Protopic Ointment in Children Atopic Eczema

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.

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.

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.

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