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Pilot Study of a Dietary Intervention to Prevent Acne Recurrence
This study has been terminated.
Study NCT00132574   Information provided by Harvard School of Public Health
First Received: August 19, 2005   Last Updated: September 20, 2006   History of Changes

August 19, 2005
September 20, 2006
August 2005
 
Number of recurrent acne lesions
Same as current
Complete list of historical versions of study NCT00132574 on ClinicalTrials.gov Archive Site
Time to re-initiation of treatment for acne
Same as current
 
Pilot Study of a Dietary Intervention to Prevent Acne Recurrence
Milk Minimization and Acne Recurrence Trial (MMART)

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.

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.

Phase II
Interventional
Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Acne
Behavioral: Minimization of milk and dairy products in the diet
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
30
September 2006
 

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 at the Leeds 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 into 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.
Both
16 Years to 25 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00132574
 
BCRF-P11733, SRC200402
Harvard School of Public Health
  • The Leeds Teaching Hospitals NHS Trust
  • Breast Cancer Research Foundation
Principal Investigator: Walter C Willett, MD, DrPH Harvard School of Public Health
Study Director: Jorge E Chavarro, MD, SM Harvard School of Public Health
Study Director: F. William Danby, MD, FRCPC Unaffiliated
Harvard School of Public Health
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP