Efficacy and Safety of Oral Isotretinoin 10 mg, 20 mg and 30 mg for the Treatment of Facial Recalcitrant Flat Warts at Centro Dermatológico "Dr. Ladislao de la Pascua": Randomized Double-blinded Clinical Trial of Three Arms
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Complete clearance
研究概览
简要总结
Randomized clinical trial to compare the efficacy of different doses of oral isotretinoin 10 mg/day, 20 mg/day and 30 mg/day during 12 weeks for the treatment of facial recalcitrant flat warts. The primary endpoint will be the proportion of participants with total remission of facial flat warts at the end of the intervention in the three arms of the clinical trial.
详细描述
The investigators will recruit 162 participants with facial recalcitrant flat warts and randomize to the following three arms of intervention: Arm 1: nne capsule of isotretinoin 10 mg plus one capsule of placebo, per day during 12 weeks; Arm 2: one capsule of isotretinoin 20 mg plus one capsule of placebo, per day during 12 weeks; and Arm 3: one capsule of isotretinoin 10 mg plus one capsule of isotretinoin 20 mg, per day during 12 weeks. The primary endpoints will be the proportion of participants with total remission of facial flat warts at the end of the intervention in the three arms of the clinical trial; and the incidence of side effects related to oral isotretinoin treatment among the 3 arms of treatment.
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 (Participant, Outcomes Assessor)
盲法说明
All the interventions will be similar in appearance and all the participants will take the same quantity of capsules.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and histological diagnosis of facial flats warts
- •More than 2 years with facial flat warts
- •Without response to 2 or more topical interventions (tretinoin, imiquimod, cryosurgery and 5-fluorouracil) or oral interventions (cimetidine or zinc sulfate)
排除标准
- •Have the following conditions:
- •Hypercholesterolemia
- •Hypertriglyceridemia
- •Liver disease
- •Renal disease
- •Sjögren syndrome
- •Depressive disorder
- •Body mass index less than 18 points or higher than 25 points
- •Contraindications for hormonal contraception or intrauterine device.
研究组 & 干预措施
Isotretinoin 10 mg/day
One capsule of isotretinoin 10 mg plus one capsule of placebo, per day during 12 weeks.
干预措施: Isotretinoin capsules (Drug)
Isotretinoin 20 mg/day
One capsule of isotretinoin 20 mg plus one capsule of placebo, per day during 12 weeks.
干预措施: Isotretinoin capsules (Drug)
Isotretinoin 30 mg/day
One capsule of isotretinoin 10 mg plus one capsule of isotretinoin 20 mg, per day during 12 weeks.
干预措施: Isotretinoin capsules (Drug)
结局指标
主要结局
Complete clearance
时间窗: 12 weeks
Proportion of participants with total remission of facial flat warts at the end of the intervention in the three arms of the clinical trial.
Incidence of serious adverse events
时间窗: 12 weeks
Proportion of participants that developed a serious side effect in the three arms during the clinical trial.
次要结局
- Quality of life index(12 weeks)
- Adherence to intervention(12 weeks)