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

February 18, 2019 updated by: Robert S. Kirsner, University of Miami

Double Blind Placebo Controlled Study Assessing the Effect of Chocolate Consumption in Subjects With A History of Acne Vulgaris

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: cocoa
unsweetened 100% cocoa (Ghirardelli)
Dietary supplement: 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).
Other Names:
  • 100% cocoa powder (Ghirardelli ©)
  • blue and white gelatin capsules (Capsuline)
PLACEBO_COMPARATOR: placebo
hydrolyzed gelatin powder (Gelita)
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).
Other Names:
  • blue and white gelatin capsules (Capsuline)
  • hydrolyzed gelatin (Gelita)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of acneiform lesions
Time Frame: 7 days
Number of lesions counted.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Study Director: Samantha Block, B.S., University of Miami
  • Principal Investigator: Brian Berman, M.D., Ph.D., University of Miami
  • Study Chair: Caroline Caperton, M.D., M.S.P.H., University of Miami
  • Study Chair: Whitney Valins, B.S., University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2010

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

September 1, 2010

First Submitted That Met QC Criteria

September 1, 2010

First Posted (ESTIMATE)

September 2, 2010

Study Record Updates

Last Update Posted (ACTUAL)

February 20, 2019

Last Update Submitted That Met QC Criteria

February 18, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20100520

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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