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DFD06 Cream vs Clobetasol Propionate Cream, 0.05% Hypothalamic- Pituitary-Adrenal (HPA) Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis (HPA axis)

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ClinicalTrials.gov Identifier: NCT02131324
Recruitment Status : Completed
First Posted : May 6, 2014
Results First Posted : April 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Promius Pharma, LLC

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Psoriasis
Interventions: Drug: DFD06 Cream
Drug: Clobetasol Propionate Cream 0.05%

  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

Washout was needed at Screening Visit if prohibited therapies were in use.

The screening adrenocorticotropic hormone (ACTH) stimulation test was conducted at least 14 days and no more than 28 days prior to the Baseline Visit.


Reporting Groups
  Description
Comp01

applied twice a day for 15 days

Comp01

DFD06 Cream

applied twice a day for 15 days

DFD06 Cream


Participant Flow:   Overall Study
    Comp01   DFD06 Cream
STARTED   24 [1]   26 [2] 
Analyzed   22   24 
COMPLETED   22   23 
NOT COMPLETED   2   3 
Withdrawal by Subject                1                2 
Lost to Follow-up                1                1 
[1] 2 subjects randomized into Comp01 not included in analysis as there was no post-baseline information
[2] 2 subjects randomized into DFD-06 not included in analysis as there was no post-baseline information



  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
DFD06 DFD06 Active
Comp01 Comp01 Comparator
Total Total of all reporting groups

Baseline Measures
   DFD06   Comp01   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   22   46 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      23  95.8%      22 100.0%      45  97.8% 
>=65 years      1   4.2%      0   0.0%      1   2.2% 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.5  (14.5)   50.9  (11.2)   47.0  (13.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      7  29.2%      8  36.4%      15  32.6% 
Male      17  70.8%      14  63.6%      31  67.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      14  58.3%      13  59.1%      27  58.7% 
Not Hispanic or Latino      10  41.7%      9  40.9%      19  41.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      24 100.0%      22 100.0%      46 100.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   24   22   46 
Body Surface Area (BSA) affected by psoriasis [1] 
[Units: Cm^2]
Mean (Standard Deviation)
 26.5  (8.6)   27.0  (8.3)   26.8  (8.4) 
[1] Two subjects dropped out of the study in each arm.


  Outcome Measures

1.  Primary:   The Percentage of Subjects With HPA Axis Suppression.   [ Time Frame: Day 15 ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI 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: NCT02131324     History of Changes
Other Study ID Numbers: DFD06-CD-007
First Submitted: May 2, 2014
First Posted: May 6, 2014
Results First Submitted: May 11, 2017
Results First Posted: April 18, 2018
Last Update Posted: May 18, 2018