Study Assessing the Effect of Chocolate Consumption in Subjects With A History of Acne Vulgaris

University of Miami

Status

Terminated

Conditions

Acne

Treatments

Dietary Supplement: 100% cocoa powder

Dietary Supplement: gelatin (Gelita)

Study type

Interventional

Funder types

Other

Identifiers

NCT01193764

20100520

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

Male

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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 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