Protopic Ointment in Children Atopic Eczema

Astellas Pharma Inc487 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

487

Conditions

Dermatitis, Atopic

Interventions

Tacrolimus 0.03%DRUG

ointment

Fluticasone 0.005%DRUG

ointment

Eligibility

Sex: ALLMin age: 2 YearsMax age: 15 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Paris, France

Outcomes

Primary Outcomes

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

Time frame: 3 weeks