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Trial record 1 of 1 for:    09-C-0072
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Randomized Pilot Study for the Treatment of Cutaneous Leiomyomas With Botulinum Toxin

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: NCT00971620
Recruitment Status : Completed
First Posted : September 4, 2009
Results First Posted : January 6, 2015
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Edward Cowen, M.D., National Institutes of Health Clinical Center (CC)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Cutaneous Leiomyomas
Hereditary Leiomyomatosis and Renal Cell Cancer
Interventions: Biological: Botulinum toxin type A
Other: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
BTX-A BTX-A intralesional injection
Placebo/Saline Saline intralesional injection

Participant Flow:   Overall Study
    BTX-A   Placebo/Saline
STARTED   9   9 
COMPLETED   9   9 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BTX-A BTX-A intralesional injection
Placebo/Saline Saline intralesional injection
Total Total of all reporting groups

Baseline Measures
   BTX-A   Placebo/Saline   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   9   18 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      8  88.9%      9 100.0%      17  94.4% 
>=65 years      1  11.1%      0   0.0%      1   5.6% 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.4  (15.6)   45.5  (11.4)   47.0  (13.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      8  88.9%      6  66.7%      14  77.8% 
Male      1  11.1%      3  33.3%      4  22.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      9 100.0%      9 100.0%      18 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      9 100.0%      9 100.0%      18 100.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   9   9   18 
Leiomyoma Distribution 
[Units: Participants]
Count of Participants
     
Single   1   3   4 
Segmental   7   6   13 
Disseminated   1   0   1 
Location of Lesions 
[Units: Participants]
Count of Participants
     
Neck   1   0   1 
Torso   6   4   10 
Extremity   2   5   7 
Volume of Drug Administered 
[Units: mL]
Mean (Standard Deviation)
 2.41  (0.70)   1.12  (0.38)   1.76  (.54) 


  Outcome Measures

1.  Primary:   Change in Worst Lesional Pain in the Past Week Based on Brief Pain Inventory   [ Time Frame: Between week 0 and week 4 ]

Measure Type Primary
Measure Title Change in Worst Lesional Pain in the Past Week Based on Brief Pain Inventory
Measure Description Change in worst lesional pain in the past week based on Brief Pain Inventory (BPI) from Week 0 to Week 4 in treated patients versus controls. The BPI uses an arbitrary units on a 0-10 scale. For the purposes of the statistical calculation, a difference of 1 standard deviation between groups at baseline vs. week 4 was considered significant. Any BPI value above zero (no pain) is abnormal. The mean change indicates mean change in pain score.
Time Frame Between week 0 and week 4  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BTX-A BTX-A intralesional injection
Placebo/Saline Saline intralesional injection

Measured Values
   BTX-A   Placebo/Saline 
Participants Analyzed   9   9 
Change in Worst Lesional Pain in the Past Week Based on Brief Pain Inventory 
[Units: Units on a scale]
Mean (Standard Error)
 -2.50  (0.46)   -1.26  (0.53) 

No statistical analysis provided for Change in Worst Lesional Pain in the Past Week Based on Brief Pain Inventory



2.  Primary:   Median Change in Average Pain Between Two Arms   [ Time Frame: Between weeks 0 and week 4 ]

Measure Type Primary
Measure Title Median Change in Average Pain Between Two Arms
Measure Description Change in average pain was assessed by the Brief Pain Inventory (BPI). The BPI is a validated pain assessment tool that assesses severity of pain, location of pain, impact of pain on daily functions, pain medications, and amount of pain relief in the past 24 hours or past week (e.g. scale of 0-10 (worst pain)).
Time Frame Between weeks 0 and week 4  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BTX-A BTX-A intralesional injection
Placebo/Saline Saline intralesional injection

Measured Values
   BTX-A   Placebo/Saline 
Participants Analyzed   9   9 
Median Change in Average Pain Between Two Arms 
[Units: Score]
Median (Full Range)
 0.00 
 (-6.00 to 2.00) 
 0.00 
 (-5.00 to 3.00) 


Statistical Analysis 1 for Median Change in Average Pain Between Two Arms
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Wilcoxon rank sum test
P Value [4] .70
Hodges-Lehmann [5] 0.00
95% Confidence Interval -2.00 to 4.00
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



3.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 37 months ]

Measure Type Secondary
Measure Title Number of Participants With Adverse Events
Measure Description Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Time Frame 37 months  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BTX-A BTX-A intralesional injection
Placebo/Saline Saline intralesional injection

