Suspended

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

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What is being tested

100% cocoa powder

+ gelatin (Gelita)

Dietary Supplement
Who is being recruted

Acne Vulgaris+2

+ Sebaceous Gland Diseases

+ Skin Diseases

From 18 to 35 Years
+27 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Placebo-Controlled
Interventional
Study Start: September 2010
See protocol details

Summary

Principal SponsorUniversity of Miami
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2010

Actual date on which the first participant was enrolled.

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.

Official TitleDouble Blind Placebo Controlled Study Assessing the Effect of Chocolate Consumption in Subjects With A History of Acne Vulgaris
NCT01193764
Principal SponsorUniversity of Miami
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

14 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 35 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Acne VulgarisSebaceous Gland DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAcneiform Eruptions

Criteria

10 inclusion criteria required to participate
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
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17 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
unsweetened 100% cocoa (Ghirardelli)

Group II

Placebo
hydrolyzed gelatin powder (Gelita)

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Miami

Miami, United StatesOpen University of Miami in Google Maps
SuspendedOne Study Center