Trial Outcomes & Findings for A Study to Assess the Efficacy, Safety and Tolerability of DFD-04 (NCT NCT02828241)

Last Updated: 2019-01-23

Results Overview

Mean change from Baseline in the inflammatory lesion count at the End of Treatment. A lower score at the end of the study compared to Baseline is considered a better outcome.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

61 participants

Primary outcome timeframe

At the end of study (12 weeks)

Results posted on

2019-01-23

Participant Flow

Subjects were randomized to either DFD-04 Ointment or Placebo Ointment in a ratio of 2:1

Participant milestones

Participant milestones
Measure	DFD-04 Ointment DFD-04 (Itraconazole) Ointment applied over the affected areas on the face twice daily with approximately 12 hours between applications.	Placebo Ointment Placebo Ointment applied over the affected areas on the face twice daily with approximately 12 hours between applications.
Overall Study STARTED	38	23
Overall Study COMPLETED	30	21
Overall Study NOT COMPLETED	8	2

Reasons for withdrawal

Reasons for withdrawal
Measure	DFD-04 Ointment DFD-04 (Itraconazole) Ointment applied over the affected areas on the face twice daily with approximately 12 hours between applications.	Placebo Ointment Placebo Ointment applied over the affected areas on the face twice daily with approximately 12 hours between applications.
Overall Study Adverse Event	7	2
Overall Study Protocol Violation	1	0

Baseline Characteristics

A Study to Assess the Efficacy, Safety and Tolerability of DFD-04

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DFD-04 Ointment n=38 Participants DFD-04 (Itraconazole) Ointment	Placebo Ointment n=23 Participants Placebo Ointment t	Total n=61 Participants Total of all reporting groups
Age, Continuous	50.4 years STANDARD_DEVIATION 8.1 • n=5 Participants	44.3 years STANDARD_DEVIATION 10.2 • n=7 Participants	48.1 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	18 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants	23 Participants n=7 Participants	61 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Germany	38 participants n=5 Participants	23 participants n=7 Participants	61 participants n=5 Participants

PRIMARY outcome

Timeframe: At the end of study (12 weeks)

Population: Intent to Treat (ITT)

Mean change from Baseline in the inflammatory lesion count at the End of Treatment. A lower score at the end of the study compared to Baseline is considered a better outcome.

Outcome measures

Outcome measures
Measure	DFD-04 Ointment n=38 Participants DFD-04 (Itraconazole) Ointment	Placebo Ointment n=23 Participants Placebo Ointment t
Change in Inflammatory Lesion Counts	-1.4 Number of lesions Standard Deviation 13.8	2.9 Number of lesions Standard Deviation 17.5

PRIMARY outcome

Timeframe: At the end of study (12 weeks)

Population: Intent to Treat (ITT) population

Number of subjects with treatment success based on Investigator's Global Assessment (IGA) score at the End of Treatment, defined as an IGA score of 0 (clear) or 1 (almost clear) with composite grade change from Baseline of at least 2 points.

Outcome measures

Outcome measures
Measure	DFD-04 Ointment n=38 Participants DFD-04 (Itraconazole) Ointment	Placebo Ointment n=23 Participants Placebo Ointment t
Number of Subjects With Investigator's Global Assessment (IGA) Success	3 participants	2 participants

PRIMARY outcome

Timeframe: At end of study (12 weeks)

Population: ITT population

Number of subjects with Treatment Success defined as a score of 0 or 1 and a 2 grade improvement on the CEA scale from Baseline to 12 weeks.

Outcome measures

Outcome measures
Measure	DFD-04 Ointment n=38 Participants DFD-04 (Itraconazole) Ointment	Placebo Ointment n=23 Participants Placebo Ointment t
Number of Subjects With Treatment Success by Clinician's Erythema Assessment (CEA) Scale	2 participants	2 participants

