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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01193764
• Date of registration: 01/09/2010
• Primary sponsor: University of Miami
• Public title: Study Assessing the Effect of Chocolate Consumption in Subjects With A History of Acne Vulgaris
• Scientific title: Double Blind Placebo Controlled Study Assessing the Effect of Chocolate Consumption in Subjects With A History of Acne Vulgaris
• Date of first enrolment: September 2010
• Target sample size: 24
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01193764
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Countries of recruitment

United States

Contacts

• Name: Sam Block, B.S.

• Name: Samantha Block, B.S.

• Name: Brian Berman, M.D., Ph.D.
• Affiliation: University of Miami

• Name: Caroline Caperton, M.D., M.S.P.H.
• Affiliation: University of Miami

• Name: Samantha Block, B.S.
• Affiliation: University of Miami

• Name: Whitney Valins, B.S.
• Affiliation: University of Miami

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 35 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Acne

Intervention(s)

Dietary Supplement: 100% cocoa powder

Dietary Supplement: gelatin (Gelita)

Primary Outcome(s)

development of acneiform lesions [Time Frame: 7 days]

Secondary ID(s)

20100520 - Intramural - Berman

Source(s) of Monetary Support

Please refer to primary and secondary sponsors