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

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

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2016-001160-11-Outside-EU/EEA
Enrollment
170
Registered
2016-09-30
Start date
Unknown
Completion date
Unknown
Last updated
2016-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic dermatitis MedDRA version: 19.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858

Interventions

Trade Name: Protopic Pharmaceutical Form: Ointment INN or Proposed INN: TACROLIMUS CAS Number: 104987-11-3 Concentration unit: % percent Concentration type: equal Concentration number: 0.03-

Sponsors

F. Hoffmann-La Roche AG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the efficacy of tacrolimus ointment at 0.03% in Brazilian pediatric patients with mild, moderate and severe atopic dermatitis through the Physician’s Global Assessment of Clinical Response;Secondary Objective: - To evaluate the tacrolimus activity in reducing the area and severity of atopic dermatitis through the EASI (eczema area and severity index) score; - To evaluate the tacrolimus action in reducing the percentage of body surface area (% BSA) affected by atopic dermatitis; - To analyze the effect of tacrolimus on the pruritus from the patient with atopic dermatitis; - To evaluate the safety profile of tacrolimus ointment at 0.03% in Brazilian pediatric patients with atopic dermatitis.;Primary end point(s): Clinical response (>90% improvement in areas defined for treatment at baseline) according to Physician’s Global Assessment of Clinical Response Scale;Timepoint(s) of evaluation of this end point: Weeks 0, 1, 3, 6 and 8—

Secondary

MeasureTime frame
Secondary end point(s): - Change in percent of body surface area (BSA) affected compared to Baseline - Change in Eczema Area and Severity Index (EASI) score compared to Baseline - Change in the scale of subject's assessment of pruritus score compared to Baseline - Percentage of participants with adverse events;Timepoint(s) of evaluation of this end point: Weeks 0, 1, 3, 6 and 8—

Countries

Brazil

Contacts

Public ContactRoche Trial Information Hotline

F. Hoffmann-La Roche AG

global.trial_information@roche.com+41616878333

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026