Back to resultsStudy to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population
Primary Purpose
Psoriasis, Atopic Dermatitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pandel Cream 0.1%
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Atopic Dermatitis
Eligibility Criteria
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
Sites / Locations
- Christopher Huerter, MD
- Oswald Mikell, MD
- Michael Gold, MD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pandel Cream 0.1%
Arm Description
Pandel Cream 0.1%
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pre-injection Serum Cortisol Levels
The number of subjects with pre-injection serum cortisol levels less than or equal to 5 ug/dL Day 22.
and the Number of Subjects With an Increment Between Basal and 30 Minutes Day 22 of at Least 7 ug/dL.
Full Information
NCT ID
NCT01137032
First Posted
June 2, 2010
Last Updated
March 29, 2016
Sponsor
Fougera Pharmaceuticals Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01137032
Brief Title
Study to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population
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 Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fougera Pharmaceuticals Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Atopic Dermatitis
Keywords
Psoriasis, Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pandel Cream 0.1%
Arm Type
Experimental
Arm Description
Pandel Cream 0.1%
Intervention Type
Drug
Intervention Name(s)
Pandel Cream 0.1%
Intervention Description
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 Outcome Measure Information:
Title
Post-injection Serum Cortisol Level
Description
The number of subjects with a post-injection serum cortisol level less than or equal to 18 ug/dL on Day 22.
Time Frame
22 Days
Secondary Outcome Measure Information:
Title
Pre-injection Serum Cortisol Levels
Description
The number of subjects with pre-injection serum cortisol levels less than or equal to 5 ug/dL Day 22.
Time Frame
22 Days
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela C Kaplan
Organizational Affiliation
Fougera Pharmaceuticals Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Christopher Huerter, MD
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Oswald Mikell, MD
City
Hilton Head Island
State/Province
South Carolina
ZIP/Postal Code
29926
Country
United States
Facility Name
Michael Gold, MD
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population
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