Acne Clinical Trial
Official title:
Plant-based Dietary Intervention for Treatment of Acne
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.
Status | Completed |
Enrollment | 43 |
Est. completion date | March 2010 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Male or female gender 2. Mild, moderate, or severe acne, as indicated by an Evaluator Global Severity Score (EGSS) score of 2, 3, or 4 3. Presence of at least 10 inflammatory or 20 non-inflammatory lesions on the face 4. Presence of acne for at least 3 months (by volunteer's history) 5. Age at least 18 years 6. Ability and willingness to participate in all components of the study 7. Willingness to be assigned randomly to a low-fat, vegan diet or a control group 8. Intention to remain in the Washington DC area for the 16-week study period. Exclusion Criteria: 1. Change in use or dosage of hormone-based contraceptives in the last 3 months or anticipated change during the study period. 2. Use of depot medoxyprogesterone contraception 3. Use of oral retinoids in the last 6 months 4. Use of high doses of vitamin A in the last 3 weeks (= 10,000 IU) 5. Use of oral antibiotics or topical antibacterial or retinoid agents in the last 1 month 6. Presence of more than two nodules or cysts on the face or more than two nodules or cysts on the back and chest. 7. Use of medications known to cause or exacerbate acne including lithium, oral or injected steroids, or medications containing iodides or bromides 8. History of alcohol abuse or dependency followed by any current use 9. Current or unresolved past drug or alcohol abuse 10. Facial hair that would interfere with making acne assessments 11. Pregnancy or breastfeeding (currently or in the past 3 months), or intent to become pregnant in the next 4 months 12. History of severe mental illness within the past 3 years 13. Unstable medical status 14. Current dietary pattern that is low-fat and vegan 15. Anticipated difficulty attending or participating in group sessions 16. Inordinate fear of blood draws 17. Diabetes treated with insulin or any other medications. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Washington Center for Clinical Research | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Physicians Committee for Responsible Medicine |
United States,
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of acne lesions | 16 weeks | No | |
Secondary | Diet acceptability and adherence | 16 weeks | No | |
Secondary | Acne severity and extent | 16 weeks | No | |
Secondary | Quality of life | 16 weeks | No |
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