Measured Values
   BTX-A   Placebo/Saline 
Participants Analyzed   9   9 
Number of Participants With Adverse Events 
[Units: Participants]
 4   5 

No statistical analysis provided for Number of Participants With Adverse Events



4.  Secondary:   Visual Analog Scale (VAS) of Patient Perceived Pain at Leiomyoma Site Prior to Ice Provocation at Week 0 vs. Week 4   [ Time Frame: Week 0 vs. week 4 ]

Measure Type Secondary
Measure Title Visual Analog Scale (VAS) of Patient Perceived Pain at Leiomyoma Site Prior to Ice Provocation at Week 0 vs. Week 4
Measure Description The VAS is a commonly used validated tool for assessment of pain. For this measure, a 10-cm VAS was used to assess current patient pain/discomfort before application of ice to study lesions at week 0 and week 4. A clinically meaningful change in chronic pain intensity using the VAS has been determined as a reduction of 2 points or 30%. Range is 0-10; 0 is no pain and 10 is worst possible pain.
Time Frame Week 0 vs. week 4  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BTX-A BTX-A intralesional injection
Placebo/Saline Saline intralesional injection

Measured Values
   BTX-A   Placebo/Saline 
Participants Analyzed   9   9 
Visual Analog Scale (VAS) of Patient Perceived Pain at Leiomyoma Site Prior to Ice Provocation at Week 0 vs. Week 4 
[Units: Score]
Median (Full Range)
 0.00 
 (-3.30 to 0.70) 
 0.40 
 (-1.30 to 1.50) 


Statistical Analysis 1 for Visual Analog Scale (VAS) of Patient Perceived Pain at Leiomyoma Site Prior to Ice Provocation at Week 0 vs. Week 4
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Wilcoxon rank sum test
P Value [4] .06
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



5.  Secondary:   Comparison of Change in Skin Related Quality of Life by Total Dermatology Life Quality Index (DLQI) at Week 0 vs. Week 4   [ Time Frame: Week 0 vs. week 4 ]

Measure Type Secondary
Measure Title Comparison of Change in Skin Related Quality of Life by Total Dermatology Life Quality Index (DLQI) at Week 0 vs. Week 4
Measure Description The DLQI is a 10-question quality of life survey which has been extensively validated and frequently used in dermatologic disorders such as atopic dermatitis, acne, and psoriasis. Score is 0-30 based on 10 questions. The higher the score, the more quality of life is impaired.
Time Frame Week 0 vs. week 4  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BTX-A BTX-A intralesional injection
Placebo/Saline Saline intralesional injection

Measured Values
   BTX-A   Placebo/Saline 
Participants Analyzed   9   9 
Comparison of Change in Skin Related Quality of Life by Total Dermatology Life Quality Index (DLQI) at Week 0 vs. Week 4 
[Units: Units on a scale]
Median (Full Range)
 -4.00 
 (-8.00 to 2.00) 
 0.00 
 (-1.00 to 4.00) 


Statistical Analysis 1 for Comparison of Change in Skin Related Quality of Life by Total Dermatology Life Quality Index (DLQI) at Week 0 vs. Week 4
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] WIlcoxon rank sum test
P Value [4] .007
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



6.  Secondary:   Specific Skin Pain-Related Question on the Dermatology Life Quality Index   [ Time Frame: Week 0 vs. week 4 ]

Measure Type Secondary
Measure Title Specific Skin Pain-Related Question on the Dermatology Life Quality Index
Measure Description The DLQI is a 10-question quality of life survey which has been extensively validated and frequently used in dermatologic disorders such as atopic dermatitis, acne, and psoriasis. Participants response to the question "Over the last week, how itchy, sore, painful or stinging has your skin been?" was assessed by the Dermatology Life Quality Index. This outcome refers to a single specific question on the DLQI, so the range for this outcome is 0-3. Lower values in the DLQI indicate less impairment (or greater improvement) in life quality from the skin disease.
Time Frame Week 0 vs. week 4  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BTX-A BTX-A intralesional injection
Placebo/Saline Saline intralesional injection

Measured Values
   BTX-A   Placebo/Saline 
Participants Analyzed   9   9 
Specific Skin Pain-Related Question on the Dermatology Life Quality Index 
[Units: Units on a scale]
Median (Full Range)
 -1.00 
 (-2.00 to 1.00) 
 0.00 
 (-1.00 to 0.00) 


Statistical Analysis 1 for Specific Skin Pain-Related Question on the Dermatology Life Quality Index
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Wilcoxon rank sum test
P Value [4] 0.48
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



