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
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.