Atopic dermatitis is one of the most frequent skin diseases. The disease is often worst
during winter months when the skin is drier. Mild to moderate cases of atopic dermatitis are
often controlled by a moisturizer alone. The use of moisturizers has been shown to have
beneficial effects on atopic dermatitis. It can break the dry skin cycle by hydrating the
upper layer of the skin which may prevent the recurrence of the disease and can reduce the
use of cream or ointment medications such as corticosteroids. Formulation 609580 20 was
developed to keep the moisturizing efficacy of formulation 609209 but to improve its
tolerance and cosmetic acceptability (easier to apply, nicer texture, etc.). The new
formulation contains the same quantity of shea butter and glycerin but in a different
excipient (inactive substance) than the commercial product. In addition, vitamin B3 was added
to see if it could help in reducing itching.
The purpose of this study is to determine the safety and efficacy of two study products in
children with atopic dermatitis. One of the study products (formulation 609580 20) is not
commercially available (outside of clinical trials such as this one). The other study product
(formulation 609209) has been approved in Canada and is currently available commercially
under the trade name Lipikar Baume.
For this study the child will be randomly assigned to one of the following two groups:
- Group 1: 50 children will receive formulation 609209, the commercial formula for 42 days
and will receive formulation 609580 20, the new formula, for 14 days.
- Group 2: 50 children will receive formulation 609580 20, the new formula, for 42 days
and will receive formulation 609209, the commercial formula, for 14 days.