Cutivate Lotion HPA Axis Pediatric Study

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fougera Pharmaceuticals Inc.
• Treatments: Fluticasone; Xhance

Criteria

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