Study to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population
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
1 other identifier
interventional
19
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2004
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 2, 2010
CompletedFirst Posted
Study publicly available on registry
June 4, 2010
CompletedResults Posted
Study results publicly available
March 29, 2016
CompletedMay 4, 2016
March 1, 2016
1.2 years
June 2, 2010
February 26, 2016
March 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-injection Serum Cortisol Level
The number of subjects with a post-injection serum cortisol level less than or equal to 18 ug/dL on Day 22.
22 Days
Secondary Outcomes (2)
Pre-injection Serum Cortisol Levels
22 Days
and the Number of Subjects With an Increment Between Basal and 30 Minutes Day 22 of at Least 7 ug/dL.
22 days
Study Arms (1)
Pandel Cream 0.1%
EXPERIMENTALPandel Cream 0.1%
Interventions
A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Any disease affecting the HPA-axis
- Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Angela C. Kaplan, Associate Director Clinical Development
- Organization
- Fougera Pharmaceuticals Inc.
Study Officials
- STUDY DIRECTOR
Angela C Kaplan
Fougera Pharmaceuticals Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2010
First Posted
June 4, 2010
Study Start
June 1, 2004
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
May 4, 2016
Results First Posted
March 29, 2016
Record last verified: 2016-03