Laboratory Characteristics in Chronic Atrophic Acrodermatitis

Chronic Atrophic Acrodermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02147262
• Other study ID #: ACA-0613
• Status: Recruiting
• Phase: N/A
• Start date: July 2013
• Est. completion date: July 2020

Study information

• Verified date: May 2018
• Source: University Medical Centre Ljubljana
• Contact: Dasa Stupica, MD, PhD
• Phone: +386 1 522 2110
• Email: cerar.dasa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• chronic atrophic dermatitis in patients >18 years

Exclusion Criteria:

Related Conditions & MeSH terms

• Atrophy
• Chronic Atrophic Acrodermatitis

Intervention

Drug:
• doxycycline orally, 100 mg, bid, 14 days

• doxycycline orally, 100 mg, bid, 28 days

Locations

Country	Name	City	State
Slovenia	UMC Ljubljana, Department of Infectious Diseases	Ljubljana

Sponsors (4)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	Harvard University, Medical University of Vienna, University of Ljubljana School of Medicine, Slovenia

Country where clinical trial is conducted

Slovenia, 

Outcome

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