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临床试验/NCT00964119
NCT00964119终止不适用

An Interdisciplinary Study of Musculoskeletal Effects of Isotretinoin During Acne Treatment in Pediatric Population

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2008年7月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
15
试验地点
1
主要终点
Skeletal Toxicities Related to the Use of Isotretinoin

研究概览

简要总结

This is a prospective study, that will follow participants over their course of treatment on Isotretinoin. All patients who are prescribed Isotretinoin for their acne treatment are registered in iPLEDGE. The iPLEDGE program involves a set of steps that the patient, physician and pharmacist must follow for the patient to take Isotretinoin. Patients will be asked if they are willing to participate in this research study to determine musculoskeletal changes in adolescents and young adults on systemic therapy using the highly sensitive magnetic resonance (MR) imaging modality. In addition to the MRI, participants will be asked if they are willing to give an extra sample of blood when their routine blood work is being done for iPLEDGE. This blood sample will be used to determine if there are any effects of isotretinoin on bone turnover markers.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
12 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Registered in I-Pledge and has not started the Isotretinoin medication
  • •Females and males ages 12-21 years old
  • •Able to undergo 3 MRI scan

排除标准

  • •Participants taking additional vitamin A, D or Calcium supplements
  • •Previous musculoskeletal injuries (from incidental trauma, sports related injury or motorvehicle accidents, etc)
  • •Clinical diagnosis of psoriasis, rheumatoid arthritis and/or Reiter's disease
  • •relocation within the next 6 months
  • •participation on a research study involving drug medication within the past 30 days

结局指标

主要结局

Skeletal Toxicities Related to the Use of Isotretinoin

时间窗: Baseline to 5 months post therapy

Bone Marker measurements to assess skeletal toxicities: Change in Bone specific Alkaline Phosphatase: (BSAP) over 5 months of therapy

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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