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

NCT01929057 | Completed Results

• 1 other identifier: 121230
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Level of IL-1β

  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.

  post biopsy

Secondary Outcomes (1)

• Level of Antibody to CAMP(Christie-Atkins-Munch-Petersen) Factor

  post biopsy

Study Arms (2)

Acne patients

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

Procedure: Skin biopsy; Procedure: Blood draw

Healthy Controls

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

Procedure: Skin biopsy; Procedure: Blood draw

Interventions

Skin biopsy PROCEDURE

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

Acne patients; Healthy Controls

Blood draw PROCEDURE

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

Acne patients; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

community sample

You may qualify if:

• Fits into one of the following diagnostic groups:
• Healthy subject with no active skin disease or history of skin disease
• 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
• 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

You may not qualify if:

• Subjects with severe medical condition(s) that in the view of the investigator prohibits participation in the study
• Subject has Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
• Pregnant or nursing females
• 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.
• 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
• 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)
• Active viral or fungal skin infections at the target areas
• Are currently receiving lithium now or within the last 4 weeks.
• Ongoing participation in an investigational drug trial
• Use of any systemic immunosuppressive therapy less than four weeks prior to screening.
• Subjects with diabetes
• Injured, broken skin that, per the investigator, may lead to poor wound healing
• Subjects with allergies to anesthetic medications

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Division of Dermatology

San Diego, California, 92122, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dermatology Clinical Trial Manage
• Organization: UCSD Dermatology Clinical Trials

dermstudies@ucsd.edu

(858)657-8390

Study Officials

• Tissa Hata, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: August 27, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 3, 2019
• Results First Posted: October 3, 2019

Record last verified: 2019-10

Locations

US (1)