Laboratory Characteristics in Chronic Atrophic Acrodermatitis
Inflammatory Proteins,Gene Polymorphisms, and Transcriptome Profiles in Patients With Chronic Atrophic Acrodermatitis
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedFirst Posted
Study publicly available on registry
May 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedMay 4, 2018
May 1, 2018
7 years
June 24, 2013
May 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
up to 24 months
Secondary Outcomes (1)
clinical characteristics of patients with chronic atrophic dermatitis treated with doxycycline for 14 or 28 days
at enrollment, at 2, 6 12 and 24 months follow-up
Other Outcomes (2)
gene polymorphisms in patients with chronic atrophic dermatitis
at enrollment, at 6 months follow-up
transcriptome profiles in patients with chronic atrophic dermatitis
at enrollment
Study Arms (2)
ACA-doxy 14 days
ACTIVE COMPARATORpatients with chronic atrophic acrodermatitis treated with doxycycline for 14 days
ACA-doxy 28 days
ACTIVE COMPARATORpatients with chronic atrophic acrodermatitis treated with doxycycline for 28 days
Interventions
Eligibility Criteria
You may qualify if:
- chronic atrophic dermatitis in patients \>18 years
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Medical Centre Ljubljanalead
- University of Ljubljana School of Medicine, Sloveniacollaborator
- Medical University of Viennacollaborator
- Harvard Universitycollaborator
Study Sites (1)
UMC Ljubljana, Department of Infectious Diseases
Ljubljana, 1525, Slovenia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Franc Strle, MD, PhD
UMC Ljubljana
- PRINCIPAL INVESTIGATOR
Dasa Stupica, MD, PhD
UMC Ljubljana
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., PhD
Study Record Dates
First Submitted
June 24, 2013
First Posted
May 26, 2014
Study Start
July 1, 2013
Primary Completion
July 1, 2020
Study Completion
July 1, 2020
Last Updated
May 4, 2018
Record last verified: 2018-05