Status:
TERMINATED
Pilot Study of a Dietary Intervention to Prevent Acne Recurrence
Lead Sponsor:
Harvard School of Public Health (HSPH)
Collaborating Sponsors:
Department of Dermatology, Leeds General Infirmary
Breast Cancer Research Foundation
Conditions:
Acne
Eligibility:
All Genders
16-25 years
Phase:
PHASE2
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 isot...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00132574
Start Date
August 1 2005
End Date
September 1 2006
Last Update
September 21 2006
Active Locations (1)
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1
Department of Dermatology, Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX