Trial Outcomes & Findings for Eight Week Study of Treatment With DFD-07 for Actinic Keratosis of the Face and Scalp (NCT NCT02654717)

Results Overview

Percent of patients with complete clearance of actinic keratosis (AK) lesions at the end of treatment (8 weeks)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

111 participants

Primary outcome timeframe

8 weeks

Results posted on

2020-03-17

Participant milestones
Measure	DFD-07 Cream DFD-07 cream applied twice daily DFD-07 Cream	Placebo Cream Placebo cream applied twice daily Placebo Cream
Overall Study STARTED	56	55
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal
Measure	DFD-07 Cream DFD-07 cream applied twice daily DFD-07 Cream	Placebo Cream Placebo cream applied twice daily Placebo Cream
Overall Study Adverse Event	2	2
Overall Study Protocol Violation	1	2
Overall Study Withdrawal by Subject	0	1
Overall Study Non-permitted medication	3	0

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	DFD-07 Cream n=56 Participants DFD-07 cream applied twice daily DFD-07 Cream	Placebo Cream n=55 Participants Placebo cream applied twice daily Placebo Cream	Total n=111 Participants Total of all reporting groups
Age, Continuous	72.0 Years STANDARD_DEVIATION 9.27 • n=56 Participants	72.7 Years STANDARD_DEVIATION 6.89 • n=55 Participants	72.4 Years STANDARD_DEVIATION 8.15 • n=111 Participants
Sex: Female, Male Female	3 Participants n=56 Participants	6 Participants n=55 Participants	9 Participants n=111 Participants
Sex: Female, Male Male	53 Participants n=56 Participants	49 Participants n=55 Participants	102 Participants n=111 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Germany	56 participants n=56 Participants	55 participants n=55 Participants	111 participants n=111 Participants
Number of Actinic Keratosis lesions	6.1 Number of lesions STANDARD_DEVIATION 1.2 • n=56 Participants	6.1 Number of lesions STANDARD_DEVIATION 0.99 • n=55 Participants	6.1 Number of lesions STANDARD_DEVIATION 1.09 • n=111 Participants

Timeframe: 8 weeks

Percent of patients with complete clearance of actinic keratosis (AK) lesions at the end of treatment (8 weeks)

Outcome measures
Measure	DFD-07 n=52 Participants Patients treated with DFD07 for 8 weeks	Vehicle n=51 Participants Pts treated with vehicle for 8 weeks
Percent of Patients With Complete Clearance of Lesions	4 Participants	4 Participants

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events
Measure	DFD-07 Cream n=56 participants at risk DFD-07 cream applied twice daily DFD-07 Cream	Placebo Cream n=55 participants at risk Placebo cream applied twice daily Placebo Cream
Cardiac disorders Cardiovascular Event	0.00% 0/56 • Adverse events were collected from Baseline visit until 30 days after the last treatment.	1.8% 1/55 • Number of events 1 • Adverse events were collected from Baseline visit until 30 days after the last treatment.
Musculoskeletal and connective tissue disorders Compression fracture of lumbar vertebral body	1.8% 1/56 • Number of events 1 • Adverse events were collected from Baseline visit until 30 days after the last treatment.	0.00% 0/55 • Adverse events were collected from Baseline visit until 30 days after the last treatment.
Musculoskeletal and connective tissue disorders Knee replacement	0.00% 0/56 • Adverse events were collected from Baseline visit until 30 days after the last treatment.	1.8% 1/55 • Number of events 1 • Adverse events were collected from Baseline visit until 30 days after the last treatment.
Blood and lymphatic system disorders B-cell lymphoma	0.00% 0/56 • Adverse events were collected from Baseline visit until 30 days after the last treatment.	1.8% 1/55 • Number of events 1 • Adverse events were collected from Baseline visit until 30 days after the last treatment.

Other adverse events
Measure	DFD-07 Cream n=56 participants at risk DFD-07 cream applied twice daily DFD-07 Cream	Placebo Cream n=55 participants at risk Placebo cream applied twice daily Placebo Cream
Infections and infestations Nasopharyngitis	5.4% 3/56 • Number of events 3 • Adverse events were collected from Baseline visit until 30 days after the last treatment.	12.7% 7/55 • Number of events 7 • Adverse events were collected from Baseline visit until 30 days after the last treatment.

Dr. Reddy's Laboratories Inc.

Phone: 6093759900