Protopic Ointment in Children Atopic Eczema

Dermatitis, Atopic Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689832
• Other study ID #: FG-506-06-FR-05
• Secondary ID: EUDRACT #:2004-0
• Status: Completed
• Phase: Phase 4
• First received: June 2, 2008
• Last updated: August 28, 2014
• Start date: February 2004
• Est. completion date: August 2005

Study information

• Verified date: August 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Belgium: Federal Agency for Medicinal Products and Health ProductsFinland: Finnish Medicines AgencyMorocco: Ministry of Public HealthTunisia: Office of Pharmacies and Medicines
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 487
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 15 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Tacrolimus 0.03%
ointment
• Fluticasone 0.005%
ointment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

France, 

Outcome

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

External Links

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