Clinical trial NCT00689832: Protopic Ointment in Children Atopic Eczema
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dermatitis, Atopic
Keywords: Dermatitis, Atopic
Dermatologic Agents
Topical Drug Administration
Tacrolimus
Calcineurin
Corticosteroid
Fluticasone propionate
Child
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-06-04
Enrollment: 487
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: 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
timeFrame: 3 weeks
Secondary outcomes:
measure: mEASI and EASI scores at each visit and percentage change with respect to day 1
timeFrame: 1 week and 3 weeks
measure: Global assessment of clinical response by the physician at each visit after day 1
timeFrame: 1 week and 3 weeks
measure: Global assessment of clinical response by the patient/parents at each visit after day 1
timeFrame: 1 week and 3 weeks
measure: All clinical signs, including sleep quality, severity of pruritus and body surface area affected at each visit
timeFrame: 1 week and 3 weeks
measure: Compliance with the treatment assessed from the patient's diary
timeFrame: 1 week and 3 weeks
measure: Patient's quality of life assessed at day 1 and day 21
timeFrame: 3 weeks
measure: Incidence of adverse events during the study
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Paris
country: France
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Central Contact
role: STUDY_DIRECTOR
References: