CTRI/2024/07/071250尚未招募2 期
A study to evaluate the efficacy and safety of microbotox versus oral isotretinoin therapy in treating seborrhea and acne-A randomized controlled pilot study.
Aishwarya Satyanarayana1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月30日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in the subjective seborrhea severity graded on a scale of 1 to 10, 1 being mild and 10 being severe from baseline to 3 months.
研究概览
简要总结
This is a randomized controlled study comparing the efficacy and safety of microbotox injection versus oral isotretinoin in treating acne and seborrhea. The study will include 15 patients in each treatment arm. The follow up will be at baseline, 4, 8 and 12 weeks. The outcome measures assessed will be reduction the severity of seborrhea and acne and adverse effects of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients above the age of 18 years, with seborrhea which meets the criteria as per skin oiliness and acne which requires isotretinoin therapy.
- •Patients who are willing to provide informed consent will be considered for participation in the study.
排除标准
- •Patients with active infection at injection site, neuromuscular disorders, known hypersensitivity to any ingredient of the injection.
- •Pregnant and lactating women.
- •Patients on oral steroid therapy, anticoagulant therapy, systemic retinoid intake in the previous six months.
- •Patients with unrealistic expectations.
结局指标
主要结局
Reduction in the subjective seborrhea severity graded on a scale of 1 to 10, 1 being mild and 10 being severe from baseline to 3 months.
时间窗: Reduction in the subjective seborrhea severity at baseline, 4weeks, 8weeks and 12weeks.
次要结局
- Reduction in the Comprehensive Acne Severity Score from baseline to 3 months.(Baseline at 0weeks, follow up visits at 4,8,12 weeks.)
研究者
Aishwarya Satyanarayana
Bangalore medical college and research institute, Bangalore
研究点 (1)
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