Atopic DermatitisNCT01789619
Extended Release Tacrolimus (Advagraf®) in Severe Adult Atopic Dermatitis Patients
An observational study of Atopic Dermatitis, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
To evaluate the clinical efficacy of the extended release formulation of tacrolimus (Advagraf®) in patients with severe atopic dermatitis, who can not be treated adequately with cyclosporine A because of side effects and/or non-responsiveness. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Extended release tacrolimus (Advagraf®)
- How many people
- 9 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2012to Jan 2014
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe atopic dermatitis, who can not be treated adequately with Cycloporin A because of side effects and/or non-responsiveness.
Who may be able to join
- Adult patients with severe atopic dermatitis, uncontrolled by topical treatment (indication for oral immunosuppressive drugs), who are unresponsive to Cyclosporin A, or in which treatment was discontinued because of side effects.
Who cannot join
- Concomitant use of other oral immunosuppressive drugs and/or UV light therapy
- Preexisting abnormalities in liver function, kidney function or haematological abnormalities
- History of malignancy within the last 5 years
- Uncontrolled hypertension
- Pregnancy or lactation; wish for pregnancy during the treatment period
- Infections requiring continued therapy
- Known positivity for HIV
- Evidence of drug and/or alcohol abuse
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Utrecht
Utrecht, Utrecht, 3584CX
About this study
To evaluate the clinical efficacy of the extended release formulation of tacrolimus (Advagraf®) in patients with severe atopic dermatitis, who can not be treated adequately with cyclosporine A because of side effects and/or non-responsiveness.
- Conditions
- Atopic Dermatitis
- Being tested
- Extended release tacrolimus (Advagraf®)
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended release tacrolimus (Advagraf®)Drug
| Study group | Role | What they receive |
|---|---|---|
| Extended release tacrolimus (Advagraf®) | Not described Receives: Drug: Extended release tacrolimus (Advagraf®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Scoring Atopic Dermatitis (SCORAD)
Clinical eczema scores
Measured: Every 4 weeks up to one year
Secondary outcomes (2)
Change in Patient-Oriented Eczema Measure (POEM)
Self administered eczema score
Measured: Every 4 weeks up to one year
Change in Thymus and Activation-Regulated Chemokine in serum (TARC)
Biomarker atopic dermatitis
Measured: Every 4 weeks up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr M.S. de Bruin-Weller, UMC Utrecht
- Investigators
- C AFM Bruijnzeel-Koomen, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789619
- Status last verified
- May 2015
- First submitted
- 6 Feb 2013
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Release Tacrolimus (Advagraf®) in Severe Adult Atopic Dermatitis Patients
- ClinicalTrials.gov ID
- NCT01789619
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 12 Feb 2013 (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.
To evaluate the clinical efficacy of the extended release formulation of tacrolimus (Advagraf®) in patients with severe atopic dermatitis, who can not be treated adequately with cyclosporine A because of side effects and/or non-responsiveness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extended release tacrolimus (Advagraf®) | – | Drug: Extended release tacrolimus (Advagraf®) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe atopic dermatitis, who can not be treated adequately with Cycloporin A because of side effects and/or non-responsiveness.
Key inclusion criteria (1 listed)
- Adult patients with severe atopic dermatitis, uncontrolled by topical treatment (indication for oral immunosuppressive drugs), who are unresponsive to Cyclosporin A, or in which treatment was discontinued because of side effects.
Key exclusion criteria (8 listed)
- Concomitant use of other oral immunosuppressive drugs and/or UV light therapy
- Preexisting abnormalities in liver function, kidney function or haematological abnormalities
- History of malignancy within the last 5 years
- Uncontrolled hypertension
- Pregnancy or lactation; wish for pregnancy during the treatment period
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 |
|---|---|---|
| Extended release tacrolimus (Advagraf®) | Drug | Extended release tacrolimus (Advagraf®) |
Primary outcome
Change in Scoring Atopic Dermatitis (SCORAD)
Time frame: Every 4 weeks up to one year
Clinical eczema scores
2 secondary outcomes
Change in Patient-Oriented Eczema Measure (POEM)
Time frame: Every 4 weeks up to one year
Change in Thymus and Activation-Regulated Chemokine in serum (TARC)
Time frame: Every 4 weeks up to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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.
C AFM Bruijnzeel-Koomen, MD, PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by UMC Utrecht at 1 site in Netherlands.
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 8 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: finished, as of the sponsor's last update on 29 May 2015. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Scoring Atopic Dermatitis (SCORAD) (time frame: Every 4 weeks up to one year). 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 29 May 2015.