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

NCT ID: NCT01929057

Last Updated: 2019-10-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 34 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-06-30

Brief Summary

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.

Conditions

Acne

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Acne patients

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

Skin biopsy

Intervention Type: PROCEDURE

4-millimeter punch biopsies will be performed on all subjects (acne patients and healthy controls)

Blood draw

Intervention Type: PROCEDURE

Approximately half a tube of blood will be drawn from all participants in the study

Healthy Controls

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

Skin biopsy

Intervention Type: PROCEDURE

4-millimeter punch biopsies will be performed on all subjects (acne patients and healthy controls)

Blood draw

Intervention Type: PROCEDURE

Approximately half a tube of blood will be drawn from all participants in the study

Interventions

Skin biopsy

4-millimeter punch biopsies will be performed on all subjects (acne patients and healthy controls)

Intervention Type: PROCEDURE

Blood draw

Approximately half a tube of blood will be drawn from all participants in the study

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Tissa Hata, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tissa Hata, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

UCSD Division of Dermatology

San Diego, California, United States

Countries

United States

Other Identifiers

121230

Identifier Type: -

Identifier Source: org_study_id