Protopic Ointment in Children Atopic Eczema - Full Text View

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00689832

Purpose

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.

Condition	Intervention	Phase
Dermatitis, Atopic	Drug: Tacrolimus 0.03% Drug: Fluticasone 0.005%	Phase IV

MedlinePlus related topics: Eczema

Drug Information available for: Tacrolimus Corticosteroids Fluticasone Fluticasone propionate Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	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.

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

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 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

mEASI and EASI scores at each visit and percentage change with respect to day 1 [ Time Frame: 1 week and 3 weeks ] [ Designated as safety issue: No ]
Global assessment of clinical response by the physician at each visit after day 1 [ Time Frame: 1 week and 3 weeks ] [ Designated as safety issue: No ]
Global assessment of clinical response by the patient/parents at each visit after day 1 [ Time Frame: 1 week and 3 weeks ] [ Designated as safety issue: No ]
All clinical signs, including sleep quality, severity of pruritus and body surface area affected at each visit [ Time Frame: 1 week and 3 weeks ] [ Designated as safety issue: No ]
Compliance with the treatment assessed from the patient's diary [ Time Frame: 1 week and 3 weeks ] [ Designated as safety issue: No ]
Patient's quality of life assessed at day 1 and day 21 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Incidence of adverse events during the study [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	487
Study Start Date:	February 2004
Study Completion Date:	August 2005
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Tacrolimus 0.03% ointment
B: Active Comparator	Drug: Fluticasone 0.005% ointment

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.

Eligibility

Ages Eligible for Study:	2 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689832

Locations

France

Paris, France, 75015

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Central Contact

Astellas Pharma Europe BV

More Information

Link to results on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

Responsible Party:	Astellas Pharma Europe BV ( Disclosure Office Europe )
Study ID Numbers:	FG-506-06-FR-05, EUDRACT #:2004-002478-47
Study First Received:	June 2, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00689832
Health Authority:	France: Afssaps - French Health Products Safety Agency; Belgium: Federal Agency for Medicinal Products and Health Products; Finland: National Agency for Medicines; Morocco: Ministry of Public Health; Tunisia: Office of Pharmacies and Medicines

Keywords provided by Astellas Pharma Inc:

Dermatitis, Atopic
Dermatologic Agents
Topical Drug Administration
Tacrolimus

Calcineurin
Corticosteroid
Fluticasone propionate
Child

Study placed in the following topic categories:

Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
Hypersensitivity, Immediate
Fluticasone

Skin Diseases, Eczematous
Tacrolimus
Eczema
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Anti-Allergic Agents

Immunosuppressive Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 16, 2009