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Milk Minimization and Acne Recurrence Trial (MMART)

Phase 2
16 Years
25 Years
Not Enrolling

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Trial Information

Milk Minimization and Acne Recurrence Trial (MMART)

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

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.

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

- Patients who grant informed consent for participation in the study.

- Patients who agree to comply with the intervention and follow-up procedures in the

Exclusion Criteria:

- Patients who received isotretinoin for a condition other than acne (e.g Malassezia

- 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

- Dilantin or other antiepileptic;

- Finasteride, spironolactone or flutamide;

- Testosterone or dietary body-building protein powders.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Outcome Measure:

Number of recurrent acne lesions

Principal Investigator

Walter C Willett, MD, DrPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Harvard School of Public Health


United States: Institutional Review Board

Study ID:




Start Date:

August 2005

Completion Date:

September 2006

Related Keywords:

  • Acne
  • acne, dairy
  • Acne Vulgaris
  • Recurrence