Plant-based Dietary Intervention for Treatment of Acne

Acne Clinical Trial

Official title:

Plant-based Dietary Intervention for Treatment of Acne

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00900939
• Other study ID #: Acne001
• Status: Completed
• Phase: N/A
• First received: May 11, 2009
• Last updated: August 6, 2012
• Start date: July 2009
• Est. completion date: March 2010

Study information

• Verified date: August 2012
• Source: Physicians Committee for Responsible Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne

Intervention

Behavioral:
• Low-fat, vegan diet
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.
• Control
Participants assigned to the control group will be instructed to follow their usual diets for the full 16 weeks of the study.

Locations

Country	Name	City	State
United States	Washington Center for Clinical Research	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Physicians Committee for Responsible Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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