Study to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population
Information source: Fougera Pharmaceuticals Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis; Atopic Dermatitis
Intervention: Pandel Cream 0.1% (Drug)
Phase: Phase 4
Status: Suspended
Sponsored by: Fougera Pharmaceuticals Inc. Official(s) and/or principal investigator(s): Angela C Kaplan, Study Director, Affiliation: Fougera Pharmaceuticals Inc.
Summary
The purpose of this study is to determine the effect of Pandel® (hydrocortisone probutate
cream) Cream 0. 1% on the Hypothalamic Pituitary Adrenal (HPA) axis in pediatric and adult
subjects with either psoriasis or atopic dermatitis involving greater than 20% body surface
area.
Clinical Details
Official title: An Open -Label Study to Evaluate the Effect of Pandel Cream 0.1% on the Hypothalamic Pituitary Adrenal Axis in the Pediatric and Adult Population
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Post-injection serum cortisol level
Secondary outcome: Pre-injection serum cortisol levels
Eligibility
Minimum age: 3 Months.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Clinical diagnosis of psoriasis or atopic dermatitis involving more than 20% of body
surface area
- Good health with the exception of psoriasis or atopic dermatitis
Exclusion Criteria:
- Any disease affecting the HPA-axis
- Subjects who are pregnant, nursing, or planning a pregnancy within the study
participation period
Locations and Contacts
Christopher Huerter, MD, Omaha, Nebraska 68130, United States
Oswald Mikell, MD, Hilton Head Island, South Carolina 29926, United States
Michael Gold, MD, Nashville, Tennessee 37215, United States
Additional Information
Starting date: June 2004
Last updated: June 25, 2014
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