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Original Investigation |

Efficacy of Intralesional Botulinum Toxin A for Treatment of Painful Cutaneous Leiomyomas A Randomized Clinical Trial

Haley B. Naik, MD, MHSc1; Seth M. Steinberg, PhD2; Lindsay A. Middelton, RN, CGC3; Stephen M. Hewitt, MD, PhD4; Rena C. Zuo, BA1; W. Marston Linehan, MD3; Heidi H. Kong, MD, MHSc1; Edward W. Cowen, MD, MHSc1
[+] Author Affiliations
1Dermatology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland
2Biostatistics and Data Management Section, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland
3Urologic Surgery and the Urologic Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland
4Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland
JAMA Dermatol. 2015;151(10):1096-1102. doi:10.1001/jamadermatol.2015.1793.
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Importance  Cutaneous leiomyomas can be associated with severe paroxysmal pain in which nerve conduction may have a key role. Medical management of painful cutaneous leiomyomas is generally unsatisfactory.

Objective  To assess the efficacy of intralesional botulinum toxin A in the management of pain associated with cutaneous leiomyomas.

Design, Setting, and Participants  Randomized, double-blind, placebo-controlled pilot study conducted from January 5, 2009, to March 27, 2014. The setting was a single-center study at the National Institutes of Health among participants 18 years or older with cutaneous leiomyomas characterized by pain at least once weekly and pain of at least 4 on a pain scale ranging from 0 to 10.

Interventions  Eighteen participants were randomized to receive intralesional botulinum toxin A (5 U per 1 cm2) or equivalent volumes of intralesional saline placebo.

Main Outcomes and Measures  The primary outcomes were the differences in average lesional pain assessed by the Brief Pain Inventory and visual analog scale before and after ice provocation over a 4-week period.

Results  No significant difference in average lesional pain was observed between the study arms. Decreased pain was reported in the botulinum toxin vs placebo arms by visual analog scale scores before ice provocation (median, 0.00; range, −3.30 to 0.70 for botulinum toxin and median, 0.40; range, −1.30 to 1.50 for placebo; P = .06); however, this finding was nonsignificant. No significant difference was observed in change in pain after ice provocation. A significant difference was seen between the arms in skin-related quality of life by total Dermatology Life Quality Index (median, −4.00; range, −8.00 to 2.00 for botulinum toxin and median, 0.00; range, −1.00 to 4.00 for placebo; P = .007) and with the specific skin pain–related question on the Dermatology Life Quality Index (median, −1.00; range, −2.00 to 1.00 for botulinum toxin and median, 0.00; range, −1.00 to 0.00 for placebo; P = .048). No significant difference was found in pain as ascertained by Patient Global Impression of Change at week 4. No serious adverse events related to botulinum toxin use were observed.

Conclusions and Relevance  The use of botulinum toxin to treat painful cutaneous leiomyomas was associated with improved quality of life and with a trend toward improved pain at rest.

Trial Registration  clinicaltrials.gov Identifier: NCT00971620

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Figure 1.
Flow Diagram of Patient Enrollment and Progress Through the Study

RCC indicates renal cell carcinoma.

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Figure 2.
Primary and Secondary Outcomes Assessed at Week 4

In A through F, vertical lines ending in small horizontal line segments represent the 25th to 75th percentiles; the medians are shown as a plus sign when the data are adequately spread to distinguish these from the first or third quartiles. BPI indicates brief pain inventory; DLQI, Dermatology Life Quality Index; VAS, visual analog scale.

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Figure 3.
Secondary Outcomes Assessed at Week 24

In A and B, the plus sign refers to the median value. The vertical lines ending in small horizontal line segments represent the 25th to 75th percentiles. BPI indicates brief pain inventory; VAS, visual analog scale.

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Figure 4.
Immunohistochemical Staining of Cutaneous Leiomyomas for Acetylcholinesterase and c-fos Before and After Botulinum Toxin Administration

All images are original magnification ×320. Comparing A and C, increased acetylcholinesterase expression in nerve fibers is observed after botulinum toxin administration, consistent with increased spread of acetylcholinesterase. Comparing B and D, decreased c-fos expression in the leiomyoma tumor cells is observed after botulinum toxin administration, consistent with decreased neuronal activation.

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