Trial Outcomes & Findings for Evaluation of the Role of Propionibacterium Acnes in the Inflammatory Lesions Associated With Acne Vulgaris (NCT NCT01929057)

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

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

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=93 Participants	26 years STANDARD_DEVIATION 2.3 • n=4 Participants	26 years STANDARD_DEVIATION 6.4 • n=27 Participants
Sex: Female, Male Female	17 Participants n=93 Participants	2 Participants n=4 Participants	19 Participants n=27 Participants
Sex: Female, Male Male	14 Participants n=93 Participants	1 Participants n=4 Participants	15 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=93 Participants	0 Participants n=4 Participants	5 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=93 Participants	3 Participants n=4 Participants	28 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	31 participants n=93 Participants	3 participants n=4 Participants	34 participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

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 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.

Outcome measures

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