Protopic Ointment in Children Atopic Eczema

Astellas

Status and phase

Completed

Phase 4

Conditions

Dermatitis, Atopic

Treatments

Drug: Fluticasone 0.005%

Drug: Tacrolimus 0.03%

Study type

Interventional

Funder types

Industry

Identifiers

NCT00689832

EUDRACT #:2004-002478-47

FG-506-06-FR-05

Details and patient eligibility

About

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.

Full 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.

Enrollment

487 patients

Sex

All

Ages

2 to 15 years old

Volunteers

No Healthy Volunteers

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