7.  Secondary:   Change in Post-Ice Provocation Visual Analog Score (VAS) Between Week 12 and Week 24   [ Time Frame: Between week 12 and 24 ]

Measure Type Secondary
Measure Title Change in Post-Ice Provocation Visual Analog Score (VAS) Between Week 12 and Week 24
Measure Description The VAS is a commonly used validated tool for assessment of pain. The 10-cm VAS was used to assess current patient pain/discomfort before and after application of ice to study lesions. A clinically meaningful change in chronic pain intensity using the VAS has been determined as a reduction of 2 points or 30%. Scale is 0-10. 10 denotes worse pain than 0.
Time Frame Between week 12 and 24  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BTX-A BTX-A intralesional injection
Placebo/Saline Saline intralesional injection

Measured Values
   BTX-A   Placebo/Saline 
Participants Analyzed   9   9 
Change in Post-Ice Provocation Visual Analog Score (VAS) Between Week 12 and Week 24 
[Units: Score]
Median (Full Range)
 4.10 
 (2.50 to 5.90) 
 -0.30 
 (-8.50 to 1.10) 


Statistical Analysis 1 for Change in Post-Ice Provocation Visual Analog Score (VAS) Between Week 12 and Week 24
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Wilcoxon rank sum test
P Value [4] .04
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



8.  Secondary:   Immunohistochemical Staining of Cutaneous Leiomyomas for Acetylcholinesterase (AchE) Before (i.e.,Week 0) and 12 Weeks After Botulinum Toxin Administration   [ Time Frame: Week 0 vs. week 12 ]

Measure Type Secondary
Measure Title Immunohistochemical Staining of Cutaneous Leiomyomas for Acetylcholinesterase (AchE) Before (i.e.,Week 0) and 12 Weeks After Botulinum Toxin Administration
Measure Description AchE staining was scored as 0 (none), 1 (rare), 2 (scattered), or 3 (focal or greater).
Time Frame Week 0 vs. week 12  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BTX-A BTX-A intralesional injection
Placebo/Saline Saline intralesional injection

Measured Values
   BTX-A   Placebo/Saline 
Participants Analyzed   9   9 
Immunohistochemical Staining of Cutaneous Leiomyomas for Acetylcholinesterase (AchE) Before (i.e.,Week 0) and 12 Weeks After Botulinum Toxin Administration 
[Units: Score]
Median (Full Range)
 1.00 
 (0.00 to 2.00) 
 0.00 
 (-1.00 to 0.00) 

No statistical analysis provided for Immunohistochemical Staining of Cutaneous Leiomyomas for Acetylcholinesterase (AchE) Before (i.e.,Week 0) and 12 Weeks After Botulinum Toxin Administration



9.  Secondary:   Immunohistochemical Staining of Cutaneous Leiomyomas for C-fos Before (i.e., Week 0) and 12 Weeks After Botulinum Toxin Administration   [ Time Frame: Week 0 vs. week 12 ]

Measure Type Secondary
Measure Title Immunohistochemical Staining of Cutaneous Leiomyomas for C-fos Before (i.e., Week 0) and 12 Weeks After Botulinum Toxin Administration
Measure Description c-fos, a marker of neuronal activation after pain stimulation, was scored as 0 (none), 1 (scattered), 2 (<66% of tumor cells), or 3 (≥66% of tumor cells).
Time Frame Week 0 vs. week 12  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BTX-A BTX-A intralesional injection
Placebo/Saline Saline intralesional injection

Measured Values
   BTX-A   Placebo/Saline 
Participants Analyzed   9   9 
Immunohistochemical Staining of Cutaneous Leiomyomas for C-fos Before (i.e., Week 0) and 12 Weeks After Botulinum Toxin Administration 
[Units: Score]
Median (Full Range)
 -1.00 
 (-1.00 to 0.00) 
 0.00 
 (0.00 to 1.00) 


Statistical Analysis 1 for Immunohistochemical Staining of Cutaneous Leiomyomas for C-fos Before (i.e., Week 0) and 12 Weeks After Botulinum Toxin Administration
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Wilcoxon rank sum test
P Value [4] .07
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



10.  Secondary:   Percentage of Patients With a Change in Average Pain Score   [ Time Frame: Week 0 score vs. week 4 score ]

Measure Type Secondary
Measure Title Percentage of Patients With a Change in Average Pain Score
Measure Description Average pain was determined from a 0-10 scale question on the Brief Pain Inventory (BPI). 10 denotes worse pain.
Time Frame Week 0 score vs. week 4 score  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BTX-A BTX-A intralesional injection
Placebo/Saline Saline intralesional injection

