Protopic Ointment in Children Atopic Eczema

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Fluticasone; Tacrolimus

Criteria

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