Trial Outcomes & Findings for Itch Relieving Effect of Botox: a Study in Healthy Subjects (NCT NCT02639052)
NCT ID: NCT02639052
Last Updated: 2017-04-27
Results Overview
The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Baseline (Visit 1)
Results posted on
2017-04-27
Participant Flow
Participant milestones
| Measure |
Botox and Saline Vehicle Control
10 units of both Botox and a saline vehicle will be intradermally injected into one forearm or the other on the first study visit. The subject will be blinded to which forearm receives the Botox and which forearm receives the saline vehicle.
Botox: 10 units of Botox will be intradermally injected into one 4x4cm area on the volar forearm on 1st study visit.
Saline: 10 units of the Saline vehicle will be intradermally injected into one 4x4cm area on the contralateral volar forearm on the 1st study visit.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
Visit 1 (Baseline)
|
35
|
|
Overall Study
Visit 2 (1-week Follow-up)
|
35
|
|
Overall Study
Visit 3 (1-month Follow-up)
|
35
|
|
Overall Study
Visit 4 (3-month Follow-up)
|
34
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Botox and Saline Vehicle Control
10 units of both Botox and a saline vehicle will be intradermally injected into one forearm or the other on the first study visit. The subject will be blinded to which forearm receives the Botox and which forearm receives the saline vehicle.
Botox: 10 units of Botox will be intradermally injected into one 4x4cm area on the volar forearm on 1st study visit.
Saline: 10 units of the Saline vehicle will be intradermally injected into one 4x4cm area on the contralateral volar forearm on the 1st study visit.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Itch Relieving Effect of Botox: a Study in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Botox and Saline Vehicle Control
n=35 Participants
10 units of both Botox and a saline vehicle will be intradermally injected into one forearm or the other on the first study visit. The subject will be blinded to which forearm receives the Botox and which forearm receives the saline vehicle.
Botox: 10 units of Botox will be intradermally injected into one 4x4cm area on the volar forearm on 1st study visit.
Saline: 10 units of the Saline vehicle will be intradermally injected into one 4x4cm area on the contralateral volar forearm on the 1st study visit.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
26.8 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Visit 1)The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.
Outcome measures
| Measure |
Botox
n=35 Participants
10 units of Botox intradermally injected into one forearm
|
Saline
n=35 Participants
Saline vehicle intradermally injected into the other forearm
|
|---|---|---|
|
Itch by VAS Itch Intensity at Baseline (Visit 1)
Baseline (Visit 1), 0 seconds
|
4.5 units on a scale
Standard Deviation 2.8
|
4.3 units on a scale
Standard Deviation 2.8
|
|
Itch by VAS Itch Intensity at Baseline (Visit 1)
Baseline (Visit 1), 30 seconds
|
6.5 units on a scale
Standard Deviation 2.6
|
6.3 units on a scale
Standard Deviation 2.3
|
|
Itch by VAS Itch Intensity at Baseline (Visit 1)
Baseline (Visit 1), 60 seconds
|
6.8 units on a scale
Standard Deviation 2.2
|
6.5 units on a scale
Standard Deviation 2.1
|
|
Itch by VAS Itch Intensity at Baseline (Visit 1)
Baseline (Visit 1), 90 seconds
|
5.9 units on a scale
Standard Deviation 2.1
|
6.3 units on a scale
Standard Deviation 1.5
|
|
Itch by VAS Itch Intensity at Baseline (Visit 1)
Baseline (Visit 1), 120 seconds
|
5.1 units on a scale
Standard Deviation 2.2
|
5.1 units on a scale
Standard Deviation 2.0
|
|
Itch by VAS Itch Intensity at Baseline (Visit 1)
Baseline (Visit 1), 150 seconds
|
4.1 units on a scale
Standard Deviation 2.2
|
3.9 units on a scale
Standard Deviation 2.1
|
|
Itch by VAS Itch Intensity at Baseline (Visit 1)
Baseline (Visit 1), 180 seconds
|
2.8 units on a scale
Standard Deviation 2.0
|
2.8 units on a scale
Standard Deviation 1.8
|
|
Itch by VAS Itch Intensity at Baseline (Visit 1)
Baseline (Visit 1), 210 seconds
|
2.0 units on a scale
Standard Deviation 1.6
|
2.0 units on a scale
Standard Deviation 1.8
|
|
Itch by VAS Itch Intensity at Baseline (Visit 1)
Baseline (Visit 1), 240 seconds
|
1.3 units on a scale
Standard Deviation 1.5
|
1.4 units on a scale
Standard Deviation 1.7
|
|
Itch by VAS Itch Intensity at Baseline (Visit 1)
Baseline (Visit 1), 270 seconds
|
0.9 units on a scale
Standard Deviation 1.3
|
0.9 units on a scale
Standard Deviation 1.6
|
|
Itch by VAS Itch Intensity at Baseline (Visit 1)
Baseline (Visit 1), 300 seconds
|
0.6 units on a scale
Standard Deviation 1.1
|
0.9 units on a scale
Standard Deviation 1.5
|
|
Itch by VAS Itch Intensity at Baseline (Visit 1)
Baseline (Visit 1), All Times
|
3.7 units on a scale
Standard Deviation 3.0
|
3.7 units on a scale
Standard Deviation 2.9
|
PRIMARY outcome
Timeframe: 1 week from BaselineThe primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.
