ClinicalTrials.gov processed this data on March 28, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT00132574BCRF-P11733SRC200402NCT00132574Pilot Study of a Dietary Intervention to Prevent Acne RecurrenceMilk Minimization and Acne Recurrence Trial (MMART)Harvard School of Public Health (HSPH)OtherDepartment of Dermatology, Leeds General InfirmaryOtherBreast Cancer Research FoundationOther
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.
TerminatedAugust 2005September 2006Phase 2InterventionalNoRandomizedParallel AssignmentPreventionSingleNumber of recurrent acne lesionsTime to re-initiation of treatment for acne30AcneBehavioralMinimization of milk and dairy products in the diet
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.
All16 Years25 YearsNoWalter C Willett, MD, DrPHPrincipal InvestigatorHarvard School of Public Health (HSPH)Jorge E Chavarro, MD, SMStudy DirectorHarvard School of Public Health (HSPH)F. William Danby, MD, FRCPCStudy DirectorDepartment of Dermatology, Leeds General InfirmaryLeedsLS1 3EXUnited KingdomUnited KingdomSeptember 2006August 19, 2005August 19, 2005August 22, 2005September 20, 2006September 20, 2006September 21, 2006acne, dairyRecurrence