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

Acne research study

What is the primary objective of this study?

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 is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Acne

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Dietary Supplement:100% cocoa powderA single-center, prospective, double blind, placebo controlled study will be conducted in which male subjects with very mild acne swallow capsules filled with either unsweetened 100% cocoa (Ghirardelli), hydrolyzed gelatin powder (Gelita), or a combination of the two, at baseline. The study team will fill the capsules with either 6 oz. of hydrolyzed gelatin, 6 oz. cocoa powder (Ghirardelli ©), or a 6 oz. combination of cocoa powder (Ghirardelli ©) and hydrolyzed gelatin, totaling 6oz using a capsule encapsulation sheet (holding 60 capsules that need to be filled each time). All subjects will ingest the same number of total capsules. Evaluations will be performed using clinical assessments 4 days and 7 days after baseline evaluations (+/- 1 days).

Dietary Supplement:gelatin (Gelita)A single-center, prospective, double blind, placebo controlled study will be conducted in which male subjects with very mild acne swallow capsules filled with either unsweetened 100% cocoa (Ghirardelli), hydrolyzed gelatin powder (Gelita), or a combination of the two, at baseline. The study team will fill the capsules with either 6 oz. of hydrolyzed gelatin, 6 oz. cocoa powder (Ghirardelli ©), or a 6 oz. combination of cocoa powder (Ghirardelli ©) and hydrolyzed gelatin, totaling 6oz using a capsule encapsulation sheet (holding 60 capsules that need to be filled each time). All subjects will ingest the same number of total capsules. Evaluations will be performed using clinical assessments 4 days and 7 days after baseline evaluations (+/- 1 days).

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

cocoaunsweetened 100% cocoa (Ghirardelli)

placebohydrolyzed gelatin powder (Gelita)

Study Status

Unknown status

Start Date: September 2010

Completed Date: March 2011

Phase: N/A

Type: Interventional

Design:

Primary Outcome: development of acneiform lesions

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Samantha Block, B.S.

Lead Sponsor: University of Miami

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01193764

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