Trial Outcomes & Findings for Cytokines in Papillon-Lefèvre Syndrome (NCT NCT01116934)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

17 participants

Primary outcome timeframe

2006

Results posted on

2016-03-24

Participant Flow

Participant milestones

Participant milestones
Measure	Papillon-Lefèvre Syndrome (PLS) Patients 8 PLS patients (one female) from 6 families	Healthy Controls 9 healthy donors
Overall Study STARTED	8	9
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cytokines in Papillon-Lefèvre Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PLS Patients n=8 Participants 8 PLS patients (one female) from 6 families	Healthy Controls n=9 Participants 9 healthy donors	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment Germany	8 participants n=5 Participants	9 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 2006

Population: Samples were stimulated with 100 ng/ml lipopolysaccharide (LPS)

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

Outcome measures

Outcome measures
Measure	Papillon-Lefèvre Syndrome (PLS) Patients n=8 Participants 8 PLS patients (one female) from 6 families	Healthy Controls n=9 Participants 9 healthy donors
Serum Concentrations of Interleukin (IL)-1 Beta interleukin-1 beta	1100.00 pg/ml Interval 896.21 to 2572.1	896.21 pg/ml Interval 771.15 to 2014.0
Serum Concentrations of Interleukin (IL)-1 Beta interleukin-6	65559 pg/ml Interval 40365.0 to 108260.0	45734 pg/ml Interval 34056.0 to 66365.0
Serum Concentrations of Interleukin (IL)-1 Beta interferon-inducible protein-10	12902.5 pg/ml Interval 8105.5 to 15735.5	11563 pg/ml Interval 9164.0 to 19758.0
Serum Concentrations of Interleukin (IL)-1 Beta interferon gamma	3704.5 pg/ml Interval 2629.5 to 4372.8	3317.4 pg/ml Interval 2538.5 to 5487.8
Serum Concentrations of Interleukin (IL)-1 Beta interleukin-8	50520 pg/ml Interval 29280.0 to 79870.0	44390 pg/ml Interval 24680.0 to 46580.0

Adverse Events

PLS 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

Prof. Dr. Peter Eickholz

JWGUniversity

Phone: +49-69-6301

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place