|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | August 19, 2005 | ||||||||||||
| Last Updated Date | September 20, 2006 | ||||||||||||
| Start Date ICMJE | August 2005 | ||||||||||||
| Primary Completion Date | |||||||||||||
| Current Primary Outcome Measures ICMJE |
Number of recurrent acne lesions | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT00132574 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
Time to re-initiation of treatment for acne | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Pilot Study of a Dietary Intervention to Prevent Acne Recurrence | ||||||||||||
| Official Title ICMJE | Milk Minimization and Acne Recurrence Trial (MMART) | ||||||||||||
| Brief Summary | 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. |
||||||||||||
| 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 Phase | Phase II | ||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study | ||||||||||||
| Condition ICMJE | Acne | ||||||||||||
| Intervention ICMJE | Behavioral: Minimization of milk and dairy products in the diet | ||||||||||||
| Study Arms / Comparison Groups | |||||||||||||
| Publications * | |||||||||||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||||||
| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Terminated | ||||||||||||
| Enrollment ICMJE | 30 | ||||||||||||
| Completion Date | September 2006 | ||||||||||||
| Primary Completion Date | |||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||
| Gender | Both | ||||||||||||
| Ages | 16 Years to 25 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United Kingdom | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00132574 | ||||||||||||
| Responsible Party | |||||||||||||
| Study ID Numbers ICMJE | BCRF-P11733, SRC200402 | ||||||||||||
| Study Sponsor ICMJE | Harvard School of Public Health | ||||||||||||
| Collaborators ICMJE |
|
||||||||||||
| Investigators ICMJE |
|
||||||||||||
| Information Provided By | Harvard School of Public Health | ||||||||||||
| Verification Date | September 2006 | ||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||