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

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ClinicalTrials.gov Identifier: NCT00523952
Recruitment Status : Completed
First Posted : September 3, 2007
Last Update Posted : September 1, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 303 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2004
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 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
tacrolimus, single arm, 0.1 ointment
Other Names:
  • Protopic
  • FK506 Ointment




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


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): 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

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00523952     History of Changes
Other Study ID Numbers: FG-506-06-CEE-01
First Posted: September 3, 2007    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014

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

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