Outcome measures
| Measure |
Botox
n=35 Participants
10 units of Botox intradermally injected into one forearm
|
Saline
n=35 Participants
Saline vehicle intradermally injected into the other forearm
|
|---|---|---|
|
Itch by VAS Itch Intensity at 1 Week (Visit 2)
1 Week (Visit 2), 0 seconds
|
3.3 units on a scale
Standard Deviation 2.4
|
4.0 units on a scale
Standard Deviation 2.9
|
|
Itch by VAS Itch Intensity at 1 Week (Visit 2)
1 Week (Visit 2), 30 seconds
|
5.4 units on a scale
Standard Deviation 2.3
|
6.7 units on a scale
Standard Deviation 2.2
|
|
Itch by VAS Itch Intensity at 1 Week (Visit 2)
1 Week (Visit 2), 60 seconds
|
5.9 units on a scale
Standard Deviation 2.3
|
6.9 units on a scale
Standard Deviation 2.1
|
|
Itch by VAS Itch Intensity at 1 Week (Visit 2)
1 Week (Visit 2), 90 seconds
|
4.9 units on a scale
Standard Deviation 2.3
|
6.1 units on a scale
Standard Deviation 1.7
|
|
Itch by VAS Itch Intensity at 1 Week (Visit 2)
1 Week (Visit 2), 120 seconds
|
3.7 units on a scale
Standard Deviation 2.4
|
4.8 units on a scale
Standard Deviation 2.0
|
|
Itch by VAS Itch Intensity at 1 Week (Visit 2)
1 Week (Visit 2), 150 seconds
|
2.7 units on a scale
Standard Deviation 2.5
|
3.8 units on a scale
Standard Deviation 2.2
|
|
Itch by VAS Itch Intensity at 1 Week (Visit 2)
1 Week (Visit 2), 180 seconds
|
2.0 units on a scale
Standard Deviation 2.3
|
2.7 units on a scale
Standard Deviation 2.1
|
|
Itch by VAS Itch Intensity at 1 Week (Visit 2)
1 Week (Visit 2), 210 seconds
|
1.4 units on a scale
Standard Deviation 1.8
|
1.9 units on a scale
Standard Deviation 1.9
|
|
Itch by VAS Itch Intensity at 1 Week (Visit 2)
1 Week (Visit 2), 240 seconds
|
0.9 units on a scale
Standard Deviation 1.5
|
1.3 units on a scale
Standard Deviation 1.6
|
|
Itch by VAS Itch Intensity at 1 Week (Visit 2)
1 Week (Visit 2), 270 seconds
|
0.6 units on a scale
Standard Deviation 1.3
|
0.9 units on a scale
Standard Deviation 1.3
|
|
Itch by VAS Itch Intensity at 1 Week (Visit 2)
1 Week (Visit 2), 300 seconds
|
0.4 units on a scale
Standard Deviation 1.1
|
0.7 units on a scale
Standard Deviation 1.3
|
|
Itch by VAS Itch Intensity at 1 Week (Visit 2)
1 Week (Visit 2), All Times
|
2.8 units on a scale
Standard Deviation 2.8
|
3.6 units on a scale
Standard Deviation 2.9
|
PRIMARY outcome
Timeframe: 1 Month from BaselineThe primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.
