Official Title: “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”

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.

Study Type: Interventional

Study Design: Treatment, Open Label, Single Group Assignment

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: Fluticasone propionate 0.05% lotion
  • Daily applications

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Receive between 22 and 29 days of Cutivate lotion treatment

Primary Measures

• Prior and post treatment serum cortisol values will be compared.
  • Time Frame: Up to 29 days of treatment
    Safety Issue?: Yes

Secondary Measures

• Record adverse events, skin atrophy, pigmentation change, hematological and chemistry assessments, and changes in atopic dermatitis severity
  • Time Frame: Over 5-6 visits following the baseline visit through the end of treatment between Day 22-29
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Months

Maximum Age for this Clinical Trial: 12 Months

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Therapeutics, Inc.

Overall Clinical Trial Officials and Contacts

Alan Fleischer Jr., M.D. Principal Investigator Wake Forest University  

Information obtained from ClinicalTrials.gov on January 08, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00546000

Study ID Number: ALT 0434-01-01

ClinicalTrials.gov Identifier: NCT00546000

Health Authority: United States: Food and Drug Administration