Study Assessing the Effect of Chocolate Consumption in Subjects With A History of Acne Vulgaris (NCT01193764) | Clinical Trial Compass
TerminatedNot Applicable
Study Assessing the Effect of Chocolate Consumption in Subjects With A History of Acne Vulgaris
United States14 participantsStarted 2010-09
Plain-language summary
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.
Who can participate
Age range
18 Years – 35 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.