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

University of California San Diego

Status: Completed

Conditions: Acne

Treatments: Procedure: Skin biopsy; Procedure: Blood draw

Study type: Observational

Funder types: Other

Identifiers

NCT01929057

121230

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

34 participants in 2 patient groups

Acne patients

Description:

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

Treatment:

Procedure: Skin biopsy

Procedure: Blood draw

Healthy Controls

Description:

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

Treatment:

Procedure: Skin biopsy

Procedure: Blood draw