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Laboratory Characteristics in Chronic Atrophic Acrodermatitis

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ClinicalTrials.gov Identifier: NCT02147262
Recruitment Status : Unknown
Verified May 2018 by Franc Strle, University Medical Centre Ljubljana.
Recruitment status was:  Recruiting
First Posted : May 26, 2014
Last Update Posted : May 4, 2018
Sponsor:
Collaborators:
University of Ljubljana School of Medicine, Slovenia
Medical University of Vienna
Harvard University
Information provided by (Responsible Party):
Franc Strle, University Medical Centre Ljubljana

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Atrophic Acrodermatitis Drug: doxycycline orally, 100 mg, bid, 14 days Drug: doxycycline orally, 100 mg, bid, 28 days Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Inflammatory Proteins,Gene Polymorphisms, and Transcriptome Profiles in Patients With Chronic Atrophic Acrodermatitis
Study Start Date : July 2013
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 Outcome Measures:
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic atrophic dermatitis in patients >18 years

Exclusion Criteria:

  • none
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147262


Contacts
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Contact: Dasa Stupica, MD, PhD +386 1 522 2110 cerar.dasa@gmail.com
Contact: Franc Strle, MD, PhD +386 1 522 2610 franc.strle@kclj.si

Locations
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Slovenia
UMC Ljubljana, Department of Infectious Diseases Recruiting
Ljubljana, Slovenia, 1525
Contact: Dasa Stupica, MD,PhD    +386 1 522 2110    cerar.dasa@gmail.com   
Contact: Franc Strle, MD,PhD    +386 1 522 2610    franc.strle@kclj.si   
Sponsors and Collaborators
University Medical Centre Ljubljana
University of Ljubljana School of Medicine, Slovenia
Medical University of Vienna
Harvard University
Investigators
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Study Chair: Franc Strle, MD, PhD UMC Ljubljana
Principal Investigator: Dasa Stupica, MD, PhD UMC Ljubljana
More Information
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Responsible Party: Franc Strle, M.D., PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02147262    
Other Study ID Numbers: ACA-0613
First Posted: May 26, 2014    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Keywords provided by Franc Strle, University Medical Centre Ljubljana:
chronic atrophic acrodermatitis
Lyme borreliosis
molecular characteristics
outcome
Additional relevant MeSH terms:
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Acrodermatitis
Atrophy
Pathological Conditions, Anatomical
Skin Abnormalities
Congenital Abnormalities
Dermatitis
Skin Diseases
 Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents