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

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ClinicalTrials.gov Identifier: NCT01929057
Recruitment Status : Completed
First Posted : August 27, 2013
Results First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Tissa Hata, MD, University of California, San Diego

Tracking Information
First Submitted Date August 21, 2013
First Posted Date August 27, 2013
Results First Submitted Date June 4, 2019
Results First Posted Date October 3, 2019
Last Update Posted Date October 3, 2019
Study Start Date August 2013
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 2, 2019)
Level of IL-1β [ Time Frame: post biopsy ]
The amount of IL-1β, an inflammatory marker, is measured in skin biopsies obtained from healthy patients and compared with levels in biopsies of acne lesions.
Original Primary Outcome Measures
 (submitted: August 21, 2013)
Inflammatory markers [ Time Frame: Baseline ]
Change History Complete list of historical versions of study NCT01929057 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 2, 2019)
Level of Antibody to CAMP(Christie-Atkins-Munch-Petersen) Factor [ Time Frame: post biopsy ]
Antibody titers were determined by using recombinant CAMP factor or green fluorescent protein (GFP) as a capture antigen for coating onto a enzyme-linked immunosorbent assay (ELISA) plate. The endpoint was defined as the dilution of serum on CAMP factor-coated wells producing the same Optical Density(570-450) as a 1/100 dilution of serum on GFP-coated wells. Sera negative at the lowest dilution tested were assigned endpoint titers of 100. The data were presented as geometric mean endpoint ELISA titers.
Original Secondary Outcome Measures
 (submitted: August 21, 2013)
P. acnes antibody levels [ Time Frame: Baseline ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population community sample
Condition Acne
Intervention
  • 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
Study Groups/Cohorts
  • Acne patients
    This group consists of patients who have at least moderate to severe acne on their back
    Interventions:
    • Procedure: Skin biopsy
    • Procedure: Blood draw
  • Healthy Controls
    This group contains participants who do not have any active acne lesions on their back
    Interventions:
    • Procedure: Skin biopsy
    • Procedure: Blood draw
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 19, 2014)
34
Original Estimated Enrollment
 (submitted: August 21, 2013)
35
Actual Study Completion Date June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01929057
Other Study ID Numbers 121230
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Tissa Hata, MD, University of California, San Diego
Study Sponsor University of California, San Diego
Collaborators Not Provided
Investigators
Principal Investigator: Tissa Hata, MD UCSD
PRS Account University of California, San Diego
Verification Date October 2019