Laboratory Characteristics in Chronic Atrophic Acrodermatitis

May 3, 2018 updated by: Franc Strle, University Medical Centre Ljubljana

Inflammatory Proteins,Gene Polymorphisms, and Transcriptome Profiles in Patients With Chronic Atrophic Acrodermatitis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1525
        • Recruiting
        • UMC Ljubljana, Department of Infectious Diseases
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • chronic atrophic dermatitis in patients >18 years

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ACA-doxy 14 days
patients with chronic atrophic acrodermatitis treated with doxycycline for 14 days
Drug: doxycycline orally, 100 mg, bid, 14 days
Active Comparator: ACA-doxy 28 days
patients with chronic atrophic acrodermatitis treated with doxycycline for 28 days
Drug: doxycycline orally, 100 mg, bid, 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
inflammatory proteins in patients with chronic atrophic dermatitis
Time Frame: up to 24 months
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.
up to 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
at enrollment, at 2, 6 12 and 24 months follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
gene polymorphisms in patients with chronic atrophic dermatitis
Time Frame: at enrollment, at 6 months follow-up
The expression of disease-relevant genomic variants will be assessed using ImmunoChip.
at enrollment, at 6 months follow-up
transcriptome profiles in patients with chronic atrophic dermatitis
Time Frame: at enrollment
We will use RNA sequencing of individual immune cell subtypes from patients to determine their transcriptome.
at enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Collaborators

Medical University of Vienna
Harvard University
University of Ljubljana School of Medicine, Slovenia

Investigators

  • Study Chair: Franc Strle, MD, PhD, UMC Ljubljana
  • Principal Investigator: Dasa Stupica, MD, PhD, UMC Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

June 24, 2013

First Submitted That Met QC Criteria

May 23, 2014

First Posted (Estimate)

May 26, 2014

Study Record Updates

Last Update Posted (Actual)

May 4, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACA-0613

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Atrophic Acrodermatitis

Clinical Trials on doxycycline orally, 100 mg, bid, 14 days

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe