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Clinical Trial to Assess the Efficacy and Safety of Tacrolimus Ointment Treatment of Atopic Dermatitis in Adult Patients

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00523952
First received: August 31, 2007
Last updated: November 13, 2008
Last verified: March 2008
History of Changes
  Purpose

Objective: Assess efficacy and safety of tacrolimus ointment when used in adults with moderate or severe atopic dermatitis. The ointment was applied on the affected skin twice daily for 3 weeks and then once daily until all lesions were cleared


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 12-Week, Exploratory, Non-Comparative, Multi-Centre Study to Evaluate the Efficacy and Safety of 0.1% Tacrolimus Ointment Administered in Adults With Moderate to Severe Atopic Dermatitis

Resource links provided by NLM:

Drug Information available for: Tacrolimus
U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Rate of patients with at least 50% (i.e. at least moderate) improvement according to the Physician's global evaluation of clinical response between Baseline and the Week 12/End of Study Visit [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physician's evaluation of clinical response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Patient's assessment of global response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Affected body surface area [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Quality of Life at Baseline/Day 1 and Week 12/End of study [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Changes of mEASI [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse events during the study, including all clinically significant laboratory values [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 303
Study Start Date: January 2004
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tacrolimus ointment
tacrolimus, single arm, 0.1 ointment
Other Names:
  • Protopic
  • FK506 Ointment

Detailed Description:

The study was a one arm non-comparative study. The only study medication was Tacrolimus ointment 0.1% (Protopic ® 0.1%).

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, any ethnic group, age ≥16
  • Moderate to severe atopic dermatitis
  • Has given informed consent

Exclusion Criteria:

  • Erythroderma
  • Pregnant or breast-feeding
  • Skin infection on the affected area
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00523952

Locations
Czech Republic
Brno, Czech Republic
Hradec Kralove, Czech Republic
Ostrava, Czech Republic
Plzen, Czech Republic
Prague, Czech Republic
Tabor, Czech Republic
Usti nad Labem, Czech Republic
Hungary
Budapest, Hungary
Debrecen, Hungary
Györ, Hungary
Kecskemet, Hungary
Miskolc, Hungary
Pecs, Hungary
Poland
Bialystok, Poland
Czestochowa, Poland
Gdansk, Poland
Katowice, Poland
Krakow, Poland
Lodz, Poland
Lublin, Poland
Poznan, Poland
Sopot, Poland
Szczecin, Poland
Warsaw, Poland
Wroclaw, Poland
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Central Contact Astellas Pharma GmbH
  More Information

No publications provided

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT00523952     History of Changes
Other Study ID Numbers: FG-506-06-CEE-01
Study First Received: August 31, 2007
Last Updated: November 13, 2008
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Hungary: National Institute of Pharmacy
Czech Republic: State Institute for Drug Control

Keywords provided by Astellas Pharma Inc:
dermatitis, atopic
tacrolimus
adult

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013