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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acne patients | This group consists of patients who have at least moderate to severe acne on their back |
| |
| Healthy Controls | This group contains participants who do not have any active acne lesions on their back |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin biopsy | Procedure | 4-millimeter punch biopsies will be performed on all subjects (acne patients and healthy controls) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Fits into one of the following diagnostic groups:
Exclusion Criteria:
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community sample
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| Name | Affiliation | Role |
|---|---|---|
| Tissa Hata, MD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Division of Dermatology | San Diego | California | 92122 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acne Patients | This group consists of patients who have at least moderate to severe acne on their back 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 |
| FG001 | Healthy Controls | This group contains participants who do not have any active acne lesions on their back 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acne Patients | This group consists of patients who have at least moderate to severe acne on their back 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | pg/mg | post biopsy | Biopsies | Biopsies |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acne Patients | This group consists of patients who have at least moderate to severe acne on their back 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dermatology Clinical Trial Manage | UCSD Dermatology Clinical Trials | (858)657-8390 | dermstudies@ucsd.edu |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Blood draw | Procedure | Approximately half a tube of blood will be drawn from all participants in the study |
|
| post biopsy |
| Healthy Controls |
This group contains participants who do not have any active acne lesions on their back 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | Posted | Geometric Mean | Standard Error | titers | post biopsy |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Healthy Controls | This group contains participants who do not have any active acne lesions on their back 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 | 0 | 3 | 0 | 3 |
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| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |