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Trial record 9 of 90 for:    cream | "Psoriasis"

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

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: 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cloderm Cream

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

Cloderm Cream


Participant Flow:   Overall Study
    Cloderm Cream
STARTED   60 
COMPLETED   57 
NOT COMPLETED   3 
Lost to Follow-up                1 
Physician Decision                1 
Withdrawal by Subject                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cloderm Cream

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

Cloderm Cream


Baseline Measures
   Cloderm Cream 
Overall Participants Analyzed 
[Units: Participants]
 60 
Age 
[Units: Years]
Mean (Standard Deviation)
 50  (12.2) 
Gender 
[Units: Participants]
 
Female   21 
Male   39 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   1 
Asian   1 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   3 
White   55 
More than one race   0 
Unknown or Not Reported   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   0 
Not Hispanic or Latino   0 
Unknown or Not Reported   60 
Region of Enrollment 
[Units: Participants]
 
United States   60 


  Outcome Measures

1.  Primary:   Investigator's Global Assessment (IGA)   [ Time Frame: 28 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director Clinical Operations
Organization: Promius Pharma
phone: 609-282-1404
e-mail: jfraser@drreddys.com



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