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.

Study Overview

• Status: Terminated
• Conditions: Acne
• Intervention / Treatment: Behavioral: Minimization of milk and dairy products in the diet

Detailed Description

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.

• Study Type: Interventional
• Enrollment: 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS1 3EX
    • Department of Dermatology, Leeds General Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 23 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Number of recurrent acne lesions

Secondary Outcome Measures

Outcome Measure
Time to re-initiation of treatment for acne

Collaborators and Investigators

• Sponsor: Harvard School of Public Health (HSPH)
• Collaborators: Breast Cancer Research Foundation; Department of Dermatology, Leeds General Infirmary
• Investigators: Principal Investigator: Walter C Willett, MD, DrPH, Harvard School of Public Health (HSPH); Study Director: Jorge E Chavarro, MD, SM, Harvard School of Public Health (HSPH); Study Director: F. William Danby, MD, FRCPC

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Study Completion: September 1, 2006

Study Registration Dates

• First Submitted: August 19, 2005
• First Submitted That Met QC Criteria: August 19, 2005
• First Posted (Estimate): August 22, 2005

Study Record Updates

• Last Update Posted (Estimate): September 21, 2006
• Last Update Submitted That Met QC Criteria: September 20, 2006
• Last Verified: September 1, 2006

More Information

Terms related to this study

• Keywords: acne, dairy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: BCRF-P11733; SRC200402