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Botulinum Toxin in the Treatment of Raynaud's

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01233999
Recruitment Status : Completed
First Posted : November 4, 2010
Results First Posted : April 21, 2014
Last Update Posted : April 21, 2014
Sponsor:
Information provided by (Responsible Party):
Suephy Chen, MD, Emory University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Raynaud's Syndrome
Intervention Drug: botulinum toxin A
Enrollment 10
Recruitment Details 10 subjects recruited from Emory Dept of Dermatology
Pre-assignment Details all subjects were assigned to group
Arm/Group Title Botox
Hide Arm/Group Description Participants will be randomly assigned to receive 1 injection with Botulinum toxin A, 40 units in either the left or right hand.
Period Title: Overall Study
Started 10
Completed 8
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Lost to Follow-up             1
Arm/Group Title Botox
Hide Arm/Group Description single-drug dosage comparison cross-over study
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
30  (1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
8
  80.0%
Male
2
  20.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Mean Digital Temperature Difference From Baseline
Hide Description 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.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Botox
Hide Arm/Group Description:
single-drug dosage comparison cross-over study
Overall Number of Participants Analyzed 9
Mean (95% Confidence Interval)
Unit of Measure: Celsius
1.30
(0.23 to 2.36)
Time Frame [Not Specified]
Adverse Event Reporting Description A total of 10 participants signed the informed consent, 8 participants completed the trial, 1 participant received study drug and became lost to follow-up and one participant withdrew consent prior to receiving an injection.
 
Arm/Group Title Botox
Hide Arm/Group Description single-drug dosage comparison cross-over study
All-Cause Mortality
Botox
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Botox
Affected / at Risk (%)
Total   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Botox
Affected / at Risk (%)
Total   0/9 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Suephy Chen
Organization: Emory University
Phone: 404-778-3084
Responsible Party: Suephy Chen, MD, Emory University
ClinicalTrials.gov Identifier: NCT01233999     History of Changes
Other Study ID Numbers: IRB00015510
First Submitted: November 2, 2010
First Posted: November 4, 2010
Results First Submitted: July 17, 2013
Results First Posted: April 21, 2014
Last Update Posted: April 21, 2014