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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tissa Hata, MD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01929057
First received: August 21, 2013
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Acne
Procedure: Skin biopsy
Procedure: Blood draw

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Evaluation of the Role of Propionibacterium Acnes in the Inflammatory Lesions Associated With Acne Vulgaris

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Inflammatory markers [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • P. acnes antibody levels [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: August 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Acne patients
This group consists of patients who have at least moderate to severe acne on their back
Procedure: Skin biopsy
4-millimeter punch biopsies will be performed on all subjects (acne patients and healthy controls)
Procedure: Blood draw
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
Procedure: Skin biopsy
4-millimeter punch biopsies will be performed on all subjects (acne patients and healthy controls)
Procedure: Blood draw
Approximately half a tube of blood will be drawn from all participants in the study

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

community sample

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01929057

Locations
United States, California
UCSD Division of Dermatology
San Diego, California, United States, 92122
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Tissa Hata, MD UCSD
  More Information

No publications provided

Responsible Party: Tissa Hata, MD, MD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01929057     History of Changes
Other Study ID Numbers: 121230
Study First Received: August 21, 2013
Last Updated: June 19, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Facial Dermatoses
Sebaceous Gland Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 20, 2014