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Pilot Study of a Dietary Intervention to Prevent Acne Recurrence

Primary Purpose

Acne

Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Minimization of milk and dairy products in the diet
Sponsored by
Harvard School of Public Health (HSPH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acne focused on measuring acne, dairy

Eligibility Criteria

16 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Dermatology, Leeds General Infirmary

Outcomes

Primary Outcome Measures

Number of recurrent acne lesions

Secondary Outcome Measures

Time to re-initiation of treatment for acne

Full Information

First Posted
August 19, 2005
Last Updated
September 20, 2006
Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Department of Dermatology, Leeds General Infirmary, Breast Cancer Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00132574
Brief Title
Pilot Study of a Dietary Intervention to Prevent Acne Recurrence
Official Title
Milk Minimization and Acne Recurrence Trial (MMART)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Terminated
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Department of Dermatology, Leeds General Infirmary, Breast Cancer Research Foundation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
Keywords
acne, dairy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Minimization of milk and dairy products in the diet
Primary Outcome Measure Information:
Title
Number of recurrent acne lesions
Secondary Outcome Measure Information:
Title
Time to re-initiation of treatment for acne

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter C Willett, MD, DrPH
Organizational Affiliation
Harvard School of Public Health (HSPH)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jorge E Chavarro, MD, SM
Organizational Affiliation
Harvard School of Public Health (HSPH)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
F. William Danby, MD, FRCPC
Official's Role
Study Director
Facility Information:
Facility Name
Department of Dermatology, Leeds General Infirmary
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom

12. IPD Sharing Statement

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Pilot Study of a Dietary Intervention to Prevent Acne Recurrence

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