Randomized Pilot Study for the Treatment of Cutaneous Leiomyomas With Botulinum Toxin

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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.
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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)

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 ]

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
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