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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01137032
Recruitment Status : Completed
First Posted : June 4, 2010
Results First Posted : March 29, 2016
Last Update Posted : May 4, 2016
Sponsor:
Information provided by (Responsible Party):
Fougera Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE June 2, 2010
First Posted Date  ICMJE June 4, 2010
Results First Submitted Date  ICMJE February 26, 2016
Results First Posted Date  ICMJE March 29, 2016
Last Update Posted Date May 4, 2016
Study Start Date  ICMJE June 2004
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 3, 2010)
Post-injection Serum Cortisol Level [ Time Frame: 22 Days ]
The number of subjects with a post-injection serum cortisol level exceeding 18 ug/dL on Day 22.
Change History Complete list of historical versions of study NCT01137032 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2016)
  • 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.
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2010)
Pre-injection Serum Cortisol Levels [ Time Frame: 22 Days ]
The number of subjects with pre-injection serum cortisol levels exceeding 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Psoriasis
  • Atopic Dermatitis
Intervention  ICMJE Drug: Pandel Cream 0.1%
A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
Study Arms  ICMJE Experimental: Pandel Cream 0.1%
Pandel Cream 0.1%
Intervention: Drug: Pandel Cream 0.1%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2010)
19
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2005
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01137032
Other Study ID Numbers  ICMJE ALT 0153-01-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fougera Pharmaceuticals Inc.
Study Sponsor  ICMJE Fougera Pharmaceuticals Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Angela C Kaplan Fougera Pharmaceuticals Inc.
PRS Account Fougera Pharmaceuticals Inc.
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP