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

Dermatitis, Atopic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00523952
• Other study ID #: FG-506-06-CEE-01
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2007
• Last updated: August 28, 2014
• Start date: January 2004
• Est. completion date: September 2005

Study information

• Verified date: August 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsHungary: National Institute of PharmacyCzech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Czech Republic,  Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		12 weeks	No
Secondary	Physician's evaluation of clinical response		12 weeks	No
Secondary	Patient's assessment of global response		12 weeks	No
Secondary	Affected body surface area		12 weeks	No
Secondary	Quality of Life at Baseline/Day 1 and Week 12/End of study		12 weeks	No
Secondary	Changes of mEASI		12 weeks	No
Secondary	Incidence of adverse events during the study, including all clinically significant laboratory values		12 weeks	No

External Links

•   Link to Results on JAPIC - enter 140565 in the JapicCTI-RNo. field