Evaluation of the Role of Propionibacterium Acnes in the Inflammatory Lesions Associated With Acne Vulgaris



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 60
Updated:5/5/2014
Start Date:August 2013
End Date:October 2013
Contact:Aimee Two, MD
Email:ucsddermstudies@gmail.com
Phone:858-657-8390

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The purpose of this study is to determine the response of acne patients and healthy control
patients to the P. acnes bacteria. Half a tube of blood will be drawn from all participants
to determine whether or not they have antibodies to the P. acnes bacterium. Anywhere from 1
to 4 skin biopsies of acne pimples or normal control skin will be taken from all subjects
for further analysis in the lab to determine whether the inflammation in these pimples can
be reduced using anti-P.acnes antibodies.


Inclusion Criteria:

- Fits into one of the following diagnostic groups:

1. Healthy subject with no active skin disease or history of skin disease

2. Diagnosis of moderate-to-severe truncal acne diagnosed clinically and confirmed
using the modified Leeds criteria with no reported use of topical acne
treatments within the past 2 weeks prior to enrollment in the study, and no
reported use of oral acne treatments during the past 4 weeks prior to enrollment
in the study

3. Diagnosis of moderate-to-severe truncal acne diagnosed clinically and confirmed
using the modified Leeds criteria who has used any topical acne treatments in
the 2 weeks prior to enrolling in the study, or who has used any oral acne
treatments during the 4 weeks prior to enrolling in the study 2. Age 18-60
years 3. Male or female of any race and ethnicity 4. Subject agrees to comply
with study requirements

Exclusion Criteria:

1. Subjects with severe medical condition(s) that in the view of the investigator
prohibits participation in the study

2. Subject has Netherton's syndrome or other genodermatoses that result in a defective
epidermal barrier

3. Pregnant or nursing females

4. Immunocompromised subjects (e.g., lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome), or
with a history of active or malignant disease (excluding non-melanoma skin cancer) as
determined by the participant's medical history.

5. Subjects with a history of psychiatric disease or history of alcohol or drug abuse
that would interfere with the ability to comply with the study protocol

6. Subjects with significant concurrent medical condition(s) at screening that in the
view of the investigator prohibits participation in the study (e.g., severe
concurrent allergic disease, condition associated with malignancy, and condition
associated with immunosuppression)

7. Active viral or fungal skin infections at the target areas

8. Are currently receiving lithium now or within the last 4 weeks.

9. Ongoing participation in an investigational drug trial

10. Use of any systemic immunosuppressive therapy less than four weeks prior to
screening.

11. Subjects with diabetes

12. Injured, broken skin that, per the investigator, may lead to poor wound healing

13. Subjects with allergies to anesthetic medications
We found this trial at
1
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San Diego, California 92122
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San Diego, CA
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