AcnePhase 2NCT00132574
Pilot Study of a Dietary Intervention to Prevent Acne Recurrence
A Phase 2 study testing Minimization of milk and dairy products in the diet in people with Acne, run by Harvard School of Public Health (HSPH) at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Acne
- What is being tested?
- Minimization of milk and dairy products in the diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2005to Sep 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- Contraceptives containing medroxyprogesterone acetate, norgestrel or levonorgestrel;
- Dilantin or other antiepileptic;
- Finasteride, spironolactone or flutamide;
- Testosterone or dietary body-building protein powders.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Dermatology, Leeds General Infirmary
Leeds, LS1 3EX
About this study
Official title: Milk Minimization and Acne Recurrence Trial (MMART)
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.
Read the 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.
- Conditions
- Acne
- Being tested
- Minimization of milk and dairy products in the diet
- Keywords
- acne, dairy
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimization of milk and dairy products in the dietBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of recurrent acne lesions
Secondary outcomes (1)
Time to re-initiation of treatment for acne
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startAug 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Dermatology, Leeds General Infirmary, Breast Cancer Research Foundation
- Investigators
- Walter C Willett, MD, DrPH, Principal investigator, Harvard School of Public Health (HSPH)Jorge E Chavarro, MD, SM, Study director, Harvard School of Public Health (HSPH)F. William Danby, MD, FRCPC, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132574
- Sponsor's protocol ID
- BCRF-P11733
- Other IDs
- SRC200402
- Status last verified
- Sep 2006
- First submitted
- 19 Aug 2005
- Last updated
- 21 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milk Minimization and Acne Recurrence Trial (MMART)
- ClinicalTrials.gov ID
- NCT00132574
- Acronym / sponsor ID
- BCRF-P11733
- Conditions
- Acne
- Keywords
- acne, dairy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Department of Dermatology, Leeds General Infirmary, Breast Cancer Research Foundation
- Study start
- Aug 2005
- Study completion
- Sep 2006
- First posted
- 22 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimization of milk and dairy products in the diet | Behavioural | – |
Primary outcome
Number of recurrent acne lesions
1 secondary outcome
Time to re-initiation of treatment for acne
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter C Willett, MD, DrPH principal investigator
Harvard School of Public Health (HSPH)
Jorge E Chavarro, MD, SM study director
Harvard School of Public Health (HSPH)
F. William Danby, MD, FRCPC study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Minimization of milk and dairy products in the diet in people with Acne, run by Harvard School of Public Health (HSPH) at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of recurrent acne lesions. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2006.