Adverse Events

DFD-04 Ointment

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

Placebo Ointment

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Katherine D'Angelo

Dr. Reddy's Laboratories

Phone: 609-282-1400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	DFD-04 Ointment n=38 participants at risk DFD-04 (Itraconazole) Ointment	Placebo Ointment n=23 participants at risk Placebo Ointment t
Gastrointestinal disorders Any Gastrointestinal Disorder	10.5% 4/38 • Number of events 7 • From start of treatment until the end of study visit at 12 weeks.	13.0% 3/23 • Number of events 6 • From start of treatment until the end of study visit at 12 weeks.
General disorders Any General Disorder and Administrative Site Condition	76.3% 29/38 • Number of events 127 • From start of treatment until the end of study visit at 12 weeks.	56.5% 13/23 • Number of events 36 • From start of treatment until the end of study visit at 12 weeks.
Infections and infestations Any Infections and Infestations	31.6% 12/38 • Number of events 16 • From start of treatment until the end of study visit at 12 weeks.	30.4% 7/23 • Number of events 11 • From start of treatment until the end of study visit at 12 weeks.
Investigations Any Investigations	5.3% 2/38 • Number of events 5 • From start of treatment until the end of study visit at 12 weeks.	4.3% 1/23 • Number of events 1 • From start of treatment until the end of study visit at 12 weeks.
Musculoskeletal and connective tissue disorders Any Musculoskeletal and Connective Tissue Disorders	5.3% 2/38 • Number of events 2 • From start of treatment until the end of study visit at 12 weeks.	0.00% 0/23 • From start of treatment until the end of study visit at 12 weeks.
Nervous system disorders Headache	15.8% 6/38 • Number of events 9 • From start of treatment until the end of study visit at 12 weeks.	8.7% 2/23 • Number of events 2 • From start of treatment until the end of study visit at 12 weeks.
Skin and subcutaneous tissue disorders Any Skin and Subcutaneous Tissue Disorders	18.4% 7/38 • Number of events 13 • From start of treatment until the end of study visit at 12 weeks.	21.7% 5/23 • Number of events 6 • From start of treatment until the end of study visit at 12 weeks.
Gastrointestinal disorders Toothache	5.3% 2/38 • Number of events 4 • From start of treatment until the end of study visit at 12 weeks.	0.00% 0/23 • From start of treatment until the end of study visit at 12 weeks.
General disorders Application Site Dryness	18.4% 7/38 • Number of events 7 • From start of treatment until the end of study visit at 12 weeks.	8.7% 2/23 • Number of events 2 • From start of treatment until the end of study visit at 12 weeks.
General disorders Application Site Erythema	26.3% 10/38 • Number of events 13 • From start of treatment until the end of study visit at 12 weeks.	17.4% 4/23 • Number of events 4 • From start of treatment until the end of study visit at 12 weeks.
General disorders Application Site Exfoliation	13.2% 5/38 • Number of events 5 • From start of treatment until the end of study visit at 12 weeks.	17.4% 4/23 • Number of events 4 • From start of treatment until the end of study visit at 12 weeks.
General disorders Application Site Pain	57.9% 22/38 • Number of events 46 • From start of treatment until the end of study visit at 12 weeks.	30.4% 7/23 • Number of events 13 • From start of treatment until the end of study visit at 12 weeks.
General disorders Application Site Pruritus	55.3% 21/38 • Number of events 42 • From start of treatment until the end of study visit at 12 weeks.	39.1% 9/23 • Number of events 9 • From start of treatment until the end of study visit at 12 weeks.
General disorders Application Site Reaction	15.8% 6/38 • Number of events 6 • From start of treatment until the end of study visit at 12 weeks.	4.3% 1/23 • Number of events 1 • From start of treatment until the end of study visit at 12 weeks.
Infections and infestations Application Site Pustules	5.3% 2/38 • Number of events 2 • From start of treatment until the end of study visit at 12 weeks.	0.00% 0/23 • From start of treatment until the end of study visit at 12 weeks.
Infections and infestations Bronchitis Bacterial	2.6% 1/38 • Number of events 1 • From start of treatment until the end of study visit at 12 weeks.	8.7% 2/23 • Number of events 2 • From start of treatment until the end of study visit at 12 weeks.
Infections and infestations Nasopharyngitis	15.8% 6/38 • Number of events 7 • From start of treatment until the end of study visit at 12 weeks.	21.7% 5/23 • Number of events 6 • From start of treatment until the end of study visit at 12 weeks.
Skin and subcutaneous tissue disorders Erythema	7.9% 3/38 • Number of events 3 • From start of treatment until the end of study visit at 12 weeks.	8.7% 2/23 • Number of events 3 • From start of treatment until the end of study visit at 12 weeks.
Skin and subcutaneous tissue disorders Pruritus	5.3% 2/38 • Number of events 2 • From start of treatment until the end of study visit at 12 weeks.	0.00% 0/23 • From start of treatment until the end of study visit at 12 weeks.
Skin and subcutaneous tissue disorders Rosacea	0.00% 0/38 • From start of treatment until the end of study visit at 12 weeks.	8.7% 2/23 • Number of events 2 • From start of treatment until the end of study visit at 12 weeks.
Skin and subcutaneous tissue disorders Skin Burning Sensation	5.3% 2/38 • Number of events 3 • From start of treatment until the end of study visit at 12 weeks.	0.00% 0/23 • From start of treatment until the end of study visit at 12 weeks.
Skin and subcutaneous tissue disorders Skin Reaction	5.3% 2/38 • Number of events 2 • From start of treatment until the end of study visit at 12 weeks.	0.00% 0/23 • From start of treatment until the end of study visit at 12 weeks.