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

Acne research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Acne

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:Skin biopsy4-millimeter punch biopsies will be performed on all subjects (acne patients and healthy controls)

Procedure:Blood drawApproximately half a tube of blood will be drawn from all participants in the study

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Acne patientsThis group consists of patients who have at least moderate to severe acne on their back

Healthy ControlsThis group contains participants who do not have any active acne lesions on their back

Study Status

Completed

Start Date: August 2013

Completed Date: June 2014

Phase: N/A

Type: Observational

Design:

Primary Outcome: Inflammatory markers

Secondary Outcome: P. acnes antibody levels

Study sponsors, principal investigator, and references

Principal Investigator: Tissa Hata, MD

Lead Sponsor: University of California, San Diego

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01929057

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