Trial Outcomes & Findings for Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea (NCT NCT01659853)
NCT ID: NCT01659853
Last Updated: 2022-08-25
Results Overview
Composite Success, defined as a 2-grade improvement at 6 hours on both the clinician's and subject's erythema assessments at the end of each treatment period
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
70 participants
Primary outcome timeframe
Hour 6 on Day 15
Results posted on
2022-08-25
Participant Flow
Participant milestones
| Measure |
CD07805/47 Gel 0.5% and Vehicle, Then Azelaic Acid Gel 15%
Subjects were randomly assigned to treatment sequence.
Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) will switch to azelaic acid gel in Period 2.
Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in period 2.
Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information.
|
Azelaic Acid Gel 15%, Then CD07805/47 Gel 0.5% and Vehicle
Subjects were randomly assigned to treatment sequence.
Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) will switch to azelaic acid gel in Period 2.
Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in period 2.
Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information.
|
|---|---|---|
|
Treatment Period 1
STARTED
|
35
|
35
|
|
Treatment Period 1
COMPLETED
|
35
|
35
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout , 3 to 7 Days
STARTED
|
35
|
35
|
|
Washout , 3 to 7 Days
COMPLETED
|
33
|
35
|
|
Washout , 3 to 7 Days
NOT COMPLETED
|
2
|
0
|
|
Treatment Period 2
STARTED
|
33
|
35
|
|
Treatment Period 2
COMPLETED
|
33
|
35
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
CD07805/47 Gel 0.5% and Vehicle, Then Azelaic Acid Gel 15%
Subjects were randomly assigned to treatment sequence.
Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) will switch to azelaic acid gel in Period 2.
Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in period 2.
Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information.
|
Azelaic Acid Gel 15%, Then CD07805/47 Gel 0.5% and Vehicle
Subjects were randomly assigned to treatment sequence.
Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) will switch to azelaic acid gel in Period 2.
Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in period 2.
Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information.
|
|---|---|---|
|
Washout , 3 to 7 Days
Adverse Event
|
1
|
0
|
|
Washout , 3 to 7 Days
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea
Baseline characteristics by cohort
| Measure |
Overall Study
n=70 Participants
Participants were randomly assigned to treatment sequence.
Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2.
Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2.
Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
62 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=5 Participants
|
|
Fitzpatrick skin type
I
|
6 participants
n=5 Participants
|
|
Fitzpatrick skin type
II
|
35 participants
n=5 Participants
|
|
Fitzpatrick skin type
III
|
24 participants
n=5 Participants
|
|
Fitzpatrick skin type
IV
|
4 participants
n=5 Participants
|
|
Fitzpatrick skin type
V
|
1 participants
n=5 Participants
|
|
Fitzpatrick skin type
VI
|
0 participants
n=5 Participants
|
|
Skin type
Dry
|
14 participants
n=5 Participants
|
|
Skin type
Normal
|
33 participants
n=5 Participants
|
|
Skin type
Oily
|
6 participants
n=5 Participants
|
|
Skin type
Combination
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Hour 6 on Day 15Population: A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed.
Composite Success, defined as a 2-grade improvement at 6 hours on both the clinician's and subject's erythema assessments at the end of each treatment period
Outcome measures
| Measure |
CD07805/47 Gel 0.5% and Vehicle
n=35 Participants
Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.
A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed.
|
Azelaic Acid Gel 15%
n=35 Participants
Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.
A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed.
|
|---|---|---|
|
Composite Success
|
14.3 percentage of subjects
|
5.7 percentage of subjects
|
SECONDARY outcome
Timeframe: 30 minutes after baseline treatment application on Day 15Population: A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed. All 70 enrolled subjects were analyzed for efficacy.
Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application
Outcome measures
| Measure |
CD07805/47 Gel 0.5% and Vehicle
n=35 Participants
Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.
A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed.
|
Azelaic Acid Gel 15%
n=35 Participants
Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.
