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

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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.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Psoriasis
Atopic Dermatitis
Intervention Drug: Pandel Cream 0.1%
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pandel Cream 0.1%
Hide Arm/Group Description 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
Period Title: Overall Study
Started 19
Completed 19
Not Completed 0
Arm/Group Title Pandel Cream 0.1%
Hide Arm/Group Description 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
Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
  84.2%
>=65 years
3
  15.8%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 19 participants
48.3
(23 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
12
  63.2%
Male
7
  36.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants
19
1.Primary Outcome
Title Post-injection Serum Cortisol Level
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
15 subjects represents the subgroup utilized for the analysis of this endpoint.
Arm/Group Title Pandel Cream 0.1%
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
1
2.Secondary Outcome
Title Pre-injection Serum Cortisol Levels
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
15 subjects represents the subgroup utilized for the analysis of this endpoint.
Arm/Group Title Pandel Cream 0.1%
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
0
3.Secondary Outcome
Title and the Number of Subjects With an Increment Between Basal and 30 Minutes Day 22 of at Least 7 ug/dL.
Hide Description [Not Specified]
Time Frame 22 days
Hide Outcome Measure Data
Hide Analysis Population Description
15 subjects represents the subgroup utilized for the analysis of this endpoint.
Arm/Group Title Pandel Cream 0.1%
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pandel Cream 0.1%
Hide Arm/Group Description 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
All-Cause Mortality
Pandel Cream 0.1%
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pandel Cream 0.1%
Affected / at Risk (%)
Total   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pandel Cream 0.1%
Affected / at Risk (%)
Total   7/19 (36.84%) 
General disorders   
PYREXIA  1/19 (5.26%) 
Infections and infestations   
NASOPHARYNGITIS  1/19 (5.26%) 
EAR INFECTION  1/19 (5.26%) 
Investigations   
OCCULT BLOOD  1/19 (5.26%) 
Musculoskeletal and connective tissue disorders   
ARTHRITIS  1/19 (5.26%) 
EXOSTOSIS  1/19 (5.26%) 
ARTHRALGIA  1/19 (5.26%) 
Nervous system disorders   
HEADACHE  1/19 (5.26%) 
DIZZINESS  1/19 (5.26%) 
Psychiatric disorders   
ANXIETY  1/19 (5.26%) 
Respiratory, thoracic and mediastinal disorders   
SINUS CONGESTION  1/19 (5.26%) 
RHINITIS ALLERGIC  1/19 (5.26%) 
Skin and subcutaneous tissue disorders   
RASH  1/19 (5.26%) 
APPLICATION SITE IRRITATION  1/19 (5.26%) 
PRURITUS  1/19 (5.26%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Angela C. Kaplan, Associate Director Clinical Development
Organization: Fougera Pharmaceuticals Inc.
Phone: 631-659-2256
EMail: angela.kaplan@sandoz.com
Layout table for additonal information
Responsible Party: Fougera Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01137032     History of Changes
Other Study ID Numbers: ALT 0153-01-1
First Submitted: June 2, 2010
First Posted: June 4, 2010
Results First Submitted: February 26, 2016
Results First Posted: March 29, 2016
Last Update Posted: May 4, 2016