None listed
Conditions
Interventions
Group 1 Type of group
Elocon® cream 0.1% will be applied to the lesions once a day for 3 weeks.
Group name:Group 3 Type of group
Elocon® lotion will be applied to the lesions once a day for 3 weeks.
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: • The subjects must belong to the pediatric age group ranging from 6 months to 2 years of age inclusive, they can be of both sexes and any race and have good general health (immunocompetent). • The clinical diagnosis of atopic dermatitis must be established • The disease must compromise 15% or more of the body surface area (BSA) (See Appendix B for BSA approximations). • The global disease must be at least moderate and require treatment with topical corticosteroids. • The subject and the parent / guardian must respect the study restrictions and make all the necessary visits. • The subject´s parent / guardian must sign the informed consent statement. • Subjects should have normal or clinically acceptable morning serum cortisol levels and the normal HPA response as determined by the Cortrosyn® stimulation test performed at Start (before treatment). The results of blood chemistry and blood tests must be within normal limits or be clinically acceptable to the Investigator.
Exclusion criteria
Exclusion criteria: • Subjects with known hypersensitivity to any of the components of the study drug formulation. • Subjects requiring any other medication (topical or systemic) that may affect the HPA axis, the course of the disease during the study period or the assessment of safety in the treatment areas. • Subjects who have taken immunosuppressive medication (including systemic steroids) within the month prior to Day 1 of the Study. • Subjects who have chronic diseases (eg, diabetes, kidney and liver) that may interfere with the interpretation of the study results. • Subjects that have been previously incorporated in this study. • Subjects who have received any drug in the experimental phase within the last 30 days prior to Day 1 of the Study. • Subjects with clinical signs of pre-existing skin atrophy, telangiectasia, or striae at or near the treatment areas. • Subjects who receive any other experimental therapy or who are currently participating in another clinical trial • Subjects with presumed cutaneous infection. • Subjects who have used topical corticosteroids within 7 days prior to incorporation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The function of the HPA axis will be evaluated by monitoring serum cortisol levels before performing the challenge test with Cortrosyn® and 30 minutes after the test, both before treatment (Visit 1) and at Visit 4. Measure:Safety Timepoints:On visits 1, 4 and 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:To evaluate changes in hematology and blood chemistry, routine clinical laboratory tests will be used. Adverse effects will be recorded. Measure:Adverse Efects Timepoints:The blood tests will be carried out on Days 1 (Visit 1) and 22 (Visit 4). The topical and systemic adverse effects will be evaluated in Visits 2, 3 and 4, as well as in the follow-up visits at 14 and 18 days (Visits 5 and 6). | — |
Contacts
Public ContactJorge Timoteo
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed