Back to resultsStudy Assessing the Effect of Chocolate Consumption in Subjects With A History of Acne Vulgaris
Primary Purpose
Acne
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
100% cocoa powder
gelatin (Gelita)
Sponsored by
About this trial
This is an interventional diagnostic trial for Acne focused on measuring acne, cocoa, chocolate, gelatin, pustule, comedones, papules, pustules
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
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
cocoa
placebo
Arm Description
unsweetened 100% cocoa (Ghirardelli)
hydrolyzed gelatin powder (Gelita)
Outcomes
Primary Outcome Measures
Number of acneiform lesions
Number of lesions counted.
Secondary Outcome Measures
Full Information
NCT ID
NCT01193764
First Posted
September 1, 2010
Last Updated
February 18, 2019
Sponsor
University of Miami
1. Study Identification
Unique Protocol Identification Number
NCT01193764
Brief Title
Study Assessing the Effect of Chocolate Consumption in Subjects With A History of Acne Vulgaris
Official Title
Double Blind Placebo Controlled Study Assessing the Effect of Chocolate Consumption in Subjects With A History of Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Study Start Date
September 2010 (Actual)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
Keywords
acne, cocoa, chocolate, gelatin, pustule, comedones, papules, pustules
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cocoa
Arm Type
Experimental
Arm Description
unsweetened 100% cocoa (Ghirardelli)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
hydrolyzed gelatin powder (Gelita)
Intervention Type
Dietary Supplement
Intervention Name(s)
100% cocoa powder
Other Intervention Name(s)
100% cocoa powder (Ghirardelli ©), blue and white gelatin capsules (Capsuline)
Intervention Description
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
Intervention Name(s)
gelatin (Gelita)
Other Intervention Name(s)
hydrolyzed gelatin (Gelita), blue and white gelatin capsules (Capsuline)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of acneiform lesions
Description
Number of lesions counted.
Time Frame
7 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samantha Block, B.S.
Organizational Affiliation
University of Miami
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Brian Berman, M.D., Ph.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Caroline Caperton, M.D., M.S.P.H.
Organizational Affiliation
University of Miami
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Whitney Valins, B.S.
Organizational Affiliation
University of Miami
Official's Role
Study Chair
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
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Study Assessing the Effect of Chocolate Consumption in Subjects With A History of Acne Vulgaris
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