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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00691145
First received: June 3, 2008
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Dermatitis, Atopic
Drug: tacrolimus ointment
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The incidence of adverse events during the study, including all clinically significant laboratory values [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 350
Study Start Date: October 2002
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tacrolimus ointment
transdermal
Other Name: FK506 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691145

Locations
Italy
S. Giovanni Rotondo, Foggia, Italy, 71013
Battipaglia, Salerno, Italy, 84091
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
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Central Contact Astellas Pharma Europe B.V.
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00691145     History of Changes
Other Study ID Numbers: FG-506-06-IT-01
Study First Received: June 3, 2008
Last Updated: August 28, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Astellas Pharma Inc:
Atopic dermatitis
Tacrolimus ointment

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Tacrolimus
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014