Pilot Study of a Dietary Intervention to Prevent Acne Recurrence

NCT00132574 | Terminated Phase 2

• 2 other identifiers: BCRF-P11733SRC200402
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne

Keywords

acne, dairy

Outcome Measures

Primary Outcomes (1)

• Number of recurrent acne lesions

Secondary Outcomes (1)

• Time to re-initiation of treatment for acne

Interventions

Minimization of milk and dairy products in the diet BEHAVIORAL

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Department of Dermatology, Leeds General Infirmary: collaborator
• Breast Cancer Research Foundation: collaborator

Study Sites (1)

Department of Dermatology, Leeds General Infirmary

Leeds, LS1 3EX, United Kingdom

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Dairy Products

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Walter C Willett, MD, DrPH

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

• Jorge E Chavarro, MD, SM

  Harvard School of Public Health (HSPH)

  STUDY DIRECTOR

• F. William Danby, MD, FRCPC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 19, 2005
• First Posted: August 22, 2005
• Study Start: August 1, 2005
• Study Completion: September 1, 2006
• Last Updated: September 21, 2006

Record last verified: 2006-09

Locations

GB (1)