Author(s)

Mauro Geller^1,2,3, Aguinaldo Bonalumi Filho^4,5, Lisa Oliveira¹, Allan E. Rubenstein⁶, Luiz Guilherme Darrigo Jr.⁷, David Azulay⁸, Allan Bernacchi⁹, Marcia Gonçalves Ribeiro³, Karin Soares Gonçalves Cunha¹⁰

¹Immunology Department, Fundação Educacional Serra dos órgãos (UNIFESO), Teresópolis, Brazil.
²Clinical Immunology, Instituto de Pós-Graduação Médica Carlos Chagas (IPGMCC,) Rio de Janeiro, Brazil.
³Medical Genetics Service, IPPMG-Universidade Federal Rio de Janeiro, Rio de Janeiro, Brazil.
⁴Hospital Naval Marcílio Dias, Rio de Janeiro, Brazil.
⁵Sociedade Evangélica Beneficiente de Curitiba Outpatient Unit, Curitiba, Brazil.
⁶NYU Langone Medical Center, New York, NY, USA.
⁷Bone Marrow Transplant Unit, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo (USP), Ribeirão Preto, Brazil.
⁸Pontifica Universidade Católica do Rio de Janeiro (PUC-RJ), Rio de Janeiro, RJ, Brazil.
⁹Plastic Surgery Post-Graduation, PUC-RJ, Rio de Janeiro, Brazil.
¹⁰Universidade Federal Fluminense (UFF), Rio de Janeiro, Brazil.

The objectives of this study were to assess the safety and efficacy of intralesionally administered diclofenac in the treatment of cutaneous neurofibromas in patients with NF1. This was a proof-of-concept, prospective, safety and efficacy study of the effect of intralesionally administered diclofenac 25 mg/ml given once a week to 3 target cutaneous neurofibromas for 4 consecutive weeks. Overall, there was no significant change in neurofibroma size. During the study, some treated lesions developed signs of necrosis and fell off after a few weeks, but none of the control neurofibromas fell off. There were no significant changes in patient’s vital signs. A few adverse events occurred, mostly at the injection sites. During the study, some neurofibromas developed necrosis after the diclofenac injections and eventually detached from the patient. Overall, diclofenac was well tolerated, suggesting minimal systemic exposure, which required confirmation and further studies, including bioavailability analysis.

Neurofibromatosis Type 1, Cutaneous Neurofibromas, Diclofenac Sodium

Geller, M. , Bonalumi Filho, A. , Oliveira, L. , Rubenstein, A. , Darrigo Jr., L. , Azulay, D. , Bernacchi, A. , Ribeiro, M. and Gonçalves Cunha, K. (2015) A Proof-of-Concept Assessment of the Safety and Efficacy of Intralesional Diclofenac in the Treatment of Cutaneous Neurofibromas. International Journal of Clinical Medicine, 6, 975-983. doi: 10.4236/ijcm.2015.612128.