Study to Evaluate the Efficacy and Safety of 0.1% and 0.03% Tacrolimus Ointment Administered in Adults With Moderate to Severe Atopic Dermatitis
A Long-term, Non-comparative, Multi-centre Study to Evaluate the Efficacy and Safety of 0.1% and 0.03% Tacrolimus (FK506) Ointment Administered in Adults With Moderate to Severe Atopic Dermatitis FG-506-06-IT-01
1 other identifier
interventional
350
1 country
26
Brief Summary
The objective of this study is to assess the efficacy and safety of 0.1% and 0.03% Tacrolimus ointment for 12 months in adults with moderate to severe atopic dermatitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2002
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 3, 2008
CompletedFirst Posted
Study publicly available on registry
June 5, 2008
CompletedSeptember 1, 2014
August 1, 2014
2.3 years
June 3, 2008
August 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The rate of patients with at least 50% (i.e. at least moderate) improvement according to the physician's global evaluation of clinical response at month 6/end of study (if before month 6) visit
1 year
Secondary Outcomes (3)
The rate of patients with at least 50%(i.e. at least moderate) improvement according to the physician's global evaluation of clinical response at month 12/end of study (if after month 6) visit
1 year
The rate of patients with at least 60% improvement in the Score In Atopic Dermatitis (SCORAD) at month 6/end of study visit (if before month 6) and at month 12/end of study (if after month 6) visit, each compared to baseline (day 1)
1 year
The incidence of adverse events during the study, including all clinically significant laboratory values
1 year
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patient may be male or female of any ethnic group
- Patient without restricted legal competence, and suffers from moderate to severe atopic dermatitis (Rajka/Langeland score of at least 4.5)
- Patient known to be responsive to topical steroids
- Patient is capable of understanding the purposes and risks of the trial and has given written Informed Consent
- Female patients of childbearing potential must agree to maintain adequate birth control practice during the trial period and during the first four weeks after the end of the study
- Patient meets the following criteria:
- Topical corticosteroids
- Systemic corticosteroids (for the treatment of AD only)
- Systemic non-steroidal immunosuppressants (e.g. cyclosporine, methotrexate)
- Other investigational drugs
- Light Treatments (UVA, UVB)
- Patient has not taken and agrees not to take for the complete study period any medication or therapy prohibited by the protocol
You may not qualify if:
- Patient has a genetic epidermal barrier defect such as Netherton's syndrome or generalised erythroderma
- Patient is pregnant or breast-feeding
- Patient has a skin infection on the affected (and to be treated) area
- Patient has a known hypersensitivity to macrolides in general, to tacrolimus or any excipient of the ointment
- Patient is simultaneously participating in any other drug trial or less than 28 days have passed between the end of the previous trial and this one
- Any form of substance abuse (including drug or alcohol abuse),psychiatric disorder or condition which, in the opinion of the investigator, may invalidate the communication with the investigator
- Patient is known to be HIV positive
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Unknown Facility
S. Giovanni Rotondo, Foggia, 71013, Italy
Unknown Facility
Battipaglia, Salerno, 84091, Italy
Unknown Facility
Ancona, 60020, Italy
Unknown Facility
Bari, 70124, Italy
Unknown Facility
Benevento, 82100, Italy
Unknown Facility
Bergamo, 24100, Italy
Unknown Facility
Bolzano, 39100, Italy
Unknown Facility
Catania, 95124, Italy
Unknown Facility
Genova, 16132, Italy
Unknown Facility
Mantova, 46100, Italy
Unknown Facility
Merano, 39102, Italy
Unknown Facility
Messina, 98100, Italy
Unknown Facility
Milan, 20100, Italy
Unknown Facility
Napoli, 80100, Italy
Unknown Facility
Novara, 28100, Italy
Unknown Facility
Parma, 43100, Italy
Unknown Facility
Pavia, 27100, Italy
Unknown Facility
Perugia, 06100, Italy
Unknown Facility
Reggio Emilia, 42100, Italy
Unknown Facility
Roma, 00133, Italy
Unknown Facility
Roma, 00141, Italy
Unknown Facility
Sassari, 07100, Italy
Unknown Facility
Siena, 53100, Italy
Unknown Facility
Torino, 10126, Italy
Unknown Facility
Trieste, 34149, Italy
Unknown Facility
Venezia, 30122, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Central Contact
Astellas Pharma Europe B.V.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2008
First Posted
June 5, 2008
Study Start
October 1, 2002
Primary Completion
February 1, 2005
Study Completion
February 1, 2005
Last Updated
September 1, 2014
Record last verified: 2014-08