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

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929057
• Other study ID #: 121230
• Status: Completed
• Start date: August 2013
• Est. completion date: June 2014

Study information

• Verified date: October 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Procedure:
• Skin biopsy
4-millimeter punch biopsies will be performed on all subjects (acne patients and healthy controls)
• Blood draw
Approximately half a tube of blood will be drawn from all participants in the study

Locations

Country	Name	City	State
United States	UCSD Division of Dermatology	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of IL-1ß	The amount of IL-1ß, an inflammatory marker, is measured in skin biopsies obtained from healthy patients and compared with levels in biopsies of acne lesions.	post biopsy
Secondary	Level of Antibody to CAMP(Christie-Atkins-Munch-Petersen) Factor	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.	post biopsy