Outcome measures
| Measure |
Botox
n=35 Participants
10 units of Botox intradermally injected into one forearm
|
Saline
n=35 Participants
Saline vehicle intradermally injected into the other forearm
|
|---|---|---|
|
Itch by VAS Itch Intensity at 1 Month (Visit 3)
1 Month (Visit 3), All Times
|
2.5 units on a scale
Standard Deviation 2.5
|
3.2 units on a scale
Standard Deviation 2.9
|
|
Itch by VAS Itch Intensity at 1 Month (Visit 3)
1 Month (Visit 3), 0 seconds
|
3.2 units on a scale
Standard Deviation 2.6
|
3.8 units on a scale
Standard Deviation 2.8
|
|
Itch by VAS Itch Intensity at 1 Month (Visit 3)
1 Month (Visit 3), 30 seconds
|
5.0 units on a scale
Standard Deviation 2.6
|
6.2 units on a scale
Standard Deviation 2.4
|
|
Itch by VAS Itch Intensity at 1 Month (Visit 3)
1 Month (Visit 3), 60 seconds
|
5.1 units on a scale
Standard Deviation 2.3
|
6.2 units on a scale
Standard Deviation 1.8
|
|
Itch by VAS Itch Intensity at 1 Month (Visit 3)
1 Month (Visit 3), 90 seconds
|
4.3 units on a scale
Standard Deviation 2.3
|
5.7 units on a scale
Standard Deviation 2.3
|
|
Itch by VAS Itch Intensity at 1 Month (Visit 3)
1 Month (Visit 3), 120 seconds
|
3.5 units on a scale
Standard Deviation 2.0
|
4.5 units on a scale
Standard Deviation 2.4
|
|
Itch by VAS Itch Intensity at 1 Month (Visit 3)
1 Month (Visit 3), 150 seconds
|
2.3 units on a scale
Standard Deviation 1.8
|
3.3 units on a scale
Standard Deviation 2.2
|
|
Itch by VAS Itch Intensity at 1 Month (Visit 3)
1 Month (Visit 3), 180 seconds
|
1.5 units on a scale
Standard Deviation 1.4
|
2.2 units on a scale
Standard Deviation 2.1
|
|
Itch by VAS Itch Intensity at 1 Month (Visit 3)
1 Month (Visit 3), 210 seconds
|
0.9 units on a scale
Standard Deviation 1.3
|
1.4 units on a scale
Standard Deviation 1.7
|
|
Itch by VAS Itch Intensity at 1 Month (Visit 3)
1 Month (Visit 3), 240 seconds
|
0.7 units on a scale
Standard Deviation 1.0
|
0.9 units on a scale
Standard Deviation 1.3
|
|
Itch by VAS Itch Intensity at 1 Month (Visit 3)
1 Month (Visit 3), 270 seconds
|
0.3 units on a scale
Standard Deviation 0.7
|
0.6 units on a scale
Standard Deviation 1.0
|
|
Itch by VAS Itch Intensity at 1 Month (Visit 3)
1 Month (Visit 3), 300 seconds
|
0.2 units on a scale
Standard Deviation 0.5
|
0.4 units on a scale
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: 3 Months from BaselineThe primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.
