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

Astellas

Status and phase: Completed; Phase 3

Conditions: Dermatitis, Atopic

Treatments: Drug: tacrolimus ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT00523952

FG-506-06-CEE-01

Details and patient eligibility

About

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 description

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

Enrollment: 303 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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303 participants in 1 patient group

1

Experimental group

Treatment:

Drug: tacrolimus ointment