ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    09-C-0072
Previous Study | Return to List | Next Study

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 ]

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

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

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 ]

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 ]

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

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

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 ]

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 ]

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

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 ]

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


  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