Effects of Isotretinoin on the Morphology, Growth Rate, and Thickness of the Nail Plate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The effect of group on the change in growth rate of nail plate by time
研究概览
简要总结
The nail is an important skin appendage which can provide information about the person's overall health status in addition to having several important functions such as protection, tactile sensation, grasping. Many nail abnormalities which can have considerable psychological impact are side effects of drug administration. Retinoids have various effects on nails. Although isotretinoin as a retinoid has been associated with both decreased and increased nail growth, the great majority of such associations are not evidence-based. So, it was aimed to investigate the effects of isotretinoin on morphology, growth rate, and thickness of the nail plate.
详细描述
Isotretinoin has various side effects that affect many organ systems. Some side effects such as nail changes, which do not require treatment cessation, can limit the use of isotretinoin by impairing the patient's quality of life. Although it is known that isotretinoin has various effects on the nails, there is very limited data on effects of isotretinoin on the nails. Therefore, it was aimed to investigate the effect of isotretinoin on the morphology, growth rate, and thickness of the nail plate. The patients aged 18-45 that were planned to begin treatment with isotretinoin for acne in the outpatient clinic and a control group consisting of healthy volunteers are planned to be included in the study. A dermatological examination of skin and nails is conducted in all participants. Isotretinoin treatment at 0.5 mg/kg per day in 2 divided doses will be started to patients with acne. The length and thickness of nail plate are measured by digital caliper before isotretinoin treatment, and repeated during the control visits of the participants at 30 day intervals for 6 months. All the examination and measurements are carried out in both groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patients that were planned to begin treatment with isotretinoin for acne
排除标准
- •Having known diseases (dermatological or systemic disorders) affecting the growth rate and thickness of nail plate
- •Using systemic or topical drugs with known effects on nail
- •Having traumatic nail abnormalities (onychotillomania, nail biting, habit-tic deformity)
- •Having no visible lunula
- •Describing any trauma (including cutting or filing nails) between the two measurements
研究组 & 干预措施
isotretinoin
The patients aged 18-45 that were planned to begin treatment with isotretinoin for acne
干预措施: Isotretinoin (Drug)
结局指标
主要结局
The effect of group on the change in growth rate of nail plate by time
时间窗: 30 days
It is investigated using repeated measures analysis of variance
The lengths and thicknesses of nail plate according to months in the isotretinoin group
时间窗: 30 days
These are the measures of monthly nail growth rates and thicknesses of nail plate. The lengths and thicknesses of nail plate are recorded in millimeters. Results are presented as mean or median according to whether they are normally distributed or not.
The effect of group on the change in thickness of nail plate by time
时间窗: 30 days
It is investigated using repeated measures analysis of variance
The lengths and thicknesses of nail plate according to months in the control group
时间窗: 30 days
These are the measures of monthly nail growth rates and thicknesses of nail plate. The lengths and thicknesses of nail plate are recorded in millimeters. Results are presented as mean or median according to whether they are normally distributed or not.
Changes in nail growth rates by time in the isotretinoin group
时间窗: 30 days
It is investigated using repeated measures analysis of variance
Changes in nail thickness by time in the isotretinoin group
时间窗: 30 days
It is investigated using repeated measures analysis of variance
Comparison of nail growth rate according to groups
时间窗: 30 days
This is the comparison of monthly nail growth rates according to groups. The values of nail growth rates are recorded in millimeters per month.
Comparison of nail thickness according to groups
时间窗: 30 days
This is the comparison of monthly nail thickness according to groups. The values of nail thickness are recorded in millimeters.
次要结局
未报告次要终点
研究者
Sinan Özçelik
Assistant Professor
Balikesir University