Use of Topical Liquid Diclofenac Following Laser Microporation of Cutaneous Neurofibromas in Patients With NF1
Status:
Completed
Trial end date:
2017-06-30
Target enrollment:
Participant gender:
Summary
This is an open, controlled, prospective, proof-of-concept study, in 7 patients presenting
NF1 and cutaneous neurofibromas. This study will include three treatment visits to the study
center and three follow-up visits. Treatment will consist of two stages: neurofibroma
microporation using the laser device, followed by topical application of one drop of
diclofenac 25mg/ml on the surface of the neurofibroma; followed by re-application of one drop
of diclofenac, twice daily, for three days. The applications subsequent to the first
application will be performed by the patients. Subjects will return to the study center at
three day intervals (Assessments 2 & 3) for new microporation and topical diclofenac
application, followed by at-home topical diclofenac application for three more days.
Assessment 4 will take place 3 days after Assessment 3. Assessment 5 will take place 7 days
after the end of the treatment period and Assessment 6 at 30 days after the last application
of study drug. The primary efficacy variable in this study is the inflammatory process with
the presence of tissue necrosis. The primary safety variable is the occurrence of adverse
events considered to be associated with the study drug, occurring during the treatment
period.