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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University of Miami.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT01193764
First received: September 1, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Acne
Dietary Supplement: 100% cocoa powder
Dietary Supplement: gelatin (Gelita)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Double Blind Placebo Controlled Study Assessing the Effect of Chocolate Consumption in Subjects With A History of Acne Vulgaris

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • development of acneiform lesions [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Evaluations will be performed using clinical assessments 4 days and 7 days after baseline evaluations (+/- 1 days).


Estimated Enrollment: 24
Study Start Date: September 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • hydrolyzed gelatin (Gelita)
  • blue and white gelatin capsules (Capsuline)

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01193764

Contacts
Contact: Samantha Block, B.S. 305-243-5519 sblock@med.miami.edu
Contact: Caroline Caperton, M.D. 305-243-5519 dermatology.research@med.miami.edu

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Sam Block, B.S.    305-243-5519    sblock@med.miami.edu   
Contact: Caroline Caperton, M.D., M.S.P.H.    305-243-5519    dermatology.research@med.miami.edu   
Principal Investigator: Brian Berman, M.D., Ph.D.         
Sub-Investigator: Samantha Block, B.S.         
Sub-Investigator: Caroline Caperton, M.D., M.S.P.H.         
Sub-Investigator: Whitney Valins, B.S.         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Brian Berman, Ph.D., M.D., University of Miami, Department of Dermatology and Cutaneous Surgery
ClinicalTrials.gov Identifier: NCT01193764     History of Changes
Other Study ID Numbers: 20100520 - Intramural - Berman
Study First Received: September 1, 2010
Last Updated: September 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
acne
cocoa
chocolate
gelatin
pustule
comedones
papules
pustules

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Facial Dermatoses
Sebaceous Gland Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 22, 2014