Trial Outcomes & Findings for A Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis (NCT NCT02635204)

Last Updated: 2018-05-15

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

267 participants

Primary outcome timeframe

Day 15 Visit

Results posted on

2018-05-15

Participant Flow

Participant milestones

Participant milestones
Measure	DFD-06 Cream DFD-06 Cream was applied to subjects with moderate plaque psoriasis twice daily for 14 days.	Vehicle Cream Vehicle Cream was applied to subjects with moderate plaque psoriasis twice daily for 14 days.
Overall Study STARTED	178	89
Overall Study COMPLETED	176	88
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	DFD-06 Cream DFD-06 Cream was applied to subjects with moderate plaque psoriasis twice daily for 14 days.	Vehicle Cream Vehicle Cream was applied to subjects with moderate plaque psoriasis twice daily for 14 days.
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DFD-06 Cream n=178 Participants Participants applied DFD-06 Cream twice daily for 14 days.	Vehicle Cream n=89 Participants Participants received Vehicle Cream and was applied twice daily for 14 days.	Total n=267 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	151 Participants n=93 Participants	75 Participants n=4 Participants	226 Participants n=27 Participants
Age, Categorical >=65 years	27 Participants n=93 Participants	14 Participants n=4 Participants	41 Participants n=27 Participants
Age, Continuous	49.5 years STANDARD_DEVIATION 13.59 • n=93 Participants	50.6 years STANDARD_DEVIATION 15.93 • n=4 Participants	49.8 years STANDARD_DEVIATION 14.40 • n=27 Participants
Sex: Female, Male Female	78 Participants n=93 Participants	45 Participants n=4 Participants	123 Participants n=27 Participants
Sex: Female, Male Male	100 Participants n=93 Participants	44 Participants n=4 Participants	144 Participants n=27 Participants
Region of Enrollment United States	178 Participants n=93 Participants	89 Participants n=4 Participants	267 Participants n=27 Participants

PRIMARY outcome

Timeframe: Day 15 Visit

Population: Intention to treat population defined as all subjects who were randomized and dispensed medication

Outcome measures

Outcome measures
Measure	DFD-06 Cream n=178 Participants Participants received DFD-06 Cream applied topical twice daily for 14 days.	Vehicle Cream n=89 Participants Participants received Vehicle Cream applied topical twice daily for 14 days.
Percentage of Subjects With Treatment Success at Day 15	30.2 percentage of participants	9.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Day 15

Population: Intention to treat

Percent change from baseline in body surface area affected by psoriasis at Day 15. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.

Outcome measures

Outcome measures
Measure	DFD-06 Cream n=178 Participants Participants received DFD-06 Cream applied topical twice daily for 14 days.	Vehicle Cream n=89 Participants Participants received Vehicle Cream applied topical twice daily for 14 days.
Percent Change From Baseline in Body Surface Area at Day 15	-28.9 percentage change in body surface area Standard Deviation 34.00	-6.1 percentage change in body surface area Standard Deviation 32.67

SECONDARY outcome

Timeframe: Baseline and Day 8

Population: Intention to treat population defined as all subjects who were randomized and dispensed medication

Percent of subjects with treatment success at Day 8 Visit defined as an IGA of 0 or 1 with at least a 2 grade reduction from baseline. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.

Outcome measures

Outcome measures
Measure	DFD-06 Cream n=178 Participants Participants received DFD-06 Cream applied topical twice daily for 14 days.	Vehicle Cream n=89 Participants Participants received Vehicle Cream applied topical twice daily for 14 days.
Percent of Subjects With Treatment Success at Day 8 Visit	15.7 percentage of subject	5.6 percentage of subject

Adverse Events

DFD-06 Cream

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Vehicle Cream

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DFD-06 Cream n=178 participants at risk DFD-06 Cream applied to subjects twice daily for 14 days.	Vehicle Cream n=89 participants at risk Vehicle Cream applied to subjects twice daily for 14 days.
Blood and lymphatic system disorders Metastatic Lymphoma	0.56% 1/178 • Number of events 1 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events	0.00% 0/89 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events

Other adverse events

Additional Information

Srinivas Sidgiddi, MD

Dr. Reddy's Lab, Inc

Phone: 609-375-9900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	DFD-06 Cream n=178 participants at risk DFD-06 Cream applied to subjects twice daily for 14 days.	Vehicle Cream n=89 participants at risk Vehicle Cream applied to subjects twice daily for 14 days.
Gastrointestinal disorders abdominal pain	0.56% 1/178 • Number of events 1 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events	0.00% 0/89 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events
Skin and subcutaneous tissue disorders application site discolouration	1.7% 3/178 • Number of events 3 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events	2.2% 2/89 • Number of events 2 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events
Skin and subcutaneous tissue disorders Application Site Fissure	1.1% 2/178 • Number of events 2 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events	3.4% 3/89 • Number of events 3 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events
Skin and subcutaneous tissue disorders Application Site Pain	4.5% 8/178 • Number of events 8 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events	7.9% 7/89 • Number of events 7 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events
Skin and subcutaneous tissue disorders Application Site Pruritus	2.8% 5/178 • Number of events 5 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events	9.0% 8/89 • Number of events 8 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events
Skin and subcutaneous tissue disorders Application site Telangiectasia	1.1% 2/178 • Number of events 2 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events	0.00% 0/89 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.56% 1/178 • Number of events 1 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events	0.00% 0/89 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events
Infections and infestations Infections and Infestations	1.1% 2/178 • Number of events 2 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events	0.00% 0/89 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events
Skin and subcutaneous tissue disorders Application site Folliculitis	0.56% 1/178 • Number of events 1 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events	0.00% 0/89 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events
Infections and infestations Cronic hepatitis C	0.56% 1/178 • Number of events 1 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events	0.00% 0/89 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events
Nervous system disorders Nervous System Disorders	0.56% 1/178 • Number of events 1 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events	1.1% 1/89 • Number of events 1 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events
General disorders Headache	0.56% 1/178 • Number of events 1 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events	0.00% 0/89 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events
Nervous system disorders Hypoaesthesia	0.00% 0/178 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events	1.1% 1/89 • Number of events 1 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events
Injury, poisoning and procedural complications Foot Fracture	0.56% 1/178 • Number of events 1 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events	0.00% 0/89 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events
Blood and lymphatic system disorders Lymphadenopathy	0.56% 1/178 • Number of events 1 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events	0.00% 0/89 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events
Hepatobiliary disorders Cirrhosis Alcoholic	0.56% 1/178 • Number of events 1 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events	0.00% 0/89 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.56% 1/178 • Number of events 1 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events	0.00% 0/89 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Lymphoma	0.56% 1/178 • Number of events 1 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events	0.00% 0/89 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events
Musculoskeletal and connective tissue disorders Joint Swelling	0.00% 0/178 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events	1.1% 1/89 • Number of events 1 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events
Musculoskeletal and connective tissue disorders Pain in extremity	0.56% 1/178 • Number of events 1 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events	0.00% 0/89 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events
Skin and subcutaneous tissue disorders Night Sweats	0.56% 1/178 • Number of events 1 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events	0.00% 0/89 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events
Skin and subcutaneous tissue disorders Pruritus	0.56% 1/178 • Number of events 1 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events	0.00% 0/89 • Baseline to Day 15 Visit Subjects queried at every visit for Adverse Events