Trial Outcomes & Findings for Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea (NCT NCT01174030)
NCT ID: NCT01174030
Last Updated: 2021-02-26
Results Overview
Composite success defined as 2-grade improvement on Clinician Erythema Assessment (CEA)and Patient Self Assessment-5 (PSA-5). Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.
COMPLETED
PHASE2
269 participants
Day 29
2021-02-26
Participant Flow
Participant milestones
| Measure |
CD07805/47 Gel 0.5% QD
CD07805/47 Gel 0.5% Once Daily
|
CD07805/47 Gel 0.18% QD
CD07805/47 Gel 0.18% Once Daily
|
CD07805/47 Gel 0.18% BID
CD07805/47 Gel 0.18% Twice Daily
|
Vehicle Gel QD
Vehicle Gel Once Daily
|
Vehicle Gel BID
Vehicle Gel Twice Daily
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
53
|
54
|
54
|
55
|
53
|
|
Overall Study
COMPLETED
|
51
|
52
|
52
|
53
|
52
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea
Baseline characteristics by cohort
| Measure |
CD07805/47 Gel 0.5% QD
n=53 Participants
|
CD07805/47 Gel 0.18% QD
n=54 Participants
|
CD07805/47 Gel 0.18% BID
n=54 Participants
|
Vehicle Gel QD
n=55 Participants
|
Vehicle Gel BID
n=53 Participants
|
Total
n=269 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 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
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
257 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Age, Continuous
|
44.9 years
STANDARD_DEVIATION 11.50 • n=5 Participants
|
46.9 years
STANDARD_DEVIATION 12.72 • n=7 Participants
|
43.2 years
STANDARD_DEVIATION 12.28 • n=5 Participants
|
43.4 years
STANDARD_DEVIATION 12.73 • n=4 Participants
|
43.0 years
STANDARD_DEVIATION 12.33 • n=21 Participants
|
44.3 years
STANDARD_DEVIATION 12.32 • n=8 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
217 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
52 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
54 participants
n=7 Participants
|
54 participants
n=5 Participants
|
55 participants
n=4 Participants
|
53 participants
n=21 Participants
|
269 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: Intent-to Treat (ITT) population, LOCF when the data are missing at all four timepoints (i.e. Hours 3, 6, 9, 12) LOCF method will be applied from previous visit.
Composite success defined as 2-grade improvement on Clinician Erythema Assessment (CEA)and Patient Self Assessment-5 (PSA-5). Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.
Outcome measures
| Measure |
CD07805/47 Gel 0.5% QD
n=53 Participants
|
CD07805/47 Gel 0.18% QD
n=54 Participants
|
CD07805/47 Gel 0.18% BID
n=54 Participants
|
Vehicle Gel QD
n=55 Participants
|
Vehicle Gel BID
n=53 Participants
|
|---|---|---|---|---|---|
|
Composite Success
Day 29/Hour 3
|
16 participants
|
10 participants
|
10 participants
|
2 participants
|
4 participants
|
|
Composite Success
Day 29/Hour 6
|
15 participants
|
10 participants
|
9 participants
|
4 participants
|
7 participants
|
|
Composite Success
Day 29/Hour 9
|
17 participants
|
7 participants
|
11 participants
|
2 participants
|
10 participants
|
|
Composite Success
Day 29/Hour 12
|
10 participants
|
5 participants
|
8 participants
|
2 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Day 29Population: ITT population, LOCF when the data are missing at all four timepoints (i.e. Hours 3,6,9,12) LOCF method will be applied from the previous visit.
CEA success defined as 2-grade improvement on CEA. Each concentration/regimen was compared to its respective placebo control as part of the primary analysis. Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema 1. / Amost clear; slight redness 2. / Mild erythema; definite redness 3. / Moderate erythema; marked redness 4. / Severe erythema; fiery redness
Outcome measures
| Measure |
CD07805/47 Gel 0.5% QD
n=53 Participants
|
CD07805/47 Gel 0.18% QD
n=54 Participants
|
CD07805/47 Gel 0.18% BID
n=54 Participants
|
Vehicle Gel QD
n=55 Participants
|
Vehicle Gel BID
n=53 Participants
|
|---|---|---|---|---|---|
|
CEA Success
Day 29/Hour 3
|
27 participants
|
21 participants
|
22 participants
|
12 participants
|
9 participants
|
|
CEA Success
Day 29/Hour 6
|
23 participants
|
21 participants
|
18 participants
|
12 participants
|
12 participants
|
|
CEA Success
Day 29/Hour 9
|
26 participants
|
20 participants
|
23 participants
|
12 participants
|
15 participants
|
|
CEA Success
Day 29/Hour 12
|
20 participants
|
17 participants
|
18 participants
|
12 participants
|
16 participants
|
SECONDARY outcome
Timeframe: day 29Population: ITT population, LOCF when the data are missing at all four timepoints (i.e. Hours 3,6,9,12) LOCF method will be applied from the previous visit.
