Laboratory Characteristics in Chronic Atrophic Acrodermatitis

Overview

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.

Full Title of Study: “Inflammatory Proteins,Gene Polymorphisms, and Transcriptome Profiles in Patients With Chronic Atrophic Acrodermatitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2020

Interventions

  • Drug: doxycycline orally, 100 mg, bid, 14 days
  • Drug: doxycycline orally, 100 mg, bid, 28 days

Arms, Groups and Cohorts

  • Active Comparator: ACA-doxy 14 days
    • patients with chronic atrophic acrodermatitis treated with doxycycline for 14 days
  • Active Comparator: ACA-doxy 28 days
    • patients with chronic atrophic acrodermatitis treated with doxycycline for 28 days

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • chronic atrophic dermatitis in patients >18 years Exclusion Criteria:

  • none

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Medical Centre Ljubljana
  • Collaborator
    • University of Ljubljana School of Medicine, Slovenia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Franc Strle, M.D., PhD – University Medical Centre Ljubljana
  • Overall Official(s)
    • Franc Strle, MD, PhD, Study Chair, UMC Ljubljana
    • Dasa Stupica, MD, PhD, Principal Investigator, UMC Ljubljana
  • Overall Contact(s)
    • Dasa Stupica, MD, PhD, +386 1 522 2110, cerar.dasa@gmail.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.