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

Overview

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

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2005

Detailed Description

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

Interventions

  • Drug: tacrolimus ointment
    • tacrolimus, single arm, 0.1 ointment

Arms, Groups and Cohorts

  • Experimental: 1

Clinical Trial Outcome Measures

Primary 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 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Astellas Pharma Inc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Central Contact, Study Director, Astellas Pharma GmbH

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