Status:

COMPLETED

Study to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population

Lead Sponsor:

Fougera Pharmaceuticals Inc.

Conditions:

Psoriasis

Atopic Dermatitis

Eligibility:

All Genders

3+ years

Phase:

PHASE4

Brief 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...

Eligibility Criteria

Inclusion

  • 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

  • Any disease affecting the HPA-axis
  • Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period

Key Trial Info

Start Date :

June 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2005

Estimated Enrollment :

19 Patients enrolled

Trial Details

Trial ID

NCT01137032

Start Date

June 1 2004

End Date

August 1 2005

Last Update

May 4 2016

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Christopher Huerter, MD

Omaha, Nebraska, United States, 68130

2

Oswald Mikell, MD

Hilton Head Island, South Carolina, United States, 29926

3

Michael Gold, MD

Nashville, Tennessee, United States, 37215