Title
Cutivate Lotion HPA Axis Pediatric Study
A Multi-Center, Open-Label Study to Evaluate the Effect of ALTANA Inc's Cutivate (Fluticasone Propionate) Lotion 0.05% on the Hypothalmic Pituitary Adrenal (HPA) Axis in the Treatment of Atopic Dermatitis in a Pediatric Population
Phase
Phase 4Lead Sponsor
FougeraStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Atopic DermatitisIntervention/Treatment
fluticasone ...Study Participants
56A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate, 0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic dermatitis.
Daily applications
Receive between 22 and 29 days of Cutivate lotion treatment
Inclusion Criteria: Subjects are 3-12 months of age Subjects diagnosed with Atopic Dermatitis (AD) and have ≥35% of Body Surface Area Subjects meet protocol specific AD signs and symptom severity score Exclusion Criteria: Subjects with conditions effecting the HPA Axis Subjects with clinically significant systemic disease Subjects who require treatment with systemic or topical retinoids during the study Subjects who have been treated with various chronic therapies identified in the protocol Subjects who have received other investigational drug treatment within 30 days prior to study entry
| Event Type | Organ System | Event Term | Experimental |
|---|
The primary safety parameter was the response to the CST at the end of treatment/final visit. Blood samples were collected prior to injection of cosyntropin and post-injection. Post-CST stimulation cortisol level ≤ 18micrograms/dL was considered as evidence of adrenal suppression.
The frequency distributions of the presence/absence of adverse events associated with signs of atrophy and pigmentation changes were summarized with frequency counts. Hematology and Chemistry Assessments were summarized in shift tables. Signs and symptoms of AD were summarized at each visit.