A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed.
|
|---|---|---|
|
Onset of Action
|
31.4 percentage of subjects
|
29.4 percentage of subjects
|
Adverse Events
CD07805/47 Gel 0.5 and Vehicle
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Azelaic Acid 15%
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CD07805/47 Gel 0.5 and Vehicle
n=70 participants at risk
Participants were randomly assigned to treatment sequence.
Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2.
Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2.
Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information.
|
Azelaic Acid 15%
n=68 participants at risk
Participants were randomly assigned to treatment sequence.
Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2.
Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2.
Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information.
|
|---|---|---|
|
General disorders
Medication residue
|
0.00%
0/70 • 15 days
Two subjects in the CD07805/47 group in period 1 did not enter period 2 (1 AE and 1 protocol violation). Therefore, 70 subjects received CD07805/47 and 68 received azelaic acid.
|
13.2%
9/68 • Number of events 9 • 15 days
Two subjects in the CD07805/47 group in period 1 did not enter period 2 (1 AE and 1 protocol violation). Therefore, 70 subjects received CD07805/47 and 68 received azelaic acid.
|
|
Infections and infestations
Upper respiratory infection
|
2.9%
2/70 • Number of events 2 • 15 days
Two subjects in the CD07805/47 group in period 1 did not enter period 2 (1 AE and 1 protocol violation). Therefore, 70 subjects received CD07805/47 and 68 received azelaic acid.
|
2.9%
2/68 • Number of events 2 • 15 days
Two subjects in the CD07805/47 group in period 1 did not enter period 2 (1 AE and 1 protocol violation). Therefore, 70 subjects received CD07805/47 and 68 received azelaic acid.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
21.4%
15/70 • Number of events 20 • 15 days
Two subjects in the CD07805/47 group in period 1 did not enter period 2 (1 AE and 1 protocol violation). Therefore, 70 subjects received CD07805/47 and 68 received azelaic acid.
|
2.9%
2/68 • Number of events 2 • 15 days
Two subjects in the CD07805/47 group in period 1 did not enter period 2 (1 AE and 1 protocol violation). Therefore, 70 subjects received CD07805/47 and 68 received azelaic acid.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/70 • 15 days
Two subjects in the CD07805/47 group in period 1 did not enter period 2 (1 AE and 1 protocol violation). Therefore, 70 subjects received CD07805/47 and 68 received azelaic acid.
|
8.8%
6/68 • Number of events 6 • 15 days
Two subjects in the CD07805/47 group in period 1 did not enter period 2 (1 AE and 1 protocol violation). Therefore, 70 subjects received CD07805/47 and 68 received azelaic acid.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.4%
1/70 • Number of events 1 • 15 days
Two subjects in the CD07805/47 group in period 1 did not enter period 2 (1 AE and 1 protocol violation). Therefore, 70 subjects received CD07805/47 and 68 received azelaic acid.
|
14.7%
10/68 • Number of events 11 • 15 days
Two subjects in the CD07805/47 group in period 1 did not enter period 2 (1 AE and 1 protocol violation). Therefore, 70 subjects received CD07805/47 and 68 received azelaic acid.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
1.4%
1/70 • Number of events 1 • 15 days
Two subjects in the CD07805/47 group in period 1 did not enter period 2 (1 AE and 1 protocol violation). Therefore, 70 subjects received CD07805/47 and 68 received azelaic acid.
|
8.8%
6/68 • Number of events 6 • 15 days
Two subjects in the CD07805/47 group in period 1 did not enter period 2 (1 AE and 1 protocol violation). Therefore, 70 subjects received CD07805/47 and 68 received azelaic acid.
|
|
Skin and subcutaneous tissue disorders
Skin discomfort
|
0.00%
0/70 • 15 days
Two subjects in the CD07805/47 group in period 1 did not enter period 2 (1 AE and 1 protocol violation). Therefore, 70 subjects received CD07805/47 and 68 received azelaic acid.
|
2.9%
2/68 • Number of events 2 • 15 days
Two subjects in the CD07805/47 group in period 1 did not enter period 2 (1 AE and 1 protocol violation). Therefore, 70 subjects received CD07805/47 and 68 received azelaic acid.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60