A Randomized, Double-Blind, Placebo-Controlled Trial To Determine The Safety and Efficacy of Lactoferrin With Vitamin E and Zinc as an Oral Therapy for Mild to Moderate Hormonal Acne in Adult Women
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Mean percentage change in inflammatory acne lesions at 2, 4, 6, 8, 10, and 12 weeks compared to baseline, in the treatment versus placebo groups
研究概览
简要总结
We previously showed that twice daily intake of a combination of 100 mg lactoferrin, 11 IU vitamin E, and 5 mg zinc significantly reduced both inflammatory and non-inflammatory acne lesions compared to placebo control. In that study, females showed an overall better response compared to males in terms of total lesions. We speculated that the gender effect may be due to mitigation of the pre- menstrual flare-ups women have that lead to recurring acne, making them have a better response. The objectives of this study are: 1.) to characterize the efficacy and safety of 100 mg lactoferrin + 11 IU vitamin E + 5 mg zinc in the adult female population who suffer from hormonal acne, 2.) to determine whether the anti-acne effect is maintained after treatment stops.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females aged 22-
- •At least 3 inflammatory acne lesions, mostly found on (but not limited to) the lower face
- •Not responsive to conventional treatment
- •Clinical diagnosis of mild to moderate acne according to Lehmann et. al.
排除标准
- •Females who are pregnant (confirmed by a pregnancy test), breast- feeding, or planning a pregnancy.
- •Post-menopausal women
- •Current or recent (within 3 months) use of any topical or oral anti- acne products,
- •Hormonal contraceptive intake in the preceding six months
- •A cancer diagnosis within the past 5 years
- •History of hypersensitivity to any component of the test product.
- •Current imuunosuppression. Specifically, these include patients with co-morbidities such as diabetes, HIV, chronic diseases patients requiring maintenance medications, such as vascular disease,
- •hepatitis, eczema, psoriasis, or acute febrile/infectious illnesses
- •(i.e. Dengue, pneumonia, etc)
结局指标
主要结局
Mean percentage change in inflammatory acne lesions at 2, 4, 6, 8, 10, and 12 weeks compared to baseline, in the treatment versus placebo groups
时间窗: 12 weeks
次要结局
- Mean percent change in the AFAST scores at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 weeks compared to baseline, in the treatment versus placebo groups(24 weeks)
- Percentage change in inflammatory acne lesion counts at 14, 16, 18, 20, 22, and 24 weeks compared to baseline(24 weeks)