Our pilot study of botulinum toxin-A for painful skin leiomyomas will evaluate whether patients receive pain relief after injection. Given the often subjective nature of pain, we have designed the study in a placebo-controlled and double-blinded fashion. For the duration of the study, subjects will rate their pain using standardized pain scoring scales at study visits and through a pain diary. Subjects will also complete quality of life assessments. Due to the rarity of this condition and difficulty for patients to travel to the NIH Clinical Center for protocol participation, accrual has been slow. In fiscal year 2014, we completed enrollment and have initiated analysis of study data and immunohistochemistry studies of skin biopsies.
|Naik, Haley B; Steinberg, Seth M; Middelton, Lindsay A et al. (2015) Efficacy of Intralesional Botulinum Toxin A for Treatment of Painful Cutaneous Leiomyomas: A Randomized Clinical Trial. JAMA Dermatol 151:1096-102|