Double Blind Placebo Controlled Study Assessing the Effect of Chocolate Consumption in Subjects With A History of Acne Vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Number of acneiform lesions
研究概览
简要总结
The investigators conducted a recent pilot study and found a strong positive correlation between the consumption of 100% chocolate and acne exacerbation. However, this study had limitations including the lack of placebo and the small sample size. Although studies have been conducted assessing chocolate's effect on acne, no study has been done evaluating this effect using chocolate with 100% cocoa content in a double blind placebo controlled fashion. This study will analyze the difference in the number and type of acneiform lesions per subject at the different time points (Day 4 and Day 7) compared to baseline in order to increase the validity of the investigators results. In addition, the investigators will use unsweetened cocoa powder,12 rather than chocolate candy, which contains higher quantities of additive ingredients such as sugar and milk to avoid interference with the results and the possibility to establish or not an association between the unsweetened cocoa and an effect on acne.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Post-pubescent males between the ages of 18-35 with minimal facial acne lesions defined as no less than 1 comedone and/or papule and no more than 8 total comedones and papules at Screening/Baseline
- •Subjects who have no more than 2 papules at baseline
- •Subjects who have no facial pustules at Screening/Baseline
- •Subjects who have a history of facial acne vulgaris
- •Subjects with a score of 0 or 1 on the investigator's Global Assessment Scale (See Appendix A)
- •Subjects must sign an informed consent form
- •Subjects must remain in the South Florida area during the study
- •Volunteers in general good health
- •Volunteers on no over the counter or prescribed medication, including supplements
- •Subjects must be literate in the English language
排除标准
- •Subjects of the female gender
- •Subjects with a history of diabetes mellitus
- •Subjects who have had allergic reactions to cocoa or gelatin
- •Subjects who have more than 8 total comedones and papules at Screening/Baseline
- •Subjects who have more than 2 papules at screening/baseline
- •Subjects who have one or more pustules and/or nodules at Screening/Baseline
- •Subjects with a history of taking anti-acne oral medication (i.e. isotretinoine) during the past six months
- •Subjects who have used any oral antibiotics in the past two weeks
- •Subjects currently applying any over-the-counter or prescribed anti-acne medication including, but not limited to, retinoic acid or benzoyl peroxide over the past six weeks
- •Subjects who have used facial topical or injectable steroids 6 weeks prior to screening/baseline and during the study
- •Subjects currently taking any over-the-counter or prescribed medication including but not limited to oral supplements, vitamin A, etc. over the past two weeks
- •Subjects who used systemic corticosteroids 6 weeks prior to screening/baseline or during the study
- •Subjects taking drugs known to be photosensitizers including, but not limited to, phenothiazines, amiodarone, quinine, thiazides, tetracyclines, sulphonamides, quinolones
- •Subjects who are expected to have excess sun exposure during the study
- •Subjects who will not be in the South Florida area during the study
- •Subjects who are diagnosed with obesity with a BMI of 30 or greater
- •Subjects who have a history of hypertriglyceridemia
研究组 & 干预措施
cocoa
unsweetened 100% cocoa (Ghirardelli)
干预措施: 100% cocoa powder (Dietary Supplement)
placebo
hydrolyzed gelatin powder (Gelita)
干预措施: gelatin (Gelita) (Dietary Supplement)
结局指标
主要结局
Number of acneiform lesions
时间窗: 7 days
Number of lesions counted.
次要结局
未报告次要终点
研究者
Robert S. Kirsner
Professor
University of Miami