesions for overall score. This measure is commonly used to quantify disease severity and most resembles assessments performed in the clinic setting. Score ranges from '0' = Clear to '5' = Very Severe Disease
Investigator Global Assessment- Psoriasis
时间窗: 2 weeks
Investigator's Global Assessment of atopic dermatitis integrates all lesions for overall score. This measure is commonly used to quantify disease severity and most resembles assessments performed in the clinic setting. Score ranges from '0' = Clear to '5' = Very Severe Disease
次要结局
- Total Lesion Severity Score- Atopic Dermatitis(1 week)
- Total Lesion Severity Score-Psoriasis(2 weeks)
- Eczema Area and Severity Index- Atopic Dermatitis(1 week)
- Pruritus Visual Analog Scale- Atopic Dermatitis(1 week)
- Pruritus Visual Analog Scale- Psoriasis(2 weeks)
- Psoriasis Area and Severity Index(2 weeks)