Status:
TERMINATED
Study Assessing the Effect of Chocolate Consumption in Subjects With A History of Acne Vulgaris
Lead Sponsor:
University of Miami
Conditions:
Acne
Eligibility:
MALE
18-35 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01193764
Start Date
September 1 2010
End Date
July 1 2012
Last Update
February 20 2019
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136