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Completed

NCT Number: NCT00523952

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

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

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Key information

Conditions

Dermatitis, Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Brno, Czechia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus ointment

Drug

tacrolimus, single arm, 0.1 ointment

Other names: Protopic, FK506 Ointment

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 3, 2007
Registry last updated
Sep 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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