Trial Outcomes & Findings for A Double-Blinded, Randomized Placebo Controlled Pilot Study Comparing the Efficacy and Safety of IncobotulinumtoxinA Versus Saline Injections to the Cheek Region in Patients With Rosacea (NCT NCT01614743)
NCT ID: NCT01614743
Last Updated: 2020-10-08
Results Overview
Live rosacea assessment for each side of the face using the Rosacea Clinical Scorecard for clinical assessment.The Rosacea Clinical Scorecard assesses the primary signs and symptoms of rosacea and is graded as absent (0), mild (1), moderate (2) or severe (3).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks
Results posted on
2020-10-08
Participant Flow
Participant milestones
| Measure |
IncobotulinumtoxinA at Baseline and Week 16
IncobotulinumtoxinA: Experimental injection given at baseline and Week 16
|
Placebo at Baseline, Then incobotulinumtoxinA at 16 Weeks
Bacteriostatic saline: Placebo at baseline, incobotulinumtoxinA at 16 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
|
Overall Study
COMPLETED
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Double-Blinded, Randomized Placebo Controlled Pilot Study Comparing the Efficacy and Safety of IncobotulinumtoxinA Versus Saline Injections to the Cheek Region in Patients With Rosacea
Baseline characteristics by cohort
| Measure |
Group 1 - IncobotulinumtoxinA
n=4 Participants
Experimental injection given at baseline and Week 16
|
Group 2 - Bacteriostatic Saline
n=5 Participants
Placebo at baseline, incobotulinumtoxinA at 16 weeks
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
42 Years
n=93 Participants
|
53 Years
n=4 Participants
|
47 Years
n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeksLive rosacea assessment for each side of the face using the Rosacea Clinical Scorecard for clinical assessment.The Rosacea Clinical Scorecard assesses the primary signs and symptoms of rosacea and is graded as absent (0), mild (1), moderate (2) or severe (3).
Outcome measures
| Measure |
Group 1 - IncobotulinumtoxinA
n=4 Participants
IncobotulinumtoxinA: Experimental injection given at baseline and Week 16
|
Group 2 - Bacteriostatic Saline
n=5 Participants
Bacteriostatic saline: Placebo at baseline, incobotulinumtoxinA at 16 weeks
|
|---|---|---|
|
Percent Change From Baseline in the Rosacea Clinical Score Card
% Diff from baseline, Week 1
|
-0.63 percent change
Standard Deviation 0.49
|
-0.00063 percent change
Standard Deviation 0.23
|
|
Percent Change From Baseline in the Rosacea Clinical Score Card
% Diff from baseline, Week 17
|
-0.83 percent change
Standard Deviation 0.62
|
-0.83 percent change
Standard Deviation 0.64
|
|
Percent Change From Baseline in the Rosacea Clinical Score Card
% Diff from baseline, Week 20
|
-1.04 percent change
Standard Deviation 8.85
|
-0.7 percent change
Standard Deviation 0.53
|
|
Percent Change From Baseline in the Rosacea Clinical Score Card
% Diff from baseline, Week 4
|
-0.65 percent change
Standard Deviation 0.60
|
-0.34 percent change
Standard Deviation 0.21
|
|
Percent Change From Baseline in the Rosacea Clinical Score Card
% Diff from baseline, Week 12
|
-0.80 percent change
Standard Deviation 0.61
|
-0.13 percent change
Standard Deviation 0.13
|
|
Percent Change From Baseline in the Rosacea Clinical Score Card
% Diff from baseline, Week 16
|
-0.67 percent change
Standard Deviation 0.48
|
-0.51 percent change
Standard Deviation 0.34
|
PRIMARY outcome
Timeframe: baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeksRate of adverse events
Outcome measures
| Measure |
Group 1 - IncobotulinumtoxinA
n=4 Participants
IncobotulinumtoxinA: Experimental injection given at baseline and Week 16
|
Group 2 - Bacteriostatic Saline
n=5 Participants
Bacteriostatic saline: Placebo at baseline, incobotulinumtoxinA at 16 weeks
|
|---|---|---|
|
Number of Participants Experiencing Adverse Events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeksSelf-esteem change will be determined by patient self-evaluation using the Heatherton \& Polivy State Self-Esteem (HPSS) Scale. Heatherton \& Polivy State Self-Esteem (HPSS) Scale includes three facets of self-esteem: Appearance, Performance, and Social The scale has a range of 20-100. A score closer to 100 signifies higher self-esteem, while a score closer to 20 signifies lower seld-esteem.
Outcome measures
| Measure |
Group 1 - IncobotulinumtoxinA
n=4 Participants
IncobotulinumtoxinA: Experimental injection given at baseline and Week 16
|
Group 2 - Bacteriostatic Saline
n=5 Participants
Bacteriostatic saline: Placebo at baseline, incobotulinumtoxinA at 16 weeks
|
|---|---|---|
|
Mean Heatherton & Polivy State Self-Esteem (HPSS) Scale Score at Baseline, 1, 4, 12, 16, 17, and 20 Weeks
Week 20
|
51.0 units on a scale
Standard Deviation 12.2
|
34.2 units on a scale
Standard Deviation 8.38
|
|
Mean Heatherton & Polivy State Self-Esteem (HPSS) Scale Score at Baseline, 1, 4, 12, 16, 17, and 20 Weeks
Baseline
|
50.5 units on a scale
Standard Deviation 8.19
|
35.2 units on a scale
Standard Deviation 10.0
|
|
Mean Heatherton & Polivy State Self-Esteem (HPSS) Scale Score at Baseline, 1, 4, 12, 16, 17, and 20 Weeks
Week 1
|
53.0 units on a scale
Standard Deviation 11.8
|
36.0 units on a scale
Standard Deviation 9.35
|
|
Mean Heatherton & Polivy State Self-Esteem (HPSS) Scale Score at Baseline, 1, 4, 12, 16, 17, and 20 Weeks
Week 4
|
53.7 units on a scale
Standard Deviation 15.7
|
34.2 units on a scale
Standard Deviation 10.1
|
|
Mean Heatherton & Polivy State Self-Esteem (HPSS) Scale Score at Baseline, 1, 4, 12, 16, 17, and 20 Weeks
Week 12
|
52.8 units on a scale
Standard Deviation 12.6
|
32.2 units on a scale
Standard Deviation 7.16
|
|
Mean Heatherton & Polivy State Self-Esteem (HPSS) Scale Score at Baseline, 1, 4, 12, 16, 17, and 20 Weeks
Week 16
|
50.3 units on a scale
Standard Deviation 11.0
|
34.6 units on a scale
Standard Deviation 8.88
|
|
Mean Heatherton & Polivy State Self-Esteem (HPSS) Scale Score at Baseline, 1, 4, 12, 16, 17, and 20 Weeks
Week 17
|
52.0 units on a scale
Standard Deviation 10.4
|
33.6 units on a scale
Standard Deviation 5.32
|
SECONDARY outcome
Timeframe: week 1, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks4-point categorical assessment of patient satisfaction with treatment. 1. Highly Satisfied- Optimal cosmetic result 2. Very Satisfied- Obvious improvement in appearance form the initial condition, but not completely optimal for this subject 3. Satisfied- Marked improvement in appearance from initial condition 4. Unsatisfied- The appearance is essentially the same or worse as the original condition.
Outcome measures
| Measure |
Group 1 - IncobotulinumtoxinA
n=4 Participants
IncobotulinumtoxinA: Experimental injection given at baseline and Week 16
|
Group 2 - Bacteriostatic Saline
n=5 Participants
Bacteriostatic saline: Placebo at baseline, incobotulinumtoxinA at 16 weeks
|
|---|---|---|
|
Patient Satisfaction
Week 1
|
3.0 units on a scale
Standard Deviation 0.76
|
3.8 units on a scale
Standard Deviation 0.42
|
|
Patient Satisfaction
Week 20
|
1.7 units on a scale
Standard Deviation 0.52
|
2.2 units on a scale
Standard Deviation 0.79
|
|
Patient Satisfaction
Week 4
|
2.3 units on a scale
Standard Deviation 0.52
|
3.6 units on a scale
Standard Deviation 0.52
|
|
Patient Satisfaction
Week 12
|
3.0 units on a scale
Standard Deviation 0.0
|
3.3 units on a scale
Standard Deviation 0.49
|
|
Patient Satisfaction
Week 16
|
2.7 units on a scale
Standard Deviation 0.52
|
3.2 units on a scale
Standard Deviation 0.79
|
|
Patient Satisfaction
Week 17
|
2.3 units on a scale
Standard Deviation 1.0
|
2.9 units on a scale
Standard Deviation 0.32
|
Adverse Events
Group 1 - IncobotulinumtoxinA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 - Bacteriostatic Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place