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Trial record 9 of 92 for:    cream | "Psoriasis"

Study of the Efficacy of Cloderm® Cream in the Treatment of Moderate Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT01714544
Recruitment Status : Completed
First Posted : October 26, 2012
Results First Posted : July 23, 2014
Last Update Posted : July 23, 2014
Sponsor:
Information provided by (Responsible Party):
Promius Pharma, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Intervention Drug: Cloderm Cream
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cloderm Cream
Hide Arm/Group Description

Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days

Cloderm Cream

Period Title: Overall Study
Started 60
Completed 57
Not Completed 3
Reason Not Completed
Lost to Follow-up             1
Physician Decision             1
Withdrawal by Subject             1
Arm/Group Title Cloderm Cream
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Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days

Cloderm Cream

Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants
50  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
21
  35.0%
Male
39
  65.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
American Indian or Alaska Native
1
   1.7%
Asian
1
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   5.0%
White
55
  91.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
0
   0.0%
Unknown or Not Reported
60
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants
60
1.Primary Outcome
Title Investigator's Global Assessment (IGA)
Hide Description The proportion of subjects who demonstrate an IGA score of clear (0) or almost clear (1).
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population, with LOCF for missing data
Arm/Group Title Cloderm Cream
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Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days

Cloderm Cream

Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
15
(8.1 to 26.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cloderm Cream
Hide Arm/Group Description

Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days

Cloderm Cream

All-Cause Mortality
Cloderm Cream
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cloderm Cream
Affected / at Risk (%)
Total   0/60 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cloderm Cream
Affected / at Risk (%)
Total   0/60 (0.00%) 
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.
No report, abstract, oral presentation, or publication proposed by the Investigator/Institution in regard to Study shall be presented or published without the prior written consent of the Sponsor. Sponsor reserves the right to comment on and delay the proposed report, abstract, oral presentation, or publication and to revise as necessary to protect confidential information or intellectual property.
Results Point of Contact
Name/Title: Director Clinical Operations
Organization: Promius Pharma
Phone: 609-282-1404
Responsible Party: Promius Pharma, LLC
ClinicalTrials.gov Identifier: NCT01714544     History of Changes
Other Study ID Numbers: CDC1201
First Submitted: October 23, 2012
First Posted: October 26, 2012
Results First Submitted: June 25, 2014
Results First Posted: July 23, 2014
Last Update Posted: July 23, 2014