CompletedNCT01929057Updated Oct 3, 2019Results posted

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

An observational study in Acne, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-03.

Sponsored by University of California, San Diego · Observational

Study type: Observational
Model: Cohort
Time perspective: Cross-sectional
Enrollment: 34
Ages: 18 Years to 60 Years
Sex: All

Study 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.

Conditions studied

Acne

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Acne Vulgaris 730

In context

Acne Vulgaris

730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.

This study's enrollment of 34 is below the median of 90 across 81 observational studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

Study population

community sample

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

Exclusion Criteria:

Subjects with severe medical condition(s) that in the view of the investigator prohibits participation in the study
Subject has Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
Pregnant or nursing females
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.
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
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)
Active viral or fungal skin infections at the target areas
Are currently receiving lithium now or within the last 4 weeks.
Ongoing participation in an investigational drug trial
Use of any systemic immunosuppressive therapy less than four weeks prior to screening.
Subjects with diabetes
Injured, broken skin that, per the investigator, may lead to poor wound healing
Subjects with allergies to anesthetic medications

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Enrollment: 34 participants (actual)
Patient registry: No

Groups and cohorts

Acne patients
This group consists of patients who have at least moderate to severe acne on their back
Procedure: Skin biopsy · Procedure: Blood draw
Healthy Controls
This group contains participants who do not have any active acne lesions on their back
Procedure: Skin biopsy · Procedure: Blood draw

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

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Results

Posted Oct 3, 2019

Participant flow

Participant flow — Overall Study
Milestone	Acne Patients	Healthy Controls
Started	31	3
Completed	31	3
Not completed	0	0

Outcome measures

PrimaryLevel 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
Reported as:: Mean · pg/mg

Level of IL-1β
pg/mg	Healthy Controls	Acne Patients
Level of IL-1β	52.5 ± 15.6	361.2 ± 60.3

SecondaryLevel 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
Reported as:: Geometric mean · titers

Level of Antibody to CAMP(Christie-Atkins-Munch-Petersen) Factor
titers	Acne Patients	Healthy Controls
Level of Antibody to CAMP(Christie-Atkins-Munch-Petersen) Factor	280 ± 99	625 ± 122

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Acne Patients	—	0/31 (0%)	0/31 (0%)
Healthy Controls	—	0/3 (0%)	0/3 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Acne Patients	Healthy Controls	Total
Mean	26 ± 6.7	26 ± 2.3	26 ± 6.4

Sex: Female, Male
Sex: Female, Male(Participants)	Acne Patients	Healthy Controls	Total
Female	17	2	19
Male	14	1	15

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Acne Patients	Healthy Controls	Total
Hispanic or Latino	5	0	5
Not Hispanic or Latino	25	3	28
Unknown or Not Reported	1	0	1

Region of Enrollment
Region of Enrollment(participants)	Acne Patients	Healthy Controls	Total
United States	31	3	34

Study locations

1 site

UCSD Division of Dermatology
San Diego, California 92122, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01929057
Lead sponsor: University of California, San Diego
Responsible party: Tissa Hata, MD (MD, University of California, San Diego) — Principal investigator
First posted: Aug 27, 2013
Start date: Aug 2013
Primary completion: Jun 2014
Completion: Jun 2014
Results posted: Oct 3, 2019
Last update: Oct 3, 2019

Study contacts

Tissa Hata, MD

principal investigator · UCSD

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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