Clinical trial NCT01929057: Evaluation of the Role of Propionibacterium Acnes in the Inflammatory Lesions Associated With Acne Vulgaris
Official title: Evaluation of the Role of Propionibacterium Acnes in the Inflammatory Lesions Associated With Acne Vulgaris
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acne
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2013-08-27
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

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.


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

Primary outcomes:
measure: Level of IL-1β
timeFrame: post biopsy
Secondary outcomes:
measure: Level of Antibody to CAMP(Christie-Atkins-Munch-Petersen) Factor
timeFrame: post biopsy
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Division of Dermatology
state: California
Study officials:
affiliation: UCSD
name: Tissa Hata, MD
role: PRINCIPAL_INVESTIGATOR
References: