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

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.

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Drug: tacrolimus ointment

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.

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Ancona, Italy, 60020
  • Bari, Italy, 70124
  • Benevento, Italy, 82100
  • Bergamo, Italy, 24100
  • Bolzano, Italy, 39100
  • Catania, Italy, 95124
  • Genova, Italy, 16132
  • Mantova, Italy, 46100
  • Merano, Italy, 39102
  • Messina, Italy, 98100
  • Milano, Italy, 20100
  • Napoli, Italy, 80100
  • Novara, Italy, 28100
  • Parma, Italy, 43100
  • Pavia, Italy, 27100
  • Perugia, Italy, 06100
  • Reggio Emilia, Italy, 42100
  • Roma, Italy, 00133
  • Roma, Italy, 00141
  • Sassari, Italy, 07100
  • Siena, Italy, 53100
  • Torino, Italy, 10126
  • Trieste, Italy, 34149
  • Venezia, Italy, 30122
  • Foggia
    • S. Giovanni Rotondo, Foggia, Italy, 71013
  • Salerno
    • Battipaglia, Salerno, Italy, 84091

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1	Drug: tacrolimus ointment; transdermal; Other Names: FK506 ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Publications and helpful links

Helpful Links

• Link to Results on JAPIC - enter 140568 in the JapicCTI-RNo. field

Study record dates

Study Major Dates

• Study Start: October 1, 2002
• Primary Completion (ACTUAL): February 1, 2005
• Study Completion (ACTUAL): February 1, 2005

Study Registration Dates

• First Submitted: June 3, 2008
• First Submitted That Met QC Criteria: June 4, 2008
• First Posted (ESTIMATE): June 5, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): September 1, 2014
• Last Update Submitted That Met QC Criteria: August 28, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Atopic dermatitis; Tacrolimus ointment
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: FG-506-06-IT-01