Status:
COMPLETED
Plant-based Dietary Intervention for Treatment of Acne
Lead Sponsor:
Physicians Committee for Responsible Medicine
Conditions:
Acne
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00900939
Start Date
July 1 2009
End Date
March 1 2010
Last Update
August 7 2012
Active Locations (1)
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1
Washington Center for Clinical Research
Washington D.C., District of Columbia, United States, 20016