Atopic dermatitis Skin and Connective Tissue Diseases Atopic dermatitis
Conditions
Interventions
Fluocinonide 0.1% applied, for 14 days, once daily versus twice daily.
Sponsors
Medicis Pharmaceutical Corporation (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ages 3 months to less than 18 years 2. Clinically diagnosed atopic dermatitis greater than or equal to 20% of total body surface area (BSA) 3. Not pregnant 4. Using acceptable birth control
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing 2. Use of concomitant therapies for atopic dermatitis 3. Untreated bacterial, tubercular, fungal or viral lesion of the skin 4. Known sensitivity to any constituents of the study drug 5. Significant disease of the hepatic, renal, endocrine, musculoskeletal or nervous system or any gross physical impairment 6.Irregular sleep schedules 7. History of chronic drug or alcohol abuse 8. Investigational treatment within 30 days prior to study 9. Being treated for or history of melanoma in the past five years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the effect of fluocinonide 0.1% cream to suppress the HPA axis | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Serum cortisol levels before and after stimulation with cosyntropin 2. Skin safety evaluations (signs and symptoms of skin atrophy, telangiectasia, and pigmentation changes) 3. Vital signs and weight 4. Evaluation of any adverse events reported during the study | — |
Countries
United States of America
Outcome results
None listed