Trial Outcomes & Findings for Effect of CD07805/47 Gel in Rosacea Flushing (NCT NCT02300129)
NCT ID: NCT02300129
Last Updated: 2016-10-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Day 22 and Day 36/Early termination
Results posted on
2016-10-20
Participant Flow
Participant milestones
| Measure |
CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo
Period 1:
Application of 1g of CD07805/47 0.5% Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.
Application of 500mg of Placebo Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).
Period 2 (cross-over design):
Application of 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks then 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks.
|
Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo
Period 1:
Application of 1g of Placebo Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.
Application of 500mg of CD07805/47 0.5% Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).
Period 2 (cross-over design):
Application of 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks then 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks.
|
CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47
Period 1:
Application of 1g of CD07805/47 0.5% Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.
Application of 500mg of Placebo Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).
Period 2 (cross-over design):
Application of 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks then 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks.
|
Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47
Period 1:
Application of 1g of Placebo Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.
Application of 500mg of CD07805/47 0.5% Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).
Period 2 (cross-over design):
Application of 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks then 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks.
|
|---|---|---|---|---|
|
Period 1 Session 1 (Day 1)
STARTED
|
11
|
5
|
7
|
11
|
|
Period 1 Session 1 (Day 1)
COMPLETED
|
11
|
5
|
7
|
11
|
|
Period 1 Session 1 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 1 Session 2 (Day 3)
STARTED
|
11
|
5
|
7
|
11
|
|
Period 1 Session 2 (Day 3)
COMPLETED
|
11
|
4
|
7
|
11
|
|
Period 1 Session 2 (Day 3)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Period 1 Session 3 (Day 5)
STARTED
|
11
|
4
|
7
|
11
|
|
Period 1 Session 3 (Day 5)
COMPLETED
|
11
|
4
|
7
|
11
|
|
Period 1 Session 3 (Day 5)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2 Treatment 1 (2 Weeks)
STARTED
|
11
|
4
|
7
|
11
|
|
Period 2 Treatment 1 (2 Weeks)
COMPLETED
|
10
|
4
|
7
|
10
|
|
Period 2 Treatment 1 (2 Weeks)
NOT COMPLETED
|
1
|
0
|
0
|
1
|
|
Period 2 Treatment 2 (2 Weeks)
STARTED
|
10
|
4
|
7
|
10
|
|
Period 2 Treatment 2 (2 Weeks)
COMPLETED
|
10
|
4
|
7
|
10
|
|
Period 2 Treatment 2 (2 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo
Period 1:
Application of 1g of CD07805/47 0.5% Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.
Application of 500mg of Placebo Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).
Period 2 (cross-over design):
Application of 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks then 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks.
|
Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo
Period 1:
Application of 1g of Placebo Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.
Application of 500mg of CD07805/47 0.5% Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).
Period 2 (cross-over design):
Application of 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks then 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks.
|
CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47
Period 1:
Application of 1g of CD07805/47 0.5% Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.
Application of 500mg of Placebo Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).
Period 2 (cross-over design):
Application of 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks then 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks.
|
Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47
Period 1:
Application of 1g of Placebo Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.
Application of 500mg of CD07805/47 0.5% Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).
Period 2 (cross-over design):
Application of 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks then 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks.
|
|---|---|---|---|---|
|
Period 1 Session 2 (Day 3)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Period 2 Treatment 1 (2 Weeks)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Period 2 Treatment 1 (2 Weeks)
Adverse Event
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Effect of CD07805/47 Gel in Rosacea Flushing
Baseline characteristics by cohort
| Measure |
All Study Participants (Intent To Treat Population)
n=33 Participants
One subject was excluded from Intent to Treat (ITT) population because he didn't perform any efficacy assessment during the study so N=33 instead of 34 subjects
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
|
Age, Continuous
|
50.2 years
STANDARD_DEVIATION 10.4 • n=93 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
Germany
|
33 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Day 22 and Day 36/Early terminationPopulation: Per protocol population of Period 2, N= 31
Outcome measures
| Measure |
Period 2 CD07805/47 0.5% Gel Cross-over
n=31 Participants
CD07805/47 0.5% gel (Brimonidine tartrate)
|
Period 2 Placebo Gel Cross-over
n=31 Participants
CD07805/47 placebo gel
|
|---|---|---|
|
Total Number of Flushes for Each 2-week Period
|
15.3 Flushes count
Standard Deviation 12.1
|
16.3 Flushes count
Standard Deviation 14.0
|
Adverse Events
Period 1 Placebo Gel Cross Over
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Period 1 CD07805/47 0.5% Gel Split Face
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Period 1 Placebo Gel Split Face
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Period 1 CD07805/47 0.5% Gel Cross-over
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Period 2 CD07805/47 0.5% Gel Cross Over
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Period 2 Placebo Gel Cross Over
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Period 1 Placebo Gel Cross Over
n=34 participants at risk
Period 1 Placebo gel cross over (application on full face) Overall safety population, N=34
|
Period 1 CD07805/47 0.5% Gel Split Face
n=33 participants at risk
Period 1 CD07805/47 0.5% gel split face (application on one side of face) Overall safety population, N=33
|
Period 1 Placebo Gel Split Face
n=33 participants at risk
Period 1 Placebo gel split face (application on one side of face) Overall safety population, N=33
|
Period 1 CD07805/47 0.5% Gel Cross-over
n=33 participants at risk
Period 1 CD07805/47 0.5% cross over (application on full face) Overall safety population, N=33
|
Period 2 CD07805/47 0.5% Gel Cross Over
n=32 participants at risk
Period 2 CD07805/47 0.5% gel (application on full face) Overall safety population, N=32
|
Period 2 Placebo Gel Cross Over
n=31 participants at risk
Period 2 Placebo gel cross over (application on full face) Overall safety population, N=31
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema and skin tightness
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/33
|
3.0%
1/33 • Number of events 2
|
0.00%
0/32
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Erythema, papules and pruritus
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/33
|
0.00%
0/33
|
3.1%
1/32 • Number of events 3
|
0.00%
0/31
|
|
Infections and infestations
Oral herpes
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/33
|
0.00%
0/33
|
3.1%
1/32 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/33
|
0.00%
0/33
|
3.1%
1/32 • Number of events 1
|
0.00%
0/31
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/33
|
0.00%
0/33
|
3.1%
1/32 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/33
|
0.00%
0/33
|
3.1%
1/32 • Number of events 1
|
0.00%
0/31
|
|
Nervous system disorders
Headache
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/33
|
0.00%
0/33
|
0.00%
0/32
|
3.2%
1/31 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER