Protopic Ointment in Children Atopic Eczema

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Drug: Tacrolimus 0.03%
* Drug: Fluticasone 0.005%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Tacrolimus 0.03%<br>* ointment<br>* Other names: Protopic® 0.03%;|
| Active Comparator: B<br> | Drug: Fluticasone 0.005%<br>* ointment<br>* Other names: Flixovate® 0.005%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dermatitis, Atopic, Dermatologic Agents, Topical Drug Administration, Tacrolimus, Calcineurin, Corticosteroid, Fluticasone propionate, Child