Trial Outcomes & Findings for Botulinum Toxin in the Treatment of Raynaud's (NCT NCT01233999)
NCT ID: NCT01233999
Last Updated: 2014-04-21
Results Overview
Each digit temperature was measured and recorded at baseline, and then measured and re-recorded after 3 minute intervals following a 20 second 4 degree Celsius ice bath immersion.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
6 weeks
Results posted on
2014-04-21
Participant Flow
10 subjects recruited from Emory Dept of Dermatology
all subjects were assigned to group
Participant milestones
| Measure |
Botox
Participants will be randomly assigned to receive 1 injection with Botulinum toxin A, 40 units in either the left or right hand.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Botox
Participants will be randomly assigned to receive 1 injection with Botulinum toxin A, 40 units in either the left or right hand.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Botulinum Toxin in the Treatment of Raynaud's
Baseline characteristics by cohort
| Measure |
Botox
n=10 Participants
single-drug dosage comparison cross-over study
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksEach digit temperature was measured and recorded at baseline, and then measured and re-recorded after 3 minute intervals following a 20 second 4 degree Celsius ice bath immersion.
Outcome measures
| Measure |
Botox
n=9 Participants
single-drug dosage comparison cross-over study
|
|---|---|
|
Mean Digital Temperature Difference From Baseline
|
1.30 Celsius
Interval 0.23 to 2.36
|
Adverse Events
Botox
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