ALTODERM

Aims:

This study is designed to investigate the efficacy of Altoderm compared to vehicle in subjects who have received 4 weeks regular treatment with emollients and still have symptoms. It is believed from the results of previous studies that both Altoderm and vehicle are effective treatments for atopic dermatitis in children.

Study Design:

This will be a multi-centre, double blind, randomised, parallel-group study in patients with atopic dermatitis aged over 2 years but less than 12 years . The study will consist of a pre-screening contact; an initial screening visit and 6 further visits. Subjects meeting the entry criteria will be randomised to either Altoderm or the vehicle control. Test treatments will be administered double-blind for 12 weeks. Patients will be seen after 2 weeks of test treatment, after 4 weeks, after 8 weeks , and after 12 weeks

The use of emollients will be recorded by the parent by daily weighing of containers and recording the number of times used/day on diary cards. The SCORAD score is an established and validated measure of severity of atopic dermatitis and will remain the primary outcome measure.