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

NCT ID: NCT01193764

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-07-31

Brief 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.

Conditions

Acne

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

cocoa

unsweetened 100% cocoa (Ghirardelli)

Group Type: EXPERIMENTAL

100% cocoa powder

Intervention Type: DIETARY_SUPPLEMENT

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).

placebo

hydrolyzed gelatin powder (Gelita)

Group Type: PLACEBO_COMPARATOR

gelatin (Gelita)

Intervention Type: DIETARY_SUPPLEMENT

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).

Interventions

100% cocoa powder

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).

Intervention Type: 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).

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

100% cocoa powder (Ghirardelli ©); blue and white gelatin capsules (Capsuline); hydrolyzed gelatin (Gelita); blue and white gelatin capsules (Capsuline)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Robert S. Kirsner

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samantha Block, B.S.

Role: STUDY_DIRECTOR

University of Miami

Brian Berman, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Caroline Caperton, M.D., M.S.P.H.

Role: STUDY_CHAIR

University of Miami

Whitney Valins, B.S.

Role: STUDY_CHAIR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

20100520

Identifier Type: -

Identifier Source: org_study_id