Pilot Study of a Dietary Intervention to Prevent Acne Recurrence - Article Pimples; Zits
Clinical Trial: Pilot Study of a Dietary Intervention to Prevent Acne Recurrence
This study is currently recruiting patients.
Verified by Harvard School of Public Health August 2005
|Acne || Behavior: Minimization of milk and dairy products in the diet ||Phase II |
MedlinePlus related topics: Acne
Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Secondary Outcomes: Time to re-initiation of treatment for acne
Expected Total Enrollment: 30
Study start: August 2005; Expected completion: February 2007
Last follow-up: September 2006; Data entry closure: November 2006
Acne is one of the most common dermatologic diseases affecting 40 to 50 million people in the United States, most of who are adolescents and young adults. In addition to the well-recognized physical sequelae of this condition, several studies have linked severe acne to considerable social impairments and serious psychological conditions including suicidal ideation and major depression. Furthermore, severe acne has been recognized in some studies as a risk factor for breast cancer, suggesting that these conditions may have common causes. Little is known about the role of diet in the pathogenesis of acne. Recent analyses of the Nurses’ Health Study II and the Growing-Up Today Study suggest that high intake of milk increases the risk of developing acne during adolescence. Despite the consistency of findings between these two studies, they cannot be regarded as conclusive and further research is needed in this area. Establishing the nature of the association between milk intake and acne can have broad clinical and public health implications. It could enhance the currently existing therapeutic options for the treatment of acne. More importantly, public health recommendations regarding milk and dairy intake could be designed in order to prevent its effects on the sebaceous glands and probably other hormone sensitive glands like the breast.
To test the hypothesis that milk intake increases the risk of developing acne, we will compare the effect of minimizing milk and dairy intake against not making changes in the diet of subjects who usually consume at least 2 servings/day of milk and dairy products on the recurrence of acne lesions among patients previously treated with isotretinoin.
• Patients who regularly consume at least 2 servings (480ml) of milk per day. • Patients who can attend scheduled study follow-up visits to the General Infirmary.
• Patients who have been off isotretinoin for more than 60 days at the moment of enrolment in the study.
• Patients who have been previously diagnosed with an endocrinologic disorder likely to cause acne such as polycystic ovary syndrome, congenital adrenal hyperplasia, adrenal or ovarian tumors or any other hyperandrogenemic states.
• Patients who are using any of the following medications which are likely to cause or abate acne:
Location and Contact Information
Department of Dermatology, Leeds General Infirmary, Leeds, LS1 3EX, United Kingdom; Recruiting
Jennifer Lewis +44 0113 392 3605
Mark Goodfield, MD, Principal Investigator
S Zaghloul, MD, Sub-Investigator
June Williams, MA, Sub-Investigator
Walter C Willett, MD, DrPH, Principal Investigator, Harvard School of Public Health
Jorge E Chavarro, MD, SM, Study Director, Harvard School of Public Health
Last Updated: August 19, 2005
Record first received: August 19, 2005
ClinicalTrials.gov Identifier: NCT00132574
Health Authority: United States: Institutional Review Board; United Kingdom: Research Ethics Committee
ClinicalTrials.gov processed this record on 2005-08-23