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Cytokines in Papillon-Lefèvre Syndrome

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ClinicalTrials.gov Identifier: NCT01116934
Recruitment Status : Completed
First Posted : May 5, 2010
Results First Posted : March 24, 2016
Last Update Posted : March 24, 2016
Sponsor:
Information provided by (Responsible Party):
Peter Eickholz, Goethe University

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Cross-Sectional
Condition Papillon-Lefevre Disease
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Papillon-Lefèvre Syndrome (PLS) Patients Healthy Controls
Hide Arm/Group Description 8 PLS patients (one female) from 6 families 9 healthy donors
Period Title: Overall Study
Started 8 9
Completed 8 9
Not Completed 0 0
Arm/Group Title PLS Patients Healthy Controls Total
Hide Arm/Group Description 8 PLS patients (one female) from 6 families 9 healthy donors Total of all reporting groups
Overall Number of Baseline Participants 8 9 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 17 participants
<=18 years
5
  62.5%
0
   0.0%
5
  29.4%
Between 18 and 65 years
3
  37.5%
9
 100.0%
12
  70.6%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 17 participants
Female
1
  12.5%
0
   0.0%
1
   5.9%
Male
7
  87.5%
9
 100.0%
16
  94.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 8 participants 9 participants 17 participants
8 9 17
1.Primary Outcome
Title Serum Concentrations of Interleukin (IL)-1 Beta
Hide Description Concentrations of IL-8, IL-6, IP-10, interferon (IFN)-gamma, and IL-1 beta, in plasma/RPMI samples were determined by enzyme linked immunosorbent assay (ELISA) according to the manufacturers’ instructions
Time Frame 2006
Hide Outcome Measure Data
Hide Analysis Population Description
Samples were stimulated with 100 ng/ml lipopolysaccharide (LPS)
Arm/Group Title Papillon-Lefèvre Syndrome (PLS) Patients Healthy Controls
Hide Arm/Group Description:
8 PLS patients (one female) from 6 families
9 healthy donors
Overall Number of Participants Analyzed 8 9
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
interleukin-1 beta
1100.00
(896.21 to 2572.10)
896.21
(771.15 to 2014.00)
interleukin-6
65559
(40365 to 108260)
45734
(34056 to 66365)
interferon-inducible protein-10
12902.5
(8105.5 to 15735.5)
11563
(9164 to 19758)
interferon gamma
3704.5
(2629.5 to 4372.8)
3317.4
(2538.5 to 5487.8)
interleukin-8
50520
(29280 to 79870)
44390
(24680 to 46580)
Time Frame Patients were asked to report AEs from blood sampling if they occured.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PLS Patients Healthy Controls
Hide Arm/Group Description 8 PLS patients (one female) from 6 families 9 healthy donors
All-Cause Mortality
PLS Patients Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PLS Patients Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PLS Patients Healthy Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/9 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Prof. Dr. Peter Eickholz
Organization: JWGUniversity
Phone: +49-69-6301 ext 5642
Responsible Party: Peter Eickholz, Goethe University
ClinicalTrials.gov Identifier: NCT01116934     History of Changes
Other Study ID Numbers: PLS-Cytokines
First Submitted: May 3, 2010
First Posted: May 5, 2010
Results First Submitted: June 1, 2015
Results First Posted: March 24, 2016
Last Update Posted: March 24, 2016