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

Phase 4

Completed

• Conditions: Atopic Dermatitis; Psoriasis
• Interventions: Drug: Pandel Cream 0.1%

• Registration Number: NCT01137032
• Lead Sponsor: Fougera Pharmaceuticals Inc.

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 psoriasis or atopic dermatitis involving greater than 20% body surface area.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-03
• Study First Posted: 2010-06-04
• Results First Submitted: 2016-02-26
• Results First Submitted QC: 2016-02-26
• Status Verified: 2016-03
• Results First Posted: 2016-03-29
• Last Update Submitted: 2016-03-29
• Last Update Posted: 2016-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pandel Cream 0.1%	Pandel Cream 0.1%	Pandel Cream 0.1%

Primary Outcome Measures

Name	Time	Method
Post-injection Serum Cortisol Level	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 Outcome Measures

Name	Time	Method
and the Number of Subjects With an Increment Between Basal and 30 Minutes Day 22 of at Least 7 ug/dL.	22 days
Pre-injection Serum Cortisol Levels	22 Days	The number of subjects with pre-injection serum cortisol levels less than or equal to 5 ug/dL Day 22.

Trial Locations

Locations (3)

Christopher Huerter, MD; 🇺🇸 Omaha, Nebraska, United States

Oswald Mikell, MD; 🇺🇸 Hilton Head Island, South Carolina, United States

Michael Gold, MD; 🇺🇸 Nashville, Tennessee, United States