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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.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: August 31, 2007
Last updated: August 28, 2014
Last verified: August 2014
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: 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:

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 ]

Secondary Outcome Measures:
  • Physician's evaluation of clinical response [ Time Frame: 12 weeks ]
  • Patient's assessment of global response [ Time Frame: 12 weeks ]
  • Affected body surface area [ Time Frame: 12 weeks ]
  • Quality of Life at Baseline/Day 1 and Week 12/End of study [ Time Frame: 12 weeks ]
  • Changes of mEASI [ Time Frame: 12 weeks ]
  • Incidence of adverse events during the study, including all clinically significant laboratory values [ Time Frame: 12 weeks ]

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%).

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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 identifier: NCT00523952

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
Budapest, Hungary
Debrecen, Hungary
Györ, Hungary
Kecskemet, Hungary
Miskolc, Hungary
Pecs, Hungary
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
Study Director: Central Contact Astellas Pharma GmbH
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00523952     History of Changes
Other Study ID Numbers: FG-506-06-CEE-01
Study First Received: August 31, 2007
Last Updated: August 28, 2014

Keywords provided by Astellas Pharma Inc:
dermatitis, atopic

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 16, 2017