A Proof-of-Concept Assessment of the Safety and Efficacy of Intralesional Diclofenac in the Treatment of Cutaneous Neurofibromas
Mauro Geller1,2,3, Aguinaldo Bonalumi Filho4,5, 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.
DOI: 10.4236/ijcm.2015.612128   PDF   HTML   XML   4,713 Downloads   5,364 Views   Citations

Abstract

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.

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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.

Conflicts of Interest

The authors declare no conflicts of interest.

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