Acne
Conditions
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.
Interventions
PROCEDURESkin biopsy
4-millimeter punch biopsies will be performed on all subjects (acne patients and healthy controls)
PROCEDUREBlood draw
Approximately half a tube of blood will be drawn from all participants in the study
Sponsors
University of California, San Diego
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of IL-1β | 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
| Measure | Time frame | Description |
|---|---|---|
| Level of Antibody to CAMP(Christie-Atkins-Munch-Petersen) Factor | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 31 |
| 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 | 3 |
| Total | 34 |
Baseline characteristics
| Characteristic | Acne Patients | Healthy Controls | Total |
|---|---|---|---|
| Age, Continuous | 26 years STANDARD_DEVIATION 6.7 | 26 years STANDARD_DEVIATION 2.3 | 26 years STANDARD_DEVIATION 6.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 0 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 3 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 31 participants | 3 participants | 34 participants |
| Sex: Female, Male Female | 17 Participants | 2 Participants | 19 Participants |
| Sex: Female, Male Male | 14 Participants | 1 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 3 |
| serious Total, serious adverse events | 0 / 31 | 0 / 3 |
Outcome results
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.
Time frame: post biopsy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Controls | Level of IL-1β | 52.5 pg/mg | Standard Deviation 15.6 |
| Acne Patients | Level of IL-1β | 361.2 pg/mg | Standard Deviation 60.3 |
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.
Time frame: post biopsy
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Healthy Controls | Level of Antibody to CAMP(Christie-Atkins-Munch-Petersen) Factor | 280 titers | Standard Error 99 |
| Acne Patients | Level of Antibody to CAMP(Christie-Atkins-Munch-Petersen) Factor | 625 titers | Standard Error 122 |