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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.


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


Minimum age: 3 Months. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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