Evaluating the Effect of Isotretinoin in Regulatory T-cell Function in Adverse Cutaneous Drug Eruptions (ACDEs): A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of days of hospitalization
研究概览
简要总结
The purpose of this study is to determine whether isotretinoin is helpful in treating patients with an adverse cutaneous drug eruption known as toxic epidermal necrolysis (TEN).
详细描述
Toxic epidermal necrolysis (TEN) is a potentially life-threatening skin disorder characterized by widespread redness, blistering and peeling of skin.
Currently, supportive care in the standard treatment for patients with TEN. Isotretinoin, an FDA-approved medication commonly used for treating severe acne induces differentiation of certain inflammatory cells and thus may potentially be helpful in treating patients with TEN.
This is a randomized, placebo-controlled, double-blind, pilot study comparing the efficacy and safety of isotretinoin versus placebo in treating subjects with toxic epidermal necrolysis (TEN).
Approximately 40 subjects who satisfy all inclusion and exclusion criteria will be randomly assigned in a 1:1 ratio to either isotretinoin or placebo which they will take for up to 14 days. The end of the study is defined as the time the subject is discharged from the hospital. Participants will primarily be assessed for percent body surface affected (BSA) and number of days of hospitalization.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 69 years of age
- •Has biopsy-proven toxic epidermal necrolysis (TEN)
- •If female, should not be of childbearing potential defined as:
- •Have not had menstrual periods for 12 months in a row (menopause) OR
- •Had bilateral oophorectomy or total hysterectomy OR
- •Have a ovarian disorder that would make pregnancy not possible
排除标准
- •Unknown HIV status and unwilling to undergo HIV testing
- •Women of childbearing potential
- •Breastfeeding
- •Fasting serum triglyceride levels >25% of upper limit of normal
- •Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase levels >2× upper limit of normal (ULN)
- •Known allergy to isotretinoin
- •History of suicidal attempt, psychosis, major depression or other serious mood disorders
- •Currently taking vitamin A supplements, tetracyclines, phenytoin, corticosteroids, IVIg or St. John's Wort
- •Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
- •Participation in an interventional study within the past 30 days.
研究组 & 干预措施
Isotretinoin
Isotretinoin will be given at the following dosage:
Dosing will be as listed on the table below.
Weight in Kg Total Daily Dose 40-49 Kg 40mg 50-89 Kg 80mg 90-150 Kg 120mg
干预措施: Isotretinoin (Drug)
Placebo
Subjects will be given placebo capsules twice a day.
干预措施: Placebo (Other)
结局指标
主要结局
Number of days of hospitalization
时间窗: up to 14 days
Number of days patient will be hospitalized.
次要结局
- Percent of body surface affected (BSA)(up to 14 days)