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Trial record 7 of 92 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
Enrollment 265
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DFD-06 Cream Vehicle Cream
Hide Arm/Group Description

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

Vehicle Cream: Twice daily topical application for 14 days.

Period Title: Overall Study
Started 176 89
Completed 176 89
Not Completed 0 0
Arm/Group Title DFD-06 Cream Vehicle Cream Total
Hide Arm/Group Description

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

Vehicle Cream: Twice daily topical application for 14 days.

Total of all reporting groups
Overall Number of Baseline Participants 176 89 265
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 176 participants 89 participants 265 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 176 participants 89 participants 265 participants
Female
65
  36.9%
38
  42.7%
103
  38.9%
Male
111
  63.1%
51
  57.3%
162
  61.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 176 participants 89 participants 265 participants
176 89 265
1.Primary Outcome
Title Efficacy (Percentage of Subjects With Treatment Success)
Hide Description

The primary efficacy endpoint is the percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2 grade reduction from Baseline) at the Day 15 visit.

The primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.

Time Frame Day 15 Visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DFD-06 Cream Vehicle Cream
Hide Arm/Group Description:

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

Vehicle Cream: Twice daily topical application for 14 days.

Overall Number of Participants Analyzed 176 89
Measure Type: Number
Unit of Measure: percentage of participants
30.1 9.7
2.Secondary Outcome
Title The Percent Change in Body Surface Area of Psoriasis
Hide Description The percent change from baseline in Body Surface Area at Day 15. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
Time Frame From Baseline to Day 15
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DFD-06 Cream Vehicle Cream
Hide Arm/Group Description:

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

Vehicle Cream: Twice daily topical application for 14 days.

Overall Number of Participants Analyzed 176 89
Mean (Standard Deviation)
Unit of Measure: percentage change in body surface area
-25.1  (36.60) -7.4  (20.28)
3.Secondary Outcome
Title The Percentage of Subjects With Treatment Success at the Day 8 Visit.
Hide Description

The percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2 grade reduction from Baseline) at Day 8.

The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.

Time Frame At Day 8 Visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DFD-06 Cream Vehicle Cream
Hide Arm/Group Description:

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

Vehicle Cream: Twice daily topical application for 14 days.

Overall Number of Participants Analyzed 176 89
Measure Type: Number
Unit of Measure: percentage of participants
14.2 1.6
Time Frame 6 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DFD-06 Cream Vehicle Cream
Hide Arm/Group Description

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

Vehicle Cream: Twice daily topical application for 14 days.

All-Cause Mortality
DFD-06 Cream Vehicle Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   0/176 (0.00%)      0/89 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
DFD-06 Cream Vehicle Cream
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/176 (0.57%)      0/89 (0.00%)    
Infections and infestations     
Cellulitis  1  1/176 (0.57%)  1 0/89 (0.00%)  0
1
Term from vocabulary, Medra
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DFD-06 Cream Vehicle Cream
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/176 (15.34%)      26/89 (29.21%)    
Cardiac disorders     
Heart Valve Incompetence  1  0/176 (0.00%)  0 1/89 (1.12%)  1
Gastrointestinal disorders     
Diarrhoea   1/176 (0.57%)  1 0/89 (0.00%)  0
Toothache   0/176 (0.00%)  0 1/89 (1.12%)  1
Vomiting   2/176 (1.14%)  2 0/89 (0.00%)  0
General disorders     
application site discolouration   4/176 (2.27%)  4 0/89 (0.00%)  0
Application Site Fissure   1/176 (0.57%)  1 5/89 (5.62%)  5
Application Site Pain   12/176 (6.82%)  12 11/89 (12.36%)  11
Application Site Pruritus   5/176 (2.84%)  5 14/89 (15.73%)  14
Application site Rash   0/176 (0.00%)  0 1/89 (1.12%)  1
Chest Pain   0/176 (0.00%)  0 1/89 (1.12%)  1
Immune system disorders     
Seasonal Allergy   1/176 (0.57%)  1 0/89 (0.00%)  0
Infections and infestations     
Cellulitis   0/176 (0.00%)  0 1/89 (1.12%)  1
Gastroenteritis   0/176 (0.00%)  0 1/89 (1.12%)  1
Nasopharyngitis   1/176 (0.57%)  1 1/89 (1.12%)  1
Investigations     
Blood Pressure Increased   1/176 (0.57%)  1 0/89 (0.00%)  0
Nervous system disorders     
Headache   1/176 (0.57%)  1 0/89 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough   1/176 (0.57%)  1 0/89 (0.00%)  0
Oropharyngeal Pain   2/176 (1.14%)  2 0/89 (0.00%)  0
Upper Respiratory Tract Congestion   1/176 (0.57%)  1 0/89 (0.00%)  0
Pulmonary Hypertension   0/176 (0.00%)  0 1/89 (1.12%)  1
Surgical and medical procedures     
Tooth Extraction   1/176 (0.57%)  1 0/89 (0.00%)  0
Vascular disorders     
Hypertension   2/176 (1.14%)  2 0/89 (0.00%)  0
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
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
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