The use of botulinum toxin to treat painful cutaneous leiomyomas was associated with improved quality of life with a trend toward improved pain at rest, a new study published online ahead of print in JAMA Dermatology has shown.

Cutaneous leiomyomas are smooth muscle tumors that may occur sporadically or in association with hereditary leiomyomatosis and renal cell cancer (HLRCC), which presents with multiple cutaneous lesions. These tumors can be associated with intense pain that can severely impact patients’ quality of life.

For the double-blind, placebo-controlled pilot study, researchers sought to investigate the efficacy of intralesional botulinum toxin A in the management of pain associated with these cutaneous tumors.

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Researchers enrolled 18 patients and randomly assigned them to receive intralesional botulinum toxin A or intralesional saline placebo.

Results showed no significant difference in average lesional pain between the two treatment arms. Researchers found a nonsignificant decrease in pain in the botulinum toxin group by visual analog scale before ice was applied.

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However, patients who received botulinum toxin reported a significant increase in skin-related quality of life compared with those who received placebo.

In regard to safety, no serious adverse events associated with botulinum toxin were observed.


  1. Naik HB, Steinberg SM, Middleton LA, et al. Efficacy of intralesional botulinum toxin A for treatment of painful cutaneous leiomyomas: a randomized clinical trial. JAMA Dermatol. 2015. [epub ahead of print]. doi: 10.1001/jamadermatol.2015.1793.