Use of Topical Liquid Diclofenac Following Laser Microporation of Cutaneous Neurofibromas in Patients With NF1
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ClinicalTrials.gov Identifier: NCT03090971 |
Recruitment Status :
Completed
First Posted : March 27, 2017
Last Update Posted : October 26, 2017
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Condition or disease | Intervention/treatment | Phase |
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Neurofibromatosis 1 Cutaneous Neurofibroma | Drug: Diclofenac Sodium Drug: Saline Solution | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Clinical Assessment of the Use of Topical Liquid Diclofenac Following Laser Microporation of Cutaneous Neurofibromas in Patients With Neurofibromatosis Type 1 |
Actual Study Start Date : | February 15, 2017 |
Actual Primary Completion Date : | March 23, 2017 |
Actual Study Completion Date : | June 30, 2017 |

Arm | Intervention/treatment |
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Experimental: Cutaneous neurofibromas
Each subject will have two treatment neurofibromas and two control neurofibromas. Following microporation, the two treatment neurofibromas will be treated with topical diclofenac while the two control neurofibromas will be treated with topical saline.
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Drug: Diclofenac Sodium
Following microporation, treatment neurofibromas will receive treatment with topical diclofenac Drug: Saline Solution Following microporation, control neurofibromas will receive treatment with topical saline |
- Efficacy - presence of inflammatory process in the treated neurofibromas [ Time Frame: Throughout the 7-day treatment period and subsequent 30-day follow-up period ]Inflammatory process (redness, exculceration)
- Efficacy - presence of tissue necrosis in treated neurofibromas [ Time Frame: Throughout the 7-day treatment period and subsequent 30-day follow-up period ]Presence of tissue necrosis in treated neurofibromas
- Efficacy - neurofibroma size [ Time Frame: Throughout the 7-day treatment period and subsequent 30-day follow-up period ]Reduction in neurofibroma size
- Efficacy - neurofibroma detatchment [ Time Frame: Throughout the 7-day treatment period and subsequent 30-day follow-up period ]Detachment of the treated neurofibroma
- Safety - Adverse events [ Time Frame: Throughout the 7-day treatment period and subsequent 30-day follow-up period ]Occurrence of adverse events considered to be associated with the study drug

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults of both genders, between the ages of 18 and 65;
- NF1, diagnosed clinically by a neurologist, dermatologist, or other specialist knowledgeable about the disease, and defined as:
A known mutation in the gene coding for neurofibromin
or, the presence of 2 of the following 7 clinical manifestations of NF1:
- ≥ 6 café-au-lait macules on the body with diameters greater than 15mm in the greatest diameter;
- two or more neurofibromas of any type or one plexiform neurofibroma
- inguinal or axillary freckling
- two or more Lisch nodules (iris hamartomas)
- optic glioma
- a distinct osseous lesion, such as sphenoid wing dysplasia, pseudoarthrosis of the tibia, macrocephaly, or scoliosis
- a first-degree relative with NF1
- Presence of 4 or more cutaneous neurofibromas measuring 0.5-1.2cm in greatest diameter, present on thorax/abdomen or upper or lower limbs;
- If a woman of childbearing potential, is willing to use a medically acceptable form of contraception (in the judgment of the investigator) for the duration of the study;
- Is able to understand the informed consent form describing the risks of this study, and voluntarily signs the informed consent document;
- Is able to understand and comply with the requirements of the protocol.
Exclusion Criteria:
- Surgical, medical, or investigative treatment for any of the 6 target cutaneous neurofibromas to be evaluated in the study within three months prior to the baseline visit;
- Active infection (bacterial, viral, or fungal) requiring systemic antibiotics within two weeks of the baseline visit;
- Pregnancy or breastfeeding;
- Immunocompromised because of a medical condition;
- Known hypersensitivity to diclofenac or any other NSAID;
- Known hypersensitivity to aspirin;
- has a known hypersensitivity to mannitol, sodium metabisulphite, benzyl alcohol, or propylene glycol;
- Known hypersensitivity to lidocaine;
- Currently receiving or has received with 2 weeks of screening an NSAID (including diclofenac), a COX-2 inhibitor, cyclosporine, methotrexate, an oral anti-diabetic, lithium, digoxin, diuretics, anticoagulants (such as warfarin), or a quinolone antibiotic; except for intralesional diclofenac, these medications will not be allowed during the study; low-dose aspirin used for cardioprotective effects will be allowed;
- Any history of hepatic (including hepatic porphyria) or renal disease resulting in ongoing compromised hepatic or renal function;
- History of a bleeding/coagulation disorder;
- History of gastrointestinal (gastric or intestinal) ulcer disease, Crohn's disease, or ulcerative colitis;
- Laboratory examination at screening that reveals in the opinion of the investigator significant, unstable, and/or untreated renal, hepatic, or metabolic disease/dysfunction;
- White blood cell count at screening that is less than 3000, or a platelet count at screening that is less than 150,000;
- Laboratory evaluation at screening that shows the hemoglobin lower than the lower limit of normal for the laboratory utilized;
- Under treatment for a medical condition that, in the opinion of the investigator, may interfere with the safety of the experimental treatment or with the evaluation of efficacy, including but not limited to cardiovascular and/or respiratory disease;
- Subject is not, in the opinion of the investigator, capable of giving informed consent to participate in the study;
- Subject has received an investigational therapy or procedure for any reason within 30 days prior to screening.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090971
Brazil | |
Fundação Educacional Serra dos Órgãos - UNIFESO | |
Teresópolis, RJ, Brazil, 25964-000 |
Responsible Party: | Mauro Geller, Professor & Chairman of Immunology and Microbiology, Fundação Educacional Serra dos Órgãos |
ClinicalTrials.gov Identifier: | NCT03090971 |
Other Study ID Numbers: |
NX101-02-2016 |
First Posted: | March 27, 2017 Key Record Dates |
Last Update Posted: | October 26, 2017 |
Last Verified: | October 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Neurofibromatoses Neurofibromatosis 1 Neurofibroma Nerve Sheath Neoplasms Neoplasms, Nerve Tissue Neoplasms by Histologic Type Neoplasms Neoplastic Syndromes, Hereditary Neurocutaneous Syndromes Nervous System Diseases Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Peripheral Nervous System Diseases Neuromuscular Diseases |
Peripheral Nervous System Neoplasms Nervous System Neoplasms Diclofenac Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |