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Laboratory Characteristics in Chronic Atrophic Acrodermatitis

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ClinicalTrials.gov Identifier: NCT02147262
Recruitment Status : 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

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 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


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



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.



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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:


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

Responsible Party: Franc Strle, M.D., PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02147262     History of Changes
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:
Skin Abnormalities
Skin Diseases
Atrophy
Acrodermatitis
Pathological Conditions, Anatomical
Congenital Abnormalities
Dermatitis
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents