AcneNCT00900939
Plant-based Dietary Intervention for Treatment of Acne
A study testing Low-fat, vegan diet in people with Acne, run by Physicians Committee for Responsible Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine if a low-fat, vegan diet affects the number of acne lesions, acne severity, and acne extent. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- Low-fat, vegan diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Mar 2010
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female gender
- Mild, moderate, or severe acne, as indicated by an Evaluator Global Severity Score (EGSS) score of 2, 3, or 4
- Presence of at least 10 inflammatory or 20 non-inflammatory lesions on the face
- Presence of acne for at least 3 months (by volunteer's history)
- Age at least 18 years
- Ability and willingness to participate in all components of the study
- Willingness to be assigned randomly to a low-fat, vegan diet or a control group
- Intention to remain in the Washington DC area for the 16-week study period.
Who cannot join
- Change in use or dosage of hormone-based contraceptives in the last 3 months or anticipated change during the study period.
- Use of depot medoxyprogesterone contraception
- Use of oral retinoids in the last 6 months
- Use of high doses of vitamin A in the last 3 weeks (≥ 10,000 IU)
- Use of oral antibiotics or topical antibacterial or retinoid agents in the last 1 month
- Presence of more than two nodules or cysts on the face or more than two nodules or cysts on the back and chest.
Show all 17Show fewer
- Use of medications known to cause or exacerbate acne including lithium, oral or injected steroids, or medications containing iodides or bromides
- History of alcohol abuse or dependency followed by any current use
- Current or unresolved past drug or alcohol abuse
- Facial hair that would interfere with making acne assessments
- Pregnancy or breastfeeding (currently or in the past 3 months), or intent to become pregnant in the next 4 months
- History of severe mental illness within the past 3 years
- Unstable medical status
- Current dietary pattern that is low-fat and vegan
- Anticipated difficulty attending or participating in group sessions
- Inordinate fear of blood draws
- Diabetes treated with insulin or any other medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Center for Clinical Research
Washington D.C., District of Columbia, 20016
About this study
The purpose of this study is to determine if a low-fat, vegan diet affects the number of acne lesions, acne severity, and acne extent.
Read the detailed description
Acne is the most common skin disorder in the United States. Although many cases are transient, the condition is often chronic, causing self-consciousness and social stigmatization over the short term and physical scars and damaged self-esteem over the long term. Patients and clinicians have frequently attributed acnegenesis to diet; studies of varying quality have been published on the topic since the 1830s. Recently, well-designed, controlled, prospective studies suggest an acnegenic effect of specific dietary factors, including high-glycemic-index foods and dairy products. Limited evidence also suggests an acnegenic effect of foods containing saturated fats. More well-designed, randomized, controlled trials are needed to further establish dietary effects on acne. Based on epidemiologic observations and results of prior clinical trials, we are conducting a pilot study to determine if a low-fat, low-glycemic-index vegan diet affects the number of acne lesions and acne severity.
- Conditions
- Acne
- Being tested
- Low-fat, vegan diet, Control
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-fat, vegan dietBehavioural
Participants in the intervention group will be asked to follow a low-fat, vegan diet for the full 16 weeks of the study. They will also be guided to favor foods with a low glycemic index. The diet consists of whole grains, vegetables, legumes, and fruits, with no restriction on energy intake. Animal products, added oils, and added sugars will be excluded.
ControlBehavioural
Participants assigned to the control group will be instructed to follow their usual diets for the full 16 weeks of the study.
| Study group | Role | What they receive |
|---|---|---|
| Low-fat, vegan diet | Experimental | Not described Receives: Behavioral: Low-fat, vegan diet |
| Control | Placebo comparator | Not described Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of acne lesions
Measured: 16 weeks
Secondary outcomes (3)
Diet acceptability and adherence
Measured: 16 weeks
Acne severity and extent
Measured: 16 weeks
Quality of life
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startJul 2009
- Primary completionNov 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcneStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Physicians Committee for Responsible Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900939
- Sponsor's protocol ID
- Acne001
- Status last verified
- Aug 2012
- First submitted
- 11 May 2009
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Spencer EH, Ferdowsian HR, Barnard ND. Diet and acne: a review of the evidence. Int J Dermatol. 2009 Apr;48(4):339-47. doi: 10.1111/j.1365-4632.2009.04002.x. No abstract available.
PubMed 19335417
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plant-based Dietary Intervention for Treatment of Acne
- ClinicalTrials.gov ID
- NCT00900939
- Acronym / sponsor ID
- Acne001
- Conditions
- Acne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Physicians Committee for Responsible MedicineUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 13 May 2009 (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 purpose of this study is to determine if a low-fat, vegan diet affects the number of acne lesions, acne severity, and acne extent.
Detailed description
Acne is the most common skin disorder in the United States. Although many cases are transient, the condition is often chronic, causing self-consciousness and social stigmatization over the short term and physical scars and damaged self-esteem over the long term. Patients and clinicians have frequently attributed acnegenesis to diet; studies of varying quality have been published on the topic since the 1830s. Recently, well-designed, controlled, prospective studies suggest an acnegenic effect of specific dietary factors, including high-glycemic-index foods and dairy products. Limited evidence also suggests an acnegenic effect of foods containing saturated fats. More well-designed, randomized, controlled trials are needed to further establish dietary effects on acne. Based on epidemiologic observations and results of prior clinical trials, we are conducting a pilot study to determine if a low-fat, low-glycemic-index vegan diet affects the number of acne lesions and acne severity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-fat, vegan diet | Experimental | Behavioral: Low-fat, vegan diet |
| Control | Placebo comparator | Behavioral: Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female gender
- Mild, moderate, or severe acne, as indicated by an Evaluator Global Severity Score (EGSS) score of 2, 3, or 4
- Presence of at least 10 inflammatory or 20 non-inflammatory lesions on the face
- Presence of acne for at least 3 months (by volunteer's history)
- Age at least 18 years
Key exclusion criteria (17 listed)
- Change in use or dosage of hormone-based contraceptives in the last 3 months or anticipated change during the study period.
- Use of depot medoxyprogesterone contraception
- Use of oral retinoids in the last 6 months
- Use of high doses of vitamin A in the last 3 weeks (≥ 10,000 IU)
- Use of oral antibiotics or topical antibacterial or retinoid agents in the last 1 month
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 |
|---|---|---|
| Low-fat, vegan dietParticipants in the intervention group will be asked to follow a low-fat, vegan diet for the full 16 weeks of the study. They will also be guided to favor foods with a low glycemic index. The diet consists of whole grains, vegetables, legumes, and fruits, with no restriction on energy intake. Animal products, added oils, and added sugars will be excluded. | Behavioural | Low-fat, vegan diet |
| ControlParticipants assigned to the control group will be instructed to follow their usual diets for the full 16 weeks of the study. | Behavioural | Control |
Primary outcome
Number of acne lesions
Time frame: 16 weeks
3 secondary outcomes
Diet acceptability and adherence
Time frame: 16 weeks
Acne severity and extent
Time frame: 16 weeks
Quality of life
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Background: PubMed 19335417Spencer EH, Ferdowsian HR, Barnard ND. Diet and acne: a review of the evidence. Int J Dermatol. 2009 Apr;48(4):339-47. doi: 10.1111/j.1365-4632.2009.04002.x. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-fat, vegan diet in people with Acne, run by Physicians Committee for Responsible Medicine 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 8 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: finished, as of the sponsor's last update on 7 Aug 2012. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 acne lesions (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00900939, which also lists 1 linked publication.
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 7 Aug 2012.