Each concentration/regimen was compared to its respective placebo control as part of the primary analysis. PSA-5 success defined as 2-grade improvement on PSA-5. Patient Self Assessment - 5 (PSA-5) - Grade/description 0 / No redness 1. / Very mild redness 2. / Mild redness 3. / Moderate redness 4. / Severe redness
Outcome measures
| Measure |
CD07805/47 Gel 0.5% QD
n=53 Participants
|
CD07805/47 Gel 0.18% QD
n=54 Participants
|
CD07805/47 Gel 0.18% BID
n=54 Participants
|
Vehicle Gel QD
n=55 Participants
|
Vehicle Gel BID
n=53 Participants
|
|---|---|---|---|---|---|
|
PSA-5 Success
Day 29/Hour 3
|
25 participants
|
17 participants
|
20 participants
|
7 participants
|
11 participants
|
|
PSA-5 Success
Day 29/Hour 6
|
26 participants
|
13 participants
|
15 participants
|
8 participants
|
11 participants
|
|
PSA-5 Success
Day 29/Hour 9
|
22 participants
|
9 participants
|
19 participants
|
5 participants
|
13 participants
|
|
PSA-5 Success
Day 29/Hour 12
|
20 participants
|
9 participants
|
16 participants
|
5 participants
|
10 participants
|
Adverse Events
CD07805/47 Gel 0.5% QD
CD07805/47 Gel 0.18% QD
CD07805/47 Gel 0.18% BID
Vehicle Gel QD
Vehicle Gel BID
Serious adverse events
| Measure |
CD07805/47 Gel 0.5% QD
n=53 participants at risk
|
CD07805/47 Gel 0.18% QD
n=54 participants at risk
|
CD07805/47 Gel 0.18% BID
n=54 participants at risk
|
Vehicle Gel QD
n=55 participants at risk
|
Vehicle Gel BID
n=53 participants at risk
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastric Reflux
|
0.00%
0/53
|
1.9%
1/54
|
0.00%
0/54
|
0.00%
0/55
|
0.00%
0/53
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/53
|
0.00%
0/54
|
0.00%
0/54
|
1.8%
1/55
|
0.00%
0/53
|
Other adverse events
| Measure |
CD07805/47 Gel 0.5% QD
n=53 participants at risk
|
CD07805/47 Gel 0.18% QD
n=54 participants at risk
|
CD07805/47 Gel 0.18% BID
n=54 participants at risk
|
Vehicle Gel QD
n=55 participants at risk
|
Vehicle Gel BID
n=53 participants at risk
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.7%
3/53
|
5.6%
3/54
|
1.9%
1/54
|
7.3%
4/55
|
0.00%
0/53
|
|
Vascular disorders
Flushing
|
7.5%
4/53
|
1.9%
1/54
|
0.00%
0/54
|
0.00%
0/55
|
0.00%
0/53
|
|
Eye disorders
Intraocular pressure increased
|
13.2%
7/53
|
11.1%
6/54
|
14.8%
8/54
|
16.4%
9/55
|
7.5%
4/53
|
|
Nervous system disorders
Headache
|
7.5%
4/53
|
5.6%
3/54
|
5.6%
3/54
|
1.8%
1/55
|
0.00%
0/53
|
|
Skin and subcutaneous tissue disorders
Skin Burning Sensation
|
5.7%
3/53
|
1.9%
1/54
|
3.7%
2/54
|
1.8%
1/55
|
0.00%
0/53
|
|
Skin and subcutaneous tissue disorders
Skin Warm
|
5.7%
3/53
|
0.00%
0/54
|
1.9%
1/54
|
0.00%
0/55
|
0.00%
0/53
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
2/53
|
0.00%
0/54
|
1.9%
1/54
|
5.5%
3/55
|
1.9%
1/53
|
|
Infections and infestations
Sinusitis
|
0.00%
0/53
|
1.9%
1/54
|
0.00%
0/54
|
3.6%
2/55
|
5.7%
3/53
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60