Effect of Oral Isotretinoin on Muscle Strength in Patients With Acne Vulgaris: A Prospective Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The hamstring and quadriceps muscle strengths of the non-dominant lower extremity
研究概览
简要总结
BACKGROUND: Musculoskeletal side effects related to isotretinoin are frequently reported. This study aimed to investigate the effect of oral isotretinoin treatment on muscle strength. Our second aim was to evaluate whether there was a correlation between the serum creatine phosphokinase (CPK) level, a specific marker of muscle breakdown, and muscle strength.
METHODS: This study included 30 patients who presented to our hospital and were started on oral isotretinoin treatment for acne vulgaris and 30 patients in the control group who were given local treatment. Age, gender, height and weight of the patients were recorded, and the body mass index (BMI) was calculated. The hamstring and quadriceps muscle strengths of the non-dominant side were evaluated in all patients using an isokinetic dynamometer, and the peak torque (PT) values were recorded. In the isotretinoin group, isokinetic measurements were performed again in those that completed six-month drug treatment and compared with the initial PT values.
详细描述
BACKGROUND: Musculoskeletal side effects related to isotretinoin are frequently reported. This study aimed to investigate the effect of oral isotretinoin treatment on muscle strength. Our second aim was to evaluate whether there was a correlation between the serum creatine phosphokinase (CPK) level, a specific marker of muscle breakdown, and muscle strength.
METHODS: This study included 30 patients who presented to our hospital and were started on oral isotretinoin treatment for acne vulgaris and 30 patients in the control group who were given local treatment. Age, gender, height and weight of the patients were recorded, and the body mass index (BMI) was calculated. The hamstring and quadriceps muscle strengths of the non-dominant side were evaluated in all patients using an isokinetic dynamometer, and the peak torque (PT) values were recorded. In the isotretinoin group, isokinetic measurements were performed again in those that completed six-month drug treatment and compared with the initial PT values.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •being aged 18-45 years
- •receiving isotretinoin treatment for the isotretinoin group
- •not having used isotretinoin within the last year for the control group
排除标准
- •chronic kidney or liver disease,
- •uncontrolled hypertension, heart failure,
- •malignancy,
- •thyroid and bone diseases (e.g., hyperparathyroidism and osteomalacia),
- •use of drugs that may affect skeletal metabolism (e.g., corticosteroids, heparin, and anticonvulsants),
- •a history of trauma and/or surgery in the lower extremities.
- •Patients who discontinued or terminated their isotretinoin treatment were not included in the study.
结局指标
主要结局
The hamstring and quadriceps muscle strengths of the non-dominant lower extremity
时间窗: 6 months
peak torque values
creatinine phosphokinase
时间窗: 6 months
serum creatinine phosphokinase level
次要结局
未报告次要终点
研究者
Cevriye Mülkoğlu
Medical Doctor in Department of Physical Medicine and Rehabilitation
Ankara Training and Research Hospital