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OpenTrials
Completed

NCT Number: NCT00546000

Cutivate Lotion HPA Axis Pediatric Study

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

3 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre for Health Care Medical Associates, Poway, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluticasone propionate 0.05% lotion

Drug

Daily applications

Primary outcomes

  1. Post Treatment Serum Cortisol Values Will be Compared.

    Time frame: Up to 29 days of treatment

    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.

Secondary outcomes

  1. Record 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

    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.

Sponsors and collaborators

Lead sponsor

Fougera Pharmaceuticals Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 18, 2007
Registry last updated
Jul 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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