Innate Immunity in Acne Vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Lesion Counts (Total, Inflammatory and Non-inflammatory)
研究概览
简要总结
The purpose of this study is to study the effects of topical Vitamin D cream (Calcipotriene, also known as Dovonex) on acne. The information gained from this study may lead to new treatments for acne. In this study, Calcipotriene will be compared with a placebo, a cream that looks like Calcipotriene, but contains no active ingredients.
详细描述
This study will be a randomized, double-blinded, parallel group comparison of calcipotriene vs. placebo cream. Patients with acne will use calcipotriene or placebo cream 2x/day for 12 weeks and will be assessed at weeks 0, 2, 4, 8 and 12. Each group will have 24 subjects as calculated by power analysis. Three additional subjects for each group will be recruited for possible dropouts and total of 27 subjects will be recruited for each group. Primary endpoint (lesion count) and secondary endpoint (IGA- Investigator's Global Assessment) will be determined. Lesion counts will be assessed by one of the investigator physicians or nurse practitioner. Adverse effects including irritation, dry skin, inflammation and worsening of the lesions will be noted at each visit. Photographs will be taken to aid in assessing the clinical changes.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older, of either gender and any racial/ethnic group
- •Subjects must have clinically evident mild to moderate acne vulgaris of the facial area, IGA scale, grade 2-4
- •Subjects must understand and sign the informed consent prior to participation
- •Subjects must be in generally good health
- •Subjects must be able and willing to comply with the requirements of the protocol
排除标准
- •Oral retinoid use within twelve months of entry into the study
- •Systemic acne therapies (oral antibiotics) within 30 days of entry into the study
- •Topical acne therapies (retinoids, antibiotics) within 14 days of entry into the study
- •Non-compliant patients
- •Pregnant or nursing women
- •Subjects with a significant medical history or concurrent condition that the investigator(s) feel is not safe for study participation
- •Subjects with hypercalcemia (hyperparathyroidism, kidney disease)
- •Subjects who cannot avoid excessive exposure to either natural or artificial sunlight.
研究组 & 干预措施
Calcipotriene Cream
The Calcipotriene Cream will be supplied as 1g daily use individual tubes to be used 2x/day (once in the morning and once in the evening) for 12 weeks.
干预措施: Calcipotriene (Drug)
Placebo
The Placebo Cream will be supplied as 1g daily use individual tubes to be used 2x/day (once in the morning and once in the evening) for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Lesion Counts (Total, Inflammatory and Non-inflammatory)
时间窗: Weeks 2, 4, 8 & 12
Lesion counts will be assessed by one of the investigator physicians or nurse practitioner.
次要结局
- Acne Severity as Assessed With the Investigator's Global Assessment (IGA)(Weeks 2, 4, 8 & 12)
研究者
Jenny Kim, MD, PhD
Professor of Medicine/Dermatology
University of California, Los Angeles