ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00691145
Recruitment Status : Completed
First Posted : June 5, 2008
Last Update Posted : September 1, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: tacrolimus ointment Phase 3

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  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2002
Actual Primary Completion Date : February 2005
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: 1 Drug: tacrolimus ointment
transdermal
Other Name: FK506 ointment




Primary Outcome Measures :
  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 [ Time Frame: 1 year ]

Secondary Outcome Measures :
  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 12/end of study (if after month 6) visit [ Time Frame: 1 year ]
  2. 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 ]
  3. The incidence of adverse events during the study, including all clinically significant laboratory values [ Time Frame: 1 year ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00691145     History of Changes
Other Study ID Numbers: FG-506-06-IT-01
First Posted: June 5, 2008    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014

Keywords provided by Astellas Pharma Inc:
Atopic dermatitis
Tacrolimus ointment

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action