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Trial record 7 of 90 for:    cream | "Psoriasis"

A Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT02445807
Recruitment Status : Completed
First Posted : May 15, 2015
Results First Posted : April 13, 2018
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Promius Pharma, LLC

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Stable Plaque Psoriasis
Interventions: Drug: DFD06-Cream
Drug: Vehicle 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
DFD-06 Cream

DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.

DFD06-Cream: Twice daily topical application for 14 days.

Vehicle Cream

Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.

Vehicle Cream: Twice daily topical application for 14 days.


Participant Flow:   Overall Study
    DFD-06 Cream   Vehicle Cream
STARTED   176   89 
COMPLETED   176   89 
NOT COMPLETED   0   0 



  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
DFD-06 Cream

DFD-06 Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.

DFD06-Cream: Twice daily topical application for 14 days.

Vehicle Cream

Vehicle Cream will be applied to subjects with moderate plaque psoriasis twice daily for 14 days.

Vehicle Cream: Twice daily topical application for 14 days.

Total Total of all reporting groups

Baseline Measures
   DFD-06 Cream   Vehicle Cream   Total 
Overall Participants Analyzed 
[Units: Participants]
 176   89   265 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      152  86.4%      70  78.7%      222  83.8% 
>=65 years      24  13.6%      19  21.3%      43  16.2% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      65  36.9%      38  42.7%      103  38.9% 
Male      111  63.1%      51  57.3%      162  61.1% 
Region of Enrollment 
[Units: Participants]
     
United States   176   89   265 


  Outcome Measures

1.  Primary:   Efficacy (Percentage of Subjects With Treatment Success)   [ Time Frame: Day 15 Visit ]

2.  Secondary:   The Percent Change in Body Surface Area of Psoriasis   [ Time Frame: From Baseline to Day 15 ]

3.  Secondary:   The Percentage of Subjects With Treatment Success at the Day 8 Visit.   [ Time Frame: At Day 8 Visit ]


  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 NOT 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:  
Name/Title: Srinivas Sidgiddi, MD
Organization: Dr. Reddy's Lab, Inc
phone: 609-375-9900
e-mail: srinivassidgiddi@drreddys.com



Responsible Party: Promius Pharma, LLC
ClinicalTrials.gov Identifier: NCT02445807     History of Changes
Other Study ID Numbers: DFD06-CD-005
First Submitted: May 13, 2015
First Posted: May 15, 2015
Results First Submitted: January 31, 2018
Results First Posted: April 13, 2018
Last Update Posted: May 15, 2018