Trial Outcomes & Findings for Evaluation of the Role of Propionibacterium Acnes in the Inflammatory Lesions Associated With Acne Vulgaris (NCT NCT01929057)
NCT ID: NCT01929057
Last Updated: 2019-10-03
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
34 participants
Primary outcome timeframe
post biopsy
Results posted on
2019-10-03
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
3
|
|
Overall Study
COMPLETED
|
31
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Role of Propionibacterium Acnes in the Inflammatory Lesions Associated With Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Acne Patients
n=31 Participants
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
|
Healthy Controls
n=3 Participants
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
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26 years
STANDARD_DEVIATION 6.7 • n=99 Participants
|
26 years
STANDARD_DEVIATION 2.3 • n=107 Participants
|
26 years
STANDARD_DEVIATION 6.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=99 Participants
|
3 participants
n=107 Participants
|
34 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: post biopsyThe 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.
Outcome measures
| Measure |
Healthy Controls
n=3 Biopsies
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
|
Acne Patients
n=31 Biopsies
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
|
|---|---|---|
|
Level of IL-1β
|
52.5 pg/mg
Standard Deviation 15.6
|
361.2 pg/mg
Standard Deviation 60.3
|
SECONDARY outcome
Timeframe: post biopsyAntibody 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.
Outcome measures
| Measure |
Healthy Controls
n=31 Participants
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
|
Acne Patients
n=3 Participants
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
|
|---|---|---|
|
Level of Antibody to CAMP(Christie-Atkins-Munch-Petersen) Factor
|
280 titers
Standard Error 99
|
625 titers
Standard Error 122
|
Adverse Events
Acne Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dermatology Clinical Trial Manage
UCSD Dermatology Clinical Trials
Phone: (858)657-8390
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place