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Completed

NCT Number: NCT01137032

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

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.

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Key information

Conditions

Psoriasis 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 Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

3 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Christopher Huerter, MD, Omaha, Nebraska, United States

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Pandel Cream 0.1%

Drug

A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days

Primary outcomes

  1. Post-injection Serum Cortisol Level

    Time frame: 22 Days

    The number of subjects with a post-injection serum cortisol level less than or equal to 18 ug/dL on Day 22.

Secondary outcomes

  1. Pre-injection Serum Cortisol Levels

    Time frame: 22 Days

    The number of subjects with pre-injection serum cortisol levels less than or equal to 5 ug/dL Day 22.

  2. and the Number of Subjects With an Increment Between Basal and 30 Minutes Day 22 of at Least 7 ug/dL.

    Time frame: 22 days

Sponsors and collaborators

Lead sponsor

Fougera Pharmaceuticals Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jun 4, 2010
Registry last updated
May 4, 2016

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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