Trial Outcomes & Findings for A Study to Assess the Safety and Local Tolerability of DFD-03 (Tazarotene) Lotion, 0.1% Compared to Tazorac® Cream, 0.1% in the Topical Treatment of Acne Vulgaris (NCT NCT03341910)
NCT ID: NCT03341910
Last Updated: 2020-08-17
Results Overview
Frequency count of treatment emergent adverse events will be compared between DFD-03 Lotion and Tazorac Cream groups.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
155 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2020-08-17
Participant Flow
Participant milestones
| Measure |
DFD-03 Lotion, 0.1%
DFD-03 Lotion, 0.1% to be applied twice daily approximately 12 hours apart, for 1 minute and rinsed off
DFD-03 Lotion, 0.1%: DFD-03 Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.
|
Tazorac Cream, 0.1%
Tazorac Cream, 0.1% to be applied once in the evening and left overnight for approximately 12 hours
Tazorac Cream, 0.1%: Tazorac Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.
|
DFD-03 Vehicle Lotion
Vehicle Lotion to be applied twice daily for 1 minute and rinsed off
DFD-03 Vehicle Lotion 0%: Vehicle Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.
|
Tazorac Vehicle Cream
Vehicle Cream to be applied once in the evening and left overnight for approximately 12 hours
Tazorac Vehicle Cream 0%: Vehicle Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
54
|
49
|
26
|
26
|
|
Overall Study
COMPLETED
|
54
|
49
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Safety and Local Tolerability of DFD-03 (Tazarotene) Lotion, 0.1% Compared to Tazorac® Cream, 0.1% in the Topical Treatment of Acne Vulgaris
Baseline characteristics by cohort
| Measure |
DFD-03 Lotion, 0.1%
n=54 Participants
DFD-03 Lotion, 0.1% to be applied twice daily approximately 12 hours apart, for 1 minute and rinsed off
DFD-03 Lotion, 0.1%: DFD-03 Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.
|
Tazorac Cream, 0.1%
n=49 Participants
Tazorac Cream, 0.1% to be applied once in the evening and left overnight for approximately 12 hours
Tazorac Cream, 0.1%: Tazorac Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.
|
DFD-03 Vehicle Lotion
n=26 Participants
Vehicle Lotion to be applied twice daily for 1 minute and rinsed off
DFD-03 Vehicle Lotion 0%: Vehicle Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.
|
Tazorac Vehicle Cream
n=26 Participants
Vehicle Cream to be applied once in the evening and left overnight for approximately 12 hours
Tazorac Vehicle Cream 0%: Vehicle Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
20 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
21.9 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
23.1 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
22.0 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
25.0 years
STANDARD_DEVIATION 10.5 • n=4 Participants
|
22.8 years
STANDARD_DEVIATION 9.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
128 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
49 participants
n=7 Participants
|
26 participants
n=5 Participants
|
26 participants
n=4 Participants
|
155 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Safety Population - All subjects who received study product and provided any post baseline safety information.
Frequency count of treatment emergent adverse events will be compared between DFD-03 Lotion and Tazorac Cream groups.
Outcome measures
| Measure |
DFD-03 Lotion, 0.1%
n=54 Participants
DFD-03 Lotion, 0.1% to be applied twice daily approximately 12 hours apart, for 1 minute and rinsed off
DFD-03 Lotion, 0.1%: DFD-03 Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.
|
Tazorac Cream, 0.1%
n=49 Participants
Tazorac Cream, 0.1% to be applied once in the evening and left overnight for approximately 12 hours
Tazorac Cream, 0.1%: Tazorac Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.
|
DFD-03 Vehicle Lotion
n=26 Participants
Vehicle Lotion to be applied twice daily for 1 minute and rinsed off
DFD-03 Vehicle Lotion 0%: Vehicle Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.
|
Tazorac Vehicle Cream
n=26 Participants
Vehicle Cream to be applied once in the evening and left overnight for approximately 12 hours
Tazorac Vehicle Cream 0%: Vehicle Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.
|
|---|---|---|---|---|
|
Adverse Event Occurences in DFD-03 Lotion Versus Tazorac Cream Groups
|
73 Adverse Events
|
81 Adverse Events
|
14 Adverse Events
|
15 Adverse Events
|
Adverse Events
DFD-03 Lotion, 0.1%
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Tazorac Cream, 0.1%
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Vehicle Lotion
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Vehicle Cream
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DFD-03 Lotion, 0.1%
n=54 participants at risk
DFD-03 Lotion, 0.1% was applied twice daily approximately 12 hours apart, for 1 minute and rinsed off
DFD-03 Lotion, 0.1%: DFD-03 Lotion was applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.
|
Tazorac Cream, 0.1%
n=49 participants at risk
Tazorac Cream, 0.1% was applied once in the evening and left overnight for approximately 12 hours
Tazorac Cream, 0.1%: Tazorac Cream was applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.
|
Vehicle Lotion
n=26 participants at risk
Vehicle Lotion was applied twice daily for 1 minute and rinsed off
DFD-03 Vehicle Lotion 0%: Vehicle Lotion was applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.
|
Vehicle Cream
n=26 participants at risk
Vehicle Cream was applied once in the evening and left overnight for approximately 12 hours
Tazorac Vehicle Cream 0%: Vehicle Cream was applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.
|
|---|---|---|---|---|
|
General disorders
Application site dryness
|
33.3%
18/54 • Number of events 18 • Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
|
34.7%
17/49 • Number of events 17 • Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
|
11.5%
3/26 • Number of events 3 • Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
|
|
General disorders
Application site exfoliation
|
25.9%
14/54 • Number of events 14 • Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
|
24.5%
12/49 • Number of events 12 • Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
|
11.5%
3/26 • Number of events 3 • Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
|
|
General disorders
Application Site Pain
|
25.9%
14/54 • Number of events 14 • Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
|
26.5%
13/49 • Number of events 13 • Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
|
|
General disorders
Application Site Erythema
|
14.8%
8/54 • Number of events 8 • Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
|
18.4%
9/49 • Number of events 9 • Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
|
11.5%
3/26 • Number of events 3 • Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
|
|
General disorders
Application Site Pruritus
|
11.1%
6/54 • Number of events 6 • Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
|
6.1%
3/49 • Number of events 3 • Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.9%
1/54 • Number of events 1 • Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
|
10.2%
5/49 • Number of events 5 • Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
|
Additional Information
Dr. Srinivas Sidgiddi, Sr. Director, Clinical Development
Dr. Reddy's Laboratories, Inc
Phone: 609-375-9910
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place