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

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ClinicalTrials.gov Identifier: NCT01929057
Recruitment Status : Completed
First Posted : August 27, 2013
Results First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Tissa Hata, MD, University of California, San Diego

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition Acne
Interventions Procedure: Skin biopsy
Procedure: Blood draw
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Acne Patients Healthy Controls
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 31 3
Completed 31 3
Not Completed 0 0
Arm/Group Title Acne Patients Healthy Controls Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 31 3 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 3 participants 34 participants
26  (6.7) 26  (2.3) 26  (6.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 3 participants 34 participants
Female
17
  54.8%
2
  66.7%
19
  55.9%
Male
14
  45.2%
1
  33.3%
15
  44.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 3 participants 34 participants
Hispanic or Latino
5
  16.1%
0
   0.0%
5
  14.7%
Not Hispanic or Latino
25
  80.6%
3
 100.0%
28
  82.4%
Unknown or Not Reported
1
   3.2%
0
   0.0%
1
   2.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants 3 participants 34 participants
31 3 34
1.Primary Outcome
Title Level of IL-1β
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Controls Acne Patients
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 3 31
Overall Number of Units Analyzed
Type of Units Analyzed: Biopsies
3 31
Mean (Standard Deviation)
Unit of Measure: pg/mg
52.5  (15.6) 361.2  (60.3)
2.Secondary Outcome
Title Level of Antibody to CAMP(Christie-Atkins-Munch-Petersen) Factor
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acne Patients Healthy Controls
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 31 3
Geometric Mean (Standard Error)
Unit of Measure: titers
280  (99) 625  (122)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acne Patients Healthy Controls
Hide Arm/Group Description

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

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

All-Cause Mortality
Acne Patients Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Acne Patients Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acne Patients Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/3 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dermatology Clinical Trial Manage
Organization: UCSD Dermatology Clinical Trials
Phone: (858)657-8390
EMail: dermstudies@ucsd.edu
Layout table for additonal information
Responsible Party: Tissa Hata, MD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01929057     History of Changes
Other Study ID Numbers: 121230
First Submitted: August 21, 2013
First Posted: August 27, 2013
Results First Submitted: June 4, 2019
Results First Posted: October 3, 2019
Last Update Posted: October 3, 2019