Protopic Ointment in Children Atopic Eczema

Comparative, Multicentre, Randomised, Double-blind Study to Assess the Efficacy of Tacrolimus 0.03% Ointment Versus Fluticasone 0.005% Ointment in Children Aged 2 Years or Over Suffering From Moderate to Severe Atopic Dermatitis.

Children with atopic eczema and a poor response to topical corticosteroid applied either Protopic or Fluticasone ointment twice a day for 3 weeks. They could continue during 3 more weeks once a day if needed.

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Drug: Tacrolimus 0.03%; Drug: Fluticasone 0.005%

Detailed Description

Treatments were to be applied twice daily until clearance, for a maximum of 3 weeks and then, in case of uncleared residual lesions, once daily for up to 3 further weeks. In the event of a flare-up the treatment was to be resumed twice a day until the end of the study.

Statistical methods: An interim analysis was performed on 30% of the planned total sample size, i.e. 140 included patients who had completed the study, to reassess the assumptions made during the planning phase.

• Study Type: Interventional
• Enrollment (Actual): 487
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children with moderate to severe atopic dermatitis (Rajka & Langeland score greater than or equal to 4.5) and who had responded insufficiently to conventional therapies
• Female patients of childbearing age: effective means of contraception throughout the period of the study and for four weeks following the end of the study
• Informed consent
• Therapeutic washout for atopic dermatitis treatments

Exclusion Criteria:

• Genetic epidermal barrier defect, such as Netherton's syndrome, or suffering from erythroderma
• Any female patients who were pregnant or breast-feeding
• Clinical infection due to the VZV virus (varicella, zona), HSV1-2 viruses (herpes), verruca vulgaris or molluscum contagiosum
• Superinfected eczema
• Known hypersensitivity to macrolides or to any other excipient in tacrolimus ointment
• Known hypersensitivity to one of the agents contained in the fluticasone 0.005% ointment preparation
• Ulcerated lesions, of whatever type
• Moderate to severe acne or rosacea
• Patients participating at the same time in another clinical study or who have participated in another clinical study within 28 days of the start of this study
• substance abuse (including that of drugs and alcohol) or mental disorder/psychological state which, in the investigator's opinion, might interfere with the patient's follow-up
• Known serologically proven HIV positivity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: B	Drug: Fluticasone 0.005%; ointment; Other Names: Flixovate® 0.005%
Experimental: A	Drug: Tacrolimus 0.03%; ointment; Other Names: Protopic® 0.03%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients presenting at the week 3 visit (day 21) with an improvement of at least 60% in their modified Eczema Area and Severity Index (mEASI) in comparison to day 1	3 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
mEASI and EASI scores at each visit and percentage change with respect to day 1	1 week and 3 weeks
Global assessment of clinical response by the physician at each visit after day 1	1 week and 3 weeks
Global assessment of clinical response by the patient/parents at each visit after day 1	1 week and 3 weeks
All clinical signs, including sleep quality, severity of pruritus and body surface area affected at each visit	1 week and 3 weeks
Compliance with the treatment assessed from the patient's diary	1 week and 3 weeks
Patient's quality of life assessed at day 1 and day 21	3 weeks
Incidence of adverse events during the study	6 weeks

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Publications and helpful links

Helpful Links

• Link to Results on JAPIC - enter 140567 in the JapicCTI-RNo. field

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): August 1, 2005
• Study Completion (Actual): August 1, 2005

Study Registration Dates

• First Submitted: June 2, 2008
• First Submitted That Met QC Criteria: June 3, 2008
• First Posted (Estimate): June 4, 2008

Study Record Updates

• Last Update Posted (Estimate): September 1, 2014
• Last Update Submitted That Met QC Criteria: August 28, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Child; Tacrolimus; Corticosteroid; Fluticasone propionate; Dermatitis, Atopic; Dermatologic Agents; Calcineurin; Topical Drug Administration
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Atopic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Calcineurin Inhibitors; Fluticasone; Tacrolimus
• Other Study ID Numbers: FG-506-06-FR-05; EUDRACT #:2004-002478-47