Evaluation of Efficacy of Topical Flutamide in the Treatment of Acne Vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- changes in the number of comedones, papules, and pustules
研究概览
简要总结
From the obtained results, topical Flutamide 1% gel can be a promising, effective, and safe alternative in treating patients with acne vulgaris with minimal side effects.
详细描述
Flutamide is a non-steroidal anti-androgen, which is used to treat patients with prostate cancer. Due to its anti-androgenic properties can be used in cases of acne, hirsutism, and androgenic alopecia with successful outcomes. To minimize the unnecessary systemic side effects associated with the oral administration of Flutamide. It has been shown that the topical delivery of Flutamide can allow high drug levels at the site of action, decreasing the systemic side effects and improving patient compliance.
The Flutamide group received topical Flutamide 1% gel twice daily on the face for 8 weeks and the control group received the same gel components, without flutamide, twice daily on the face for 8 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fifty adult patients with acne having inflammatory (papules and pustules) and non-inflammatory (comedones) of different sizes, distribution, and durations were included in this study.
排除标准
- •Patients with a history of acne treatment with systemic or topical antibiotics, retinoids, or hormonal therapy within the last 3 months.
- •Patients with a history of chronic renal failure, hepatic insufficiency
研究组 & 干预措施
Group A (Flutamide group)
Flutamide was supplied in the form of yellow powder and obtained from Sigma Pharmaceutical Industries, Egypt.
Tween 80 and Propylene glycol were obtained from Sigma Pharmaceutical Industries, Egypt.
Oleic acid was purchased from El Gomhouria Company for Trading Chemicals and Medical Appliances, Egypt.
干预措施: Flutamide 1% gel (Drug)
Group B (control group)
Tween 80 and Propylene glycol were obtained from Sigma Pharmaceutical Industries, Egypt.
Oleic acid was purchased from El Gomhouria Company for Trading Chemicals and Medical Appliances, Egypt.
干预措施: topical gel without flutamide (Drug)
结局指标
主要结局
changes in the number of comedones, papules, and pustules
时间窗: up to 8 weeks
Response to treatment was evaluated by the changes in the number of comedones, papules, and pustules and by a photographic comparison taken at Baseline ( before treatment) and at 2,4,6, and 8 weeks at (termination of therapy).
次要结局
- side effects(8 weeks)
研究者
Reham Essam
Lecturer of Dermatology
Zagazig University