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