search
Back to results

Laboratory Characteristics in Chronic Atrophic Acrodermatitis

Primary Purpose

Chronic Atrophic Acrodermatitis

Status
Unknown status
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
doxycycline orally, 100 mg, bid, 14 days
doxycycline orally, 100 mg, bid, 28 days
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Atrophic Acrodermatitis focused on measuring chronic atrophic acrodermatitis, Lyme borreliosis, molecular characteristics, outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • chronic atrophic dermatitis in patients >18 years

Exclusion Criteria:

  • none

Sites / Locations

  • UMC Ljubljana, Department of Infectious DiseasesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ACA-doxy 14 days

ACA-doxy 28 days

Arm Description

patients with chronic atrophic acrodermatitis treated with doxycycline for 14 days

patients with chronic atrophic acrodermatitis treated with doxycycline for 28 days

Outcomes

Primary Outcome Measures

inflammatory proteins in patients with chronic atrophic dermatitis
The inflammatory immune profiles will be assessed using Luminex to measure the expression of cytokines and chemokines representative of innate and adaptive TH1, TH2, TH17, and B cell responses.

Secondary Outcome Measures

clinical characteristics of patients with chronic atrophic dermatitis treated with doxycycline for 14 or 28 days

Full Information

First Posted
June 24, 2013
Last Updated
May 3, 2018
Sponsor
University Medical Centre Ljubljana
Collaborators
University of Ljubljana School of Medicine, Slovenia, Medical University of Vienna, Harvard University
search

1. Study Identification

Unique Protocol Identification Number
NCT02147262
Brief Title
Laboratory Characteristics in Chronic Atrophic Acrodermatitis
Official Title
Inflammatory Proteins,Gene Polymorphisms, and Transcriptome Profiles in Patients With Chronic Atrophic Acrodermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
Collaborators
University of Ljubljana School of Medicine, Slovenia, Medical University of Vienna, Harvard University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective of this study is to characterize the inflammatory proteins, gene polymorphisms, and transcriptome profiles in patients with chronic atrophic dermatitis to gain better insight into pathogenesis of chronic infection with Borrelia burgdorferi sensu lato.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Atrophic Acrodermatitis
Keywords
chronic atrophic acrodermatitis, Lyme borreliosis, molecular characteristics, outcome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACA-doxy 14 days
Arm Type
Active Comparator
Arm Description
patients with chronic atrophic acrodermatitis treated with doxycycline for 14 days
Arm Title
ACA-doxy 28 days
Arm Type
Active Comparator
Arm Description
patients with chronic atrophic acrodermatitis treated with doxycycline for 28 days
Intervention Type
Drug
Intervention Name(s)
doxycycline orally, 100 mg, bid, 14 days
Intervention Type
Drug
Intervention Name(s)
doxycycline orally, 100 mg, bid, 28 days
Primary Outcome Measure Information:
Title
inflammatory proteins in patients with chronic atrophic dermatitis
Description
The inflammatory immune profiles will be assessed using Luminex to measure the expression of cytokines and chemokines representative of innate and adaptive TH1, TH2, TH17, and B cell responses.
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
clinical characteristics of patients with chronic atrophic dermatitis treated with doxycycline for 14 or 28 days
Time Frame
at enrollment, at 2, 6 12 and 24 months follow-up
Other Pre-specified Outcome Measures:
Title
gene polymorphisms in patients with chronic atrophic dermatitis
Description
The expression of disease-relevant genomic variants will be assessed using ImmunoChip.
Time Frame
at enrollment, at 6 months follow-up
Title
transcriptome profiles in patients with chronic atrophic dermatitis
Description
We will use RNA sequencing of individual immune cell subtypes from patients to determine their transcriptome.
Time Frame
at enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: chronic atrophic dermatitis in patients >18 years Exclusion Criteria: none
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dasa Stupica, MD, PhD
Phone
+386 1 522 2110
Email
cerar.dasa@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Franc Strle, MD, PhD
Phone
+386 1 522 2610
Email
franc.strle@kclj.si
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franc Strle, MD, PhD
Organizational Affiliation
UMC Ljubljana
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dasa Stupica, MD, PhD
Organizational Affiliation
UMC Ljubljana
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMC Ljubljana, Department of Infectious Diseases
City
Ljubljana
ZIP/Postal Code
1525
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dasa Stupica, MD,PhD
Phone
+386 1 522 2110
Email
cerar.dasa@gmail.com
First Name & Middle Initial & Last Name & Degree
Franc Strle, MD,PhD
Phone
+386 1 522 2610
Email
franc.strle@kclj.si

12. IPD Sharing Statement

Learn more about this trial

Laboratory Characteristics in Chronic Atrophic Acrodermatitis

We'll reach out to this number within 24 hrs