Weekend Systemic Isotretinoin for Maintaining Acne Remission: A Novel Approach
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of acne relapse during maintenance phase
研究概览
简要总结
The goal of this study is to learn if isotretinoin oral tablets as a weekend regimen are safe and effective to maintain freedom from acne lesions in young adults who have completed a full course of isotretinoin on daily basis and achieved total control of the acne activity.
详细描述
Three groups of adult acne patients will be given a full course of isotretinoin with a cumulative dose of 120-150 mg/Kg weight in the 1st two groups, and till lesional clearance in the 3rd group with an additional month of maintenance. Afterwards, the 1st group will use adapalene gel every other day for maintenance, the 2nd and 3rd groups will use weekend oral isotretinoin. Patients will be followed for a year for reappearance of acne lesions, and safety of maintenance regimens. Patients opinion will be also sought.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The assessor responsible for the follow up (assessing primary and secondary measures) during the treatment and maintenance phases was blinded to the line of treatment used.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥ 18 years) with moderate to severe facial acne, as per the Investigator Global Assessment (IGA) scale
排除标准
- •patients on systemic acne medications in the past 3 months or topicals in the last month, pregnant or breastfeeding females, those with evidence of endocrine disturbances or using medications for comorbidities
研究组 & 干预措施
Adapalene group
Patients received full Isotretinoin course for treatment, and maintained on every other day adapalene gel.
干预措施: Isotretinoin capsules (Drug)
Full Iso group
Patients received full isotretinoin course for treatment, and maintained on weekend isotretinoin.
干预措施: Isotretinoin capsules (Drug)
Clearance Iso
Patients treated by systemic isotretinoin till full clearance and for a month thereafter, and maintained on weekend isotretinoin.
干预措施: Isotretinoin capsules (Drug)
结局指标
主要结局
Incidence of acne relapse during maintenance phase
时间窗: one year
percent of patients having one grade worsening of their acne investigator global assessment scale achieved by end of treatment phase as assessed by the physician during follow up
Maximum severity of acne relapse during follow up
时间窗: One year
Maximum investigator global assessment score reached by the the patient during the follow up year
Timing of acne relapse after initiating maintenance
时间窗: one year
The time interval between initiating maintenance and the occurrence of one grade worsening of the patient's investigator global assessment scale achieved by the end of treatment phase as assessed by the physician during follow up
Incidence of adverse effects
时间窗: One year
Percent of patients reporting adverse effects in general, percent of patients reporting each category of side effects, including disturbed lipid profile, raised transaminases, psychological changes, dryness, hair shedding, ...
次要结局
- Subjective convenience of maintenance regimen to patient(one year)
- subjective patient satisfaction by maintenance regimen(one year)
研究者
Carmen Ibrahim Farid
Professor of Dermatology, Venereology and Andrology
Alexandria University