Efficacy and Tolerability of Nicotinamide Plus Cream for Moderate Acne Vulgaris in Indonesia: A Multicenter Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 125
- 主要终点
- inflammatory and non-inflammatory acne lesion reduction number analyzed using GLMM
研究概览
简要总结
Acne vulgaris (AV) is a chronic inflammatory disease of the pilosebaceous unit that affects seborrheic areas such as the face, back and chest. AV is characterized by blackheads, papules, pustules nodes and cysts with sequelae of hyperpigmentation and scarring. It is one of the most common skin disorders treated by dermatologists. Acne vulgaris can be found at any age, although it is more frequent in teenagers and young adults. The prevalence of AV in a population of 11 to 30 years old is approximately 80%. Due to its involvement of the face, it is considered to be a cosmetic problem, thus bearing a psychosocial burden.
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, Care Provider)
入排标准
- 年龄范围
- 12 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •moderate acne vulgaris
- •12 and up to 50 years old,
- •agreed to become research participants and has signed the informed consent.
排除标准
- 未提供
研究组 & 干预措施
Adapalene and placebo (ADAP)
干预措施: Adapalene (Drug)
Adapalene and placebo (ADAP)
干预措施: Placebos (Drug)
Adapalene, Nicotinamide, ABA, Zinc PCA (ANAZ)
干预措施: Adapalene (Drug)
Adapalene, Nicotinamide, ABA, Zinc PCA (ANAZ)
干预措施: Nicotinamide, ABA and Zinc PCA (Drug)
结局指标
主要结局
inflammatory and non-inflammatory acne lesion reduction number analyzed using GLMM
时间窗: 6 weeks
objective evaluation was based on photographs of participants from three angles per visit. The outcome of efficacy was measured from the percentage reduction of inflammatory and non-inflammatory lesions number and analyzed using the GLMM (General Linear mixed Model)
次要结局
未报告次要终点
研究者
Dr Irma Bernadette S Sitohang
Medical Doctor
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto