AcneNCT01193764
Study Assessing the Effect of Chocolate Consumption in Subjects With A History of Acne Vulgaris
A study testing 100% cocoa powder and gelatin (Gelita) in people with Acne, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- 100% cocoa powder and gelatin (Gelita)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind Placebo Controlled Study Assessing the Effect of Chocolate Consumption in Subjects With A History of Acne Vulgaris
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.
- Conditions
- Acne
- Being tested
- 100% cocoa powder, gelatin (Gelita)
- Keywords
- acne, cocoa, chocolate, gelatin, pustule, comedones, papules, pustules
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100% cocoa powderDietary supplement
Also called 100% cocoa powder (Ghirardelli ©), blue and white gelatin capsules (Capsuline)
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).
gelatin (Gelita)Dietary supplement
Also called hydrolyzed gelatin (Gelita), blue and white gelatin capsules (Capsuline)
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).
| Study group | Role | What they receive |
|---|---|---|
| cocoa | Experimental | unsweetened 100% cocoa (Ghirardelli) Receives: Dietary Supplement: 100% cocoa powder |
| placebo | Placebo comparator | hydrolyzed gelatin powder (Gelita) Receives: Dietary Supplement: gelatin (Gelita) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of acneiform lesions
Number of lesions counted.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert S. Kirsner, University of Miami
- Investigators
- Samantha Block, B.S., Study director, University of MiamiBrian Berman, M.D., Ph.D., Principal investigator, University of MiamiCaroline Caperton, M.D., M.S.P.H., Study chair, University of MiamiWhitney Valins, B.S., Study chair, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193764
- Sponsor's protocol ID
- 20100520
- Status last verified
- Feb 2019
- First submitted
- 1 Sep 2010
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Placebo Controlled Study Assessing the Effect of Chocolate Consumption in Subjects With A History of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT01193764
- Acronym / sponsor ID
- 20100520
- Conditions
- Acne
- Keywords
- acne, cocoa, chocolate, gelatin, pustule, comedones, papules, pustules
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Sep 2010 (actual)
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 2 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cocoa | Experimental | Dietary Supplement: 100% cocoa powderunsweetened 100% cocoa (Ghirardelli) |
| placebo | Placebo comparator | Dietary Supplement: gelatin (Gelita)hydrolyzed gelatin powder (Gelita) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 100% cocoa powderAlso: 100% cocoa powder (Ghirardelli ©), blue and white gelatin capsules (Capsuline)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). | Dietary supplement | cocoa |
| gelatin (Gelita)Also: hydrolyzed gelatin (Gelita), blue and white gelatin capsules (Capsuline)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). | Dietary supplement | placebo |
Primary outcome
Number of acneiform lesions
Time frame: 7 days
Number of lesions counted.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samantha Block, B.S. study director
University of Miami
Brian Berman, M.D., Ph.D. principal investigator
University of Miami
Caroline Caperton, M.D., M.S.P.H. study chair
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 100% cocoa powder and gelatin (Gelita) in people with Acne, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of acneiform lesions (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.