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Clinical Trials/EUCTR2016-001160-11-Outside-EU/EEA
EUCTR2016-001160-11-Outside-EU/EEA
Active, not recruiting
Phase 1

An Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Tacrolimus Ointment in the Treatment of Atopic Dermatitis in Pediatric Patients

F. Hoffmann-La Roche AG0 sites170 target enrollmentSeptember 30, 2016

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
F. Hoffmann-La Roche AG
Enrollment
170
Status
Active, not recruiting
Last Updated
9 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 30, 2016
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • \- Children 2\-10 years of age;
  • \- Mild to severe atopic dermatitis.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 170
  • F.1\.2 Adults (18\-64 years) no
  • F.1\.2\.1 Number of subjects for this age range
  • F.1\.3 Elderly (\>\=65 years) no
  • F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • \- Skin disorder other than atopic dermatitis;
  • \- Previous treatment with tacrolimus ointment in a clinical study;
  • \- Known diagnosis or history of cancer, including skin cancer, or human immunodeficiency virus (HIV);
  • \- Clinically infected atopic dermatitis.

Outcomes

Primary Outcomes

Not specified

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