Measured Values
   BTX-A   Placebo/Saline 
Participants Analyzed   9   9 
Percentage of Patients With a Change in Average Pain Score 
[Units: Percentage of patients]
   
>50% pain reduction   44   22 
≤50% pain reduction   0   11 
No change in pain   22   33 
Increased pain   22   22 
Missing   11   11 

No statistical analysis provided for Percentage of Patients With a Change in Average Pain Score



11.  Secondary:   Percentage of Patients With a Change in Pre-Ice Visual Analog Score (VAS) Between Week 0 and Week 4   [ Time Frame: Week 0 vs. week 4 ]

Measure Type Secondary
Measure Title Percentage of Patients With a Change in Pre-Ice Visual Analog Score (VAS) Between Week 0 and Week 4
Measure Description The VAS is a commonly used validated tool for assessment of pain. The 10-cm VAS was used to assess current patient pain/discomfort before and after application of ice to study lesions. A clinically meaningful change in chronic pain intensity using the VAS has been determined as a reduction of 2 points or 30%. Scale of 0-10. 10 = worse pain.
Time Frame Week 0 vs. week 4  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BTX-A BTX-A intralesional injection
Placebo/Saline Saline intralesional injection

Measured Values
   BTX-A   Placebo/Saline 
Participants Analyzed   9   9 
Percentage of Patients With a Change in Pre-Ice Visual Analog Score (VAS) Between Week 0 and Week 4 
[Units: Percentage of patients]
   
>50% pain reduction   22   11 
≤50% pain reduction   33   0 
No change in pain   0   11 
Increased pain   11   55 
Missing   33   22 

No statistical analysis provided for Percentage of Patients With a Change in Pre-Ice Visual Analog Score (VAS) Between Week 0 and Week 4



12.  Secondary:   Percentage of Patients With a Change in Post-Ice Visual Analog Score (VAS) Between Week 0 and Week 4   [ Time Frame: Week 0 vs. week 4 ]

Measure Type Secondary
Measure Title Percentage of Patients With a Change in Post-Ice Visual Analog Score (VAS) Between Week 0 and Week 4
Measure Description The VAS is a commonly used validated tool for assessment of pain. The 10-cm VAS was used to assess current patient pain/discomfort before and after application of ice to study lesions. A clinically meaningful change in chronic pain intensity using the VAS has been determined as a reduction of 2 points or 30%. Scale is 0-10. 10 = worse pain.
Time Frame Week 0 vs. week 4  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BTX-A BTX-A intralesional injection
Placebo/Saline Saline intralesional injection

Measured Values
   BTX-A   Placebo/Saline 
Participants Analyzed   9   9 
Percentage of Patients With a Change in Post-Ice Visual Analog Score (VAS) Between Week 0 and Week 4 
[Units: Percentage of patients]
   
>50% pain reduction   33   33 
≤50% pain reduction   44   44 
No change in pain   0   0 
Increased pain   22   22 
Missing   0   0 

No statistical analysis provided for Percentage of Patients With a Change in Post-Ice Visual Analog Score (VAS) Between Week 0 and Week 4



13.  Secondary:   Worst Pain Severity   [ Time Frame: Week 0 vs. week 4 ]

Measure Type Secondary
Measure Title Worst Pain Severity
Measure Description Pain severity was assessed by the Brief Pain Inventory (BPI). The BPI is a validated pain assessment tool that assesses severity of pain, location of pain, impact of pain on daily functions, pain medications, and amount of pain relief in the past 24 hours or past week (e.g. scale of 0-10 (worst pain)). This outcome was based on a single 0-10 question on the BPI.
Time Frame Week 0 vs. week 4  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BTX-A BTX-A intralesional injection
Placebo/Saline Saline intralesional injection

Measured Values
   BTX-A   Placebo/Saline 
Participants Analyzed   9   9 
Worst Pain Severity 
[Units: Score]
Median (Full Range)
 -2.25 
 (-5.00 to 0.25) 
 -0.75 
 (-3.75 to 0.50) 

No statistical analysis provided for Worst Pain Severity




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Edward Cowen
Organization: National Cancer Institute
phone: 301-496-4299
e-mail: cowene@mail.nih.gov


Publications of Results:
Other Publications:

Responsible Party: Edward Cowen, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00971620     History of Changes
Obsolete Identifiers: NCT00842725
Other Study ID Numbers: 090072
09-C-0072
First Submitted: September 3, 2009
First Posted: September 4, 2009
Results First Submitted: December 11, 2014
Results First Posted: January 6, 2015
Last Update Posted: April 7, 2017