A Study of Protopic (Tacrolimus) Ointment in Children With Atopic Dermatitis

Phase 1

• Conditions: Atopic dermatitis; MedDRA version: 19.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2016-001160-11-Outside-EU/EEA
• Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-30
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 170

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified