A Double Blind Randomised Comparison of Nadifloxacin 1% Cream Alone and Nadifloxacine %1 Cream With Benzoyl Peroxide 5% Solution in the Treatment of Mild to Moderate Facial Acne Vulgaris
试验速览
- 阶段
- 3 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Number of patients whom inflammatory lesions were decreased %50 or more
研究概览
简要总结
The purpose of this study is to determine whether using of nadifloxacine 1% cream and benzoyl peroxide 5% solution together is more effective than using nadifloxacine alone in the treatment of mild to moderate facial acne.
详细描述
Nadifloxacin; a new topical antibiotic for the treatment of acne has recently been marketed in our country. Only a few studies on its use and effectiviness could be found in the literature. Nadifloxacin may be an alternative to other topical antibiotics and benzoyl peroxide or its use along with benzoyl peroxide may be more effective and rational to prevent possible future resistance.
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, Investigator)
入排标准
- 年龄范围
- 14 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of mild to moderate facial acne vulgaris
- •Must have at least 10 inflammatory and/or non-inflammatory and no more than 3 nodulocystic acne lesions
排除标准
- •Nodulocystic acne lesions more than 3 and pure comedonal acne
- •Additional truncal acne needs systemic therapy
- •Usage of topical treatments for acne in last 2 weeks, systemic antibiotic in last 4 weeks, systemic isotretinoin in last 6 months
- •Application of chemical peels and laser in last 4 weeks
- •Usage of hormones in last 3 months
- •Clinical signs of hyperandrogenism in females
- •Pregrancy and lactation
- •Hypersensitivity to interventions
- •Additional facial skin diseases (eg. atopic and seborreic dermatitis)
- •Photosensitive disorders and usage of drugs which can trigger Photosensitive conditions
研究组 & 干预措施
A
instructed nadifloxacine 1% cream twice dailly, and placebo for benzoyl peroxide 5% solution once dailly
干预措施: nadifloxacine (Drug)
B
instructed nadifloxacine 1% cream twice dailly, and active benzoyl peroxide 5% solution once dailly
干预措施: benzoyl peroxide (Drug)
B
instructed nadifloxacine 1% cream twice dailly, and active benzoyl peroxide 5% solution once dailly
干预措施: nadifloxacine (Drug)
结局指标
主要结局
Number of patients whom inflammatory lesions were decreased %50 or more
时间窗: two months
次要结局
- the number of patients whom were observed side effects(two months)