Botulinum Toxin Reduces Pain of Skin Leiomyomas

Edward W. Cowen, MD, MHSc Dermatology Branch, Center for Cancer Research National Cancer Institute Bethesda, Interview with:
Edward W. Cowen, MD, MHSc
Dermatology Branch, Center for Cancer Research
National Cancer Institute
Bethesda, Maryland

Medical Research: What is the background for this study?

Dr. Cowen: Cutaneous leiomyomas are benign smooth muscle proliferations that are associated with pain that is typically not well-controlled by topical remedies or systemic pain medication. Hereditary leiomyomatosis and renal cell cancer is a rare syndrome in which patients may have dozens or even hundreds of these painful tumors. We sought to determine if botulinum toxin injected directly into leiomyomas may ameliorate discomfort and improve quality of life in patients who experience significant pain from cutaneous leiomyomas.

Medical Research: What are the main findings?

Dr. Cowen: In a double-blinded placebo-controlled study, we found that injection of botulinum toxin was associated with improved skin-related quality of life (p = 0.007) and decreased skin-specific pain (p = 0.048) on the Dermatology Life Quality Index. A trend for decreased pain (p = 0.06) by visual analog score was reported in the botulinum toxin treated group compared to the placebo group.

Medical Research: What should clinicians and patients take away from your report?

Dr. Cowen: In this small pilot study, we provide preliminary evidence that botulinum toxin improves quality of life and may exhibit analgesic qualities in patients with significant pain related to cutaneous leimyomas. To our knowledge, this is the first clinical trial demonstrating such a benefit with botulinum toxin for leimyoma skin-related pain.

Medical Research: What recommendations do you have for future research as a result of this study?

Dr. Cowen: The mechanisms underlying the benefit of botulinum toxin for this and other pain disorders remains unclear. Botulinum toxin injection into cutaneous leimyomas is associated with discomfort and, therefore, other routes of administration, such as topical formulation of botulinum toxin, could potentially avoid the discomfort of intralesional injection.


Naik HB, Steinberg SM, Middelton LA, et al. Efficacy of Intralesional Botulinum Toxin A for Treatment of Painful Cutaneous Leiomyomas: A Randomized Clinical Trial. JAMA Dermatol. Published online August 05, 2015. doi:10.1001/jamadermatol.2015.1793.

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Edward W. Cowen, MD, MHSc (2015). Botulinum Toxin Reduces Pain of Skin Leiomyomas 

Last Updated on August 7, 2015 by Marie Benz MD FAAD