Study to Evaluate the Efficacy and Safety of 0.1% and 0.03% Tacrolimus Ointment Administered in Adults With Moderate to Severe Atopic Dermatitis

NCT ID: NCT00691145

Last Updated: 2014-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2005-02-28

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.

Detailed Description

The main phase is 6 months duration, but the follow up phase up to 12 months will allow the collection of efficacy and safety data in a period which will include all seasons in each patient, to account for seasonal variability which strongly affect atopic dermatitis course.

Conditions

Dermatitis, Atopic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

tacrolimus ointment

Intervention Type: DRUG

transdermal

Interventions

tacrolimus ointment

transdermal

Intervention Type: DRUG

Other Intervention Names

FK506 ointment

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Europe B.V.

Locations

S. Giovanni Rotondo, Foggia, Italy

Battipaglia, Salerno, Italy

Ancona, , Italy

Bari, , Italy

Benevento, , Italy

Bergamo, , Italy

Bolzano, , Italy

Catania, , Italy

Genova, , Italy

Mantova, , Italy

Merano, , Italy

Messina, , Italy

Milan, , Italy

Napoli, , Italy

Novara, , Italy

Parma, , Italy

Pavia, , Italy

Perugia, , Italy

Reggio Emilia, , Italy

Roma, , Italy

Roma, , Italy

Sassari, , Italy

Siena, , Italy

Torino, , Italy

Trieste, , Italy

Venezia, , Italy

Countries

Italy

Other Identifiers

FG-506-06-IT-01

Identifier Type: -

Identifier Source: org_study_id