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

Astellas Pharma Inc303 enrolled

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

303

Conditions

Dermatitis, Atopic

Interventions

tacrolimus ointmentDRUG

tacrolimus, single arm, 0.1 ointment

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (25)

Unnamed facility

Brno, Czechia

Unnamed facility

Hradec Králové, Czechia

Unnamed facility

Ostrava, Czechia

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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