Extended Release Tacrolimus (Advagraf®) in Severe Adult Atopic Dermatitis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Reversal of Epidermal Phenotype in Severe Atopic Dermatitis With Cyclosporine Therapy

NCT01149759

Atopic Dermatitis Eczema

COMPLETED NA

An Efficacy and Safety Study of Tacrolimus Ointment in Adult Participants With Atopic Dermatitis

NCT01828879

Dermatitis, Atopic

COMPLETED PHASE4

Photophoresis Versus Ciclosporine in Severe Atopic Dermatitis

NCT02226068

Atopic Dermatitis

COMPLETED NA

Efficacy and Safety Study of QAW039 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis.

NCT01785602

Atopic Dermatitis

COMPLETED PHASE2

An Efficacy and Safety Study of Tacrolimus Ointment in Pediatric Participants With Atopic Dermatitis

NCT01782729

Dermatitis, Atopic

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atopic Dermatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Extended release tacrolimus (Advagraf®)

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Extended release tacrolimus (Advagraf®)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No