Chronic Atrophic AcrodermatitisNCT02147262
Laboratory Characteristics in Chronic Atrophic Acrodermatitis
A study testing doxycycline orally, 100 mg, bid, 14 days and doxycycline orally, 100 mg, bid, 28 days in people with Chronic Atrophic Acrodermatitis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Atrophic Acrodermatitis
- What is being tested?
- doxycycline orally, 100 mg, bid, 14 days and doxycycline orally, 100 mg, bid, 28 days
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSlovenia
- Study dates
- Jul 2013to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic atrophic dermatitis in patients >18 years
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
UMC Ljubljana, Department of Infectious Diseases
Ljubljana, 1525
Dasa Stupica, MD,PhD, +386 1 522 2110, cerar.dasa@gmail.com
Franc Strle, MD,PhD, +386 1 522 2610, franc.strle@kclj.si
About this study
Official title: Inflammatory Proteins,Gene Polymorphisms, and Transcriptome Profiles in Patients With Chronic Atrophic Acrodermatitis
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.
- Conditions
- Chronic Atrophic Acrodermatitis
- Being tested
- doxycycline orally, 100 mg, bid, 14 days, doxycycline orally, 100 mg, bid, 28 days
- Keywords
- chronic atrophic acrodermatitis, Lyme borreliosis, molecular characteristics, outcome
- Medical subject headings
- Lyme Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxycycline orally, 100 mg, bid, 14 daysDrug
doxycycline orally, 100 mg, bid, 28 daysDrug
| Study group | Role | What they receive |
|---|---|---|
| ACA-doxy 14 days | Active comparator | patients with chronic atrophic acrodermatitis treated with doxycycline for 14 days Receives: Drug: doxycycline orally, 100 mg, bid, 14 days |
| ACA-doxy 28 days | Active comparator | patients with chronic atrophic acrodermatitis treated with doxycycline for 28 days Receives: Drug: doxycycline orally, 100 mg, bid, 28 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 months
Secondary outcomes (1)
clinical characteristics of patients with chronic atrophic dermatitis treated with doxycycline for 14 or 28 days
Measured: at enrollment, at 2, 6 12 and 24 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startJul 2013
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Atrophic AcrodermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana School of Medicine, Slovenia, Medical University of Vienna, Harvard University
- Responsible party
- Principal investigator, Franc Strle, University Medical Centre Ljubljana
- Investigators
- Franc Strle, MD, PhD, Study chair, UMC LjubljanaDasa Stupica, MD, PhD, Principal investigator, UMC Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147262
- Sponsor's protocol ID
- ACA-0613
- Status last verified
- May 2018
- First submitted
- 24 Jun 2013
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Proteins,Gene Polymorphisms, and Transcriptome Profiles in Patients With Chronic Atrophic Acrodermatitis
- ClinicalTrials.gov ID
- NCT02147262
- Acronym / sponsor ID
- ACA-0613
- Conditions
- Chronic Atrophic Acrodermatitis
- Keywords
- chronic atrophic acrodermatitis, Lyme borreliosis, molecular characteristics, outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- University of Ljubljana School of Medicine, Slovenia, Medical University of Vienna, Harvard University
- Study start
- Jul 2013
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 26 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACA-doxy 14 days | Active comparator | Drug: doxycycline orally, 100 mg, bid, 14 dayspatients with chronic atrophic acrodermatitis treated with doxycycline for 14 days |
| ACA-doxy 28 days | Active comparator | Drug: doxycycline orally, 100 mg, bid, 28 dayspatients with chronic atrophic acrodermatitis treated with doxycycline for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chronic atrophic dermatitis in patients >18 years
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| doxycycline orally, 100 mg, bid, 14 days | Drug | ACA-doxy 14 days |
| doxycycline orally, 100 mg, bid, 28 days | Drug | ACA-doxy 28 days |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
Related trials for Chronic Atrophic Acrodermatitis
Active, not recruitingObservational study
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Spinal Muscular Atrophy, Fragile X Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franc Strle, MD, PhD study chair
UMC Ljubljana
Dasa Stupica, MD, PhD principal investigator
UMC Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing doxycycline orally, 100 mg, bid, 14 days and doxycycline orally, 100 mg, bid, 28 days in people with Chronic Atrophic Acrodermatitis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dasa Stupica, MD, PhD (+386 1 522 2110, cerar.dasa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflammatory proteins in patients with chronic atrophic dermatitis (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.