Trial Outcomes & Findings for Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea (NCT NCT01355471)
NCT ID: NCT01355471
Last Updated: 2021-02-18
Results Overview
Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
293 participants
Primary outcome timeframe
Day 29
Results posted on
2021-02-18
Participant Flow
Participant milestones
| Measure |
CD07805/47 Gel
|
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
148
|
145
|
|
Overall Study
COMPLETED
|
141
|
142
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 3 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
n=148 Participants
|
Placebo
n=145 Participants
|
Total
n=293 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
|
|
Age, Categorical
Between 18 and 65 years
|
136 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
270 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Continuous
|
48.5 years
STANDARD_DEVIATION 11.94 • n=5 Participants
|
46.5 years
STANDARD_DEVIATION 12.10 • n=7 Participants
|
47.5 years
STANDARD_DEVIATION 12.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
140 participants
n=5 Participants
|
138 participants
n=7 Participants
|
278 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: Intent-to-Treat (ITT) population(i.e. Hours 3,6,9,12)
Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).
Outcome measures
| Measure |
CD07805/47 Gel
n=142 Participants
|
Placebo
n=142 Participants
|
|---|---|---|
|
Composite Success
Day 29/ Hour 3
|
36 participants
|
13 participants
|
|
Composite Success
Day 29 / Hour 6
|
36 participants
|
13 participants
|
|
Composite Success
Day 29 / Hour 9
|
25 participants
|
15 participants
|
|
Composite Success
Day 29 / Hour 12
|
30 participants
|
14 participants
|
Adverse Events
CD07805/47 Gel
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CD07805/47 Gel
n=148 participants at risk
|
Placebo
n=145 participants at risk
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.68%
1/148 • Number of events 1
|
0.00%
0/145
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60