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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%
Enrollment 50

Recruitment Details  
Pre-assignment Details

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.

Arm/Group Title Comp01 DFD06 Cream
Hide Arm/Group Description

applied twice a day for 15 days

Comp01

applied twice a day for 15 days

DFD06 Cream

Period Title: Overall Study
Started 24 [1] 26 [2]
Analyzed 22 24
Completed 22 23
Not Completed 2 3
Reason Not Completed
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
Arm/Group Title DFD06 Comp01 Total
Hide Arm/Group Description DFD06 Active Comp01 Comparator Total of all reporting groups
Overall Number of Baseline Participants 24 22 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 22 participants 46 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 22 participants 46 participants
43.5  (14.5) 50.9  (11.2) 47.0  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 22 participants 46 participants
Female
7
  29.2%
8
  36.4%
15
  32.6%
Male
17
  70.8%
14
  63.6%
31
  67.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 22 participants 46 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 22 participants 46 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 22 participants 46 participants
24 22 46
Body Surface Area (BSA) affected by psoriasis   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm^2
Number Analyzed 24 participants 22 participants 46 participants
26.5  (8.6) 27.0  (8.3) 26.8  (8.4)
[1]
Measure Analysis Population Description: Two subjects dropped out of the study in each arm.
1.Primary Outcome
Title The Percentage of Subjects With HPA Axis Suppression.
Hide Description HPA axis suppression as measured by serum cortisol levels post cosyntropin test (ACTH test)
Time Frame Day 15
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All summaries and analyses were performed on the safety population. All subjects who received at least one confirmed dose of study product and provided any post-baseline safety information were included in the safety population. No imputation was made for missing safety data.
Arm/Group Title Clobetasol Propionate Cream, 0.05% DFD06 Cream
Hide Arm/Group Description:

applied twice a day for 15 days

Clobetasol Propionate Cream, 0.05%

applied twice a day for 15 days

DFD06 Cream

Overall Number of Participants Analyzed 22 24
Measure Type: Number
Unit of Measure: percentage of participants
36.4 12.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clobetasol Propionate Cream, 0.05%, DFD06 Cream
Comments Two-sided hypothesis testing was conducted for all the tests. Resulting p-values less than 0.05 were considered statistically significant unless noted otherwise. No adjustments of p values were made for multiple comparisons.
Type of Statistical Test Equivalence
Comments Two-sided hypothesis testing was conducted for all the tests. Resulting p-values less than 0.05 were considered statistically significant unless noted otherwise. No adjustments of p values were made for multiple comparisons.
Statistical Test of Hypothesis P-Value 0.086
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clobetasol Propionate Cream, 0.05% DFD06 Cream
Hide Arm/Group Description

applied twice a day for 15 days

Clobetasol Propionate Cream 0.05%

applied twice a day for 15 days

DFD06 Cream

All-Cause Mortality
Clobetasol Propionate Cream, 0.05% DFD06 Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)      0/24 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Clobetasol Propionate Cream, 0.05% DFD06 Cream
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      1/24 (4.17%)    
Injury, poisoning and procedural complications     
Injury/Stab Wound  1 [1]  0/22 (0.00%)  0 1/24 (4.17%)  1
1
Term from vocabulary, MedDRA 15.1
Indicates events were collected by systematic assessment
[1]
Stab wound at right lower quadrant of abdomen
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clobetasol Propionate Cream, 0.05% DFD06 Cream
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/22 (50.00%)      5/24 (20.83%)    
Endocrine disorders     
HPA axis suppression  1  8/22 (36.36%)  8 3/24 (12.50%)  3
General disorders     
Application site pain  1  2/22 (9.09%)  2 0/24 (0.00%)  0
Application site pruritus  1  1/22 (4.55%)  1 0/24 (0.00%)  0
Investigations     
Dehydroepiandrosterone sulfate dicreased  1  6/22 (27.27%)  6 2/24 (8.33%)  2
Musculoskeletal and connective tissue disorders     
Back pain  1  1/22 (4.55%)  1 0/24 (0.00%)  0
1
Term from vocabulary, MedDRA 15.1
Indicates events were collected by systematic assessment
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
Name/Title: Srinivas Sidgiddi, MD
Organization: Dr. Reddy's Lab, Inc
Phone: 609-375-9900
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