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

• 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: University of California, San Diego
• Information provided by (Responsible Party): Tissa Hata, MD, University of California, San Diego

Study Description

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.

Condition or disease	Intervention/treatment
Acne	Procedure: Skin biopsy; Procedure: Blood draw

Study Design

• Study Type: Observational
• Actual Enrollment: 34 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Evaluation of the Role of Propionibacterium Acnes in the Inflammatory Lesions Associated With Acne Vulgaris
• Study Start Date: August 2013
• Actual Primary Completion Date: June 2014
• Actual Study Completion Date: June 2014

Groups and Cohorts

Group/Cohort	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Tissa Hata, MD, MD, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT01929057
• Other Study ID Numbers: 121230
• First Posted: August 27, 2013
• Results First Posted: October 3, 2019
• Last Update Posted: October 3, 2019
• Last Verified: October 2019

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases