Protopic Ointment in Adult Atopic Eczema of the Face

Study Overview
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Brief Summary
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Patients with facial 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 or change for the other ointment.

Detailed Description
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Treatments were to be applied twice daily over all lesions on the face (except for the eyelids) 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.

Official Title
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Comparative, Multicentre, Randomized, Double-blind Study to Assess the Efficacy of Tacrolimus 0.1% Ointment Versus Fluticasone 0.005% Ointment in Adult Patients Suffering From Moderate to Severe Atopic Dermatitis and Presenting With So-called 'Red Face' Lesions of the Head and Neck.

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Drug: tacrolimus 0.1%
* Drug: fluticasone 0.005 %


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe AD (Rajka & Langeland score) with lesions to the head and neck defined as 'red face' or 'facial eczema': erythema affecting at least 10% of the surface of the 'face' (head, neck, chest, nape of neck), due to long-term AD At least two flare-ups of 'facial' eczema during the 12 months prior to inclusion and, in the investigator's opinion, conventional treatment had proved ineffective or poorly tolerated 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 Seborrheic dermatitis or contact dermatitis affecting the 'face', or any other facial erythema of non-atopic origin 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 0.1% 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 who participated at the same time in another clinical study or who had participated in another clinical study within 28 days prior to inclusion in the study Any type of substance abuse (including that of drugs and alcohol) or any mental disorder/psychological state which, in the investigator's opinion, might interfere with the patient's follow-up Serologically-proven HIV positivity

Ages Eligible for Study
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Minimum Age: 16 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 0.1%<br>* ointment<br>* Other names: Protopic® 0.1%;|
| 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 local mEASI score (mLEASI) compared to Baseline (day 1). |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients no longer presenting with 'facial' erythema at day 7 and day 21 |  | 1 week and 3 weeks | 
| Assessment of facial pruritus at day 1, day 7 and day 21 |  | 1 week and 3 weeks | 
| Global assessment of clinical response on the 'face' by the physician at day 7 and day 21 |  | 1 week and 3 weeks | 
| Global assessment of clinical response on the 'face' by the patient at day 7 and day 21 |  | 1 week and 3 weeks | 
| Patient's quality of life at day 1 and day 21 |  | 1 week and 3 weeks | 
| mLEASI score values at day 7 and day 21 |  | 1 week and 3 weeks | 
| Physician's assessment of individual signs |  | 1 week and 3 weeks | 
| Quality of sleep at day 1, day 7 and day 21 |  | 1 week and 3 weeks | 
| Affected surface area assessment at day 1, day 7 and day 21 |  | 1 week and 3 weeks | 
| Number of patients using the ointment from the other group to treat facial lesions after day 21 |  | 3 weeks | 
| Incidences of adverse events during the study period |  | 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, Face