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

Sponsors and Collaborators: Harvard School of Public Health
Department of Dermatology, Leeds General Infirmary
Breast Cancer Research Foundation
Information provided by: Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT00132574

Purpose

The purpose of this study is to determine whether minimizing the intake of milk and dairy products will reduce the recurrence of acne among people who have been successfully treated for acne with isotretinoin.
Condition Intervention Phase
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

Official Title: Milk Minimization and Acne Recurrence Trial (MMART)

Further Study Details: 
Primary Outcomes: Number of recurrent acne lesions
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.

Eligibility

Ages Eligible for Study:  16 Years   -   25 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

• Patients aged between 16 and 25 years of age who have successfully completed treatment for acne with oral 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 grant informed consent for participation in the study. • Patients who agree to comply with the intervention and follow-up procedures in the study.

Exclusion Criteria:

• Patients who received isotretinoin for a condition other than acne (e.g Malassezia folliculitis).

• Patients who have been off isotretinoin for more than 60 days at the moment of enrolment in the study.

• Patients who used any topical or oral acne medications between the end of therapy with isotretinoin and 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:

  • Corticosteroids
  • Contraceptives containing medroxyprogesterone acetate, norgestrel or levonorgestrel
  • Dilantin or other antiepileptic.
  • Finasteride, spironolactone or flutamide
  • Testosterone or dietary body-building protein powders.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00132574

Jorge E Chavarro, MD, SM      617 432 4584    jchavarr@hsph.harvard.edu

United Kingdom
      Department of Dermatology, Leeds General Infirmary, Leeds,  LS1 3EX,  United Kingdom; Recruiting
June Williams, MA  +44 0113 392 2345 
Jennifer Lewis  +44 0113 392 3605 
Mark Goodfield, MD,  Principal Investigator
S Zaghloul, MD,  Sub-Investigator
June Williams, MA,  Sub-Investigator

Study chairs or principal investigators

Walter C Willett, MD, DrPH,  Principal Investigator,  Harvard School of Public Health   
Jorge E Chavarro, MD, SM,  Study Director,  Harvard School of Public Health   

More Information

Study ID Numbers:  BCRF-P11733; SRC200402
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

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