Outcome measures
| Measure |
Botox
n=34 Participants
10 units of Botox intradermally injected into one forearm
|
Saline
n=34 Participants
Saline vehicle intradermally injected into the other forearm
|
|---|---|---|
|
Itch by VAS Itch Intensity at 3 Months (Visit 4)
3 Months (Visit 4), 300 seconds
|
0.3 units on a scale
Standard Deviation 0.6
|
0.6 units on a scale
Standard Deviation 1.1
|
|
Itch by VAS Itch Intensity at 3 Months (Visit 4)
3 Months (Visit 4), 0 seconds
|
2.3 units on a scale
Standard Deviation 1.8
|
3.3 units on a scale
Standard Deviation 2.4
|
|
Itch by VAS Itch Intensity at 3 Months (Visit 4)
3 Months (Visit 4), 30 seconds
|
4.5 units on a scale
Standard Deviation 2.5
|
5.4 units on a scale
Standard Deviation 2.5
|
|
Itch by VAS Itch Intensity at 3 Months (Visit 4)
3 Months (Visit 4), 60 seconds
|
4.9 units on a scale
Standard Deviation 2.3
|
5.9 units on a scale
Standard Deviation 2.2
|
|
Itch by VAS Itch Intensity at 3 Months (Visit 4)
3 Months (Visit 4), 90 seconds
|
4.6 units on a scale
Standard Deviation 2.3
|
5.2 units on a scale
Standard Deviation 2.1
|
|
Itch by VAS Itch Intensity at 3 Months (Visit 4)
3 Months (Visit 4), 120 seconds
|
3.8 units on a scale
Standard Deviation 2.0
|
4.7 units on a scale
Standard Deviation 2.1
|
|
Itch by VAS Itch Intensity at 3 Months (Visit 4)
3 Months (Visit 4), 150 seconds
|
3.0 units on a scale
Standard Deviation 2.0
|
3.6 units on a scale
Standard Deviation 2.1
|
|
Itch by VAS Itch Intensity at 3 Months (Visit 4)
3 Months (Visit 4), 180 seconds
|
2.1 units on a scale
Standard Deviation 1.9
|
2.8 units on a scale
Standard Deviation 1.9
|
|
Itch by VAS Itch Intensity at 3 Months (Visit 4)
3 Months (Visit 4), 210 seconds
|
1.5 units on a scale
Standard Deviation 1.7
|
1.9 units on a scale
Standard Deviation 1.9
|
|
Itch by VAS Itch Intensity at 3 Months (Visit 4)
3 Months (Visit 4), 240 seconds
|
1.0 units on a scale
Standard Deviation 1.2
|
1.4 units on a scale
Standard Deviation 1.6
|
|
Itch by VAS Itch Intensity at 3 Months (Visit 4)
3 Months (Visit 4), 270 seconds
|
0.7 units on a scale
Standard Deviation 1.1
|
0.9 units on a scale
Standard Deviation 1.4
|
|
Itch by VAS Itch Intensity at 3 Months (Visit 4)
3 Months (Visit 4), All Times
|
2.6 units on a scale
Standard Deviation 2.4
|
3.2 units on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Baseline, 1 week, 1 month, 3 monthsA secondary endpoint is to see if Botox has a relieving effect on heat pain using a pain visual analog scale (VAS) intensity scale as an outcome measure. The pain VAS intensity scale ranges from a minimum of 0 (no pain - best) to a maximum of 10 (maximum pain - worst). Participants will rate pain intensity after pain is induced with a heat thermode.
Outcome measures
| Measure |
Botox
n=35 Participants
10 units of Botox intradermally injected into one forearm
|
Saline
n=35 Participants
Saline vehicle intradermally injected into the other forearm
|
|---|---|---|
|
Change in Heat Pain Relief by VAS Pain Intensity Reporting After 1 Week, 1 Month, and 3 Months After Treatment
3 Months
|
4.1 units on a scale
Standard Deviation 2.4
|
4.3 units on a scale
Standard Deviation 2.5
|
|
Change in Heat Pain Relief by VAS Pain Intensity Reporting After 1 Week, 1 Month, and 3 Months After Treatment
All Visits
|
3.8 units on a scale
Standard Deviation 2.4
|
4.0 units on a scale
Standard Deviation 2.4
|
|
Change in Heat Pain Relief by VAS Pain Intensity Reporting After 1 Week, 1 Month, and 3 Months After Treatment
Baseline
|
3.6 units on a scale
Standard Deviation 2.4
|
3.7 units on a scale
Standard Deviation 2.2
|
|
Change in Heat Pain Relief by VAS Pain Intensity Reporting After 1 Week, 1 Month, and 3 Months After Treatment
1 Week
|
3.7 units on a scale
Standard Deviation 2.5
|
3.7 units on a scale
Standard Deviation 2.5
|
|
Change in Heat Pain Relief by VAS Pain Intensity Reporting After 1 Week, 1 Month, and 3 Months After Treatment
1 Month
|
3.7 units on a scale
Standard Deviation 2.5
|
4.1 units on a scale
Standard Deviation 2.6
|
Adverse Events
Botox
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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
Susan G. Fisher, M.S., Ph.D., Associate Dean and Director, Temple Clinical Research Institute
Lewis Katz School of Medicine at Temple University
Phone: 215-707-3577
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place