fungal nail treatments

tony300+

can anyone tell me if the nail treatments like nailloc and cura nail work;)

RobFowl

Mod note no medical advice to be given or asked for

locum-motion

Curanail is the recently-deregulated OTC equivalent of a prescription only product called Loceryl. It is therefore a licenced medicine, and expirimental data exists that shows that it does work.

The manufacturers of Naloc claim that it is a 'medical device', not a medicine. In my experience, manufacturers claim that something is a 'medical device' because medical devices are not regulated in any way. Why would they do this? Because they have something to fear from regulation. ie the regulator (the Irish Medicines Board (IMB)) might ask them awkward questions if they seek a licence as a medicine. What sort of awkward questions? Well, first among these is that in order to get a Product Authorisation (PA), they'd have to prove that it actually does what they say it does.

If you have a safe product that actually does what you are claiming it does, then you have nothing to fear from the regulator; your product will be awarded a PA once you prove your claims. Whenever I see a product whose literature is claiming "This isn't a medicine, it's a medical device", it would usually ring alarm bells for me.

Talk to your pharmacist or your doctor. If they deem it appropriate, they can sell Curanail/prescribe Loceryl for you.

Bear in mind that treating fungal nail infections is a long term process - the treatment must continue until all affected nail has grown out.

tony300+

thank you very much.

drzhivago

tony300+ wrote: »

can anyone tell me if the nail treatments like nailloc and cura nail work;)

Not giving medical advice but personal experience

I tried the paint on liquids on my own toes and didnt work

Had GP prescribe the tablets and can see it working now, am 2 months in to a 4 month course and not sure if even that will be long enough, must have very slow growing toenails

El_Dangeroso

locum-motion wrote: »

Curanail is the recently-deregulated OTC equivalent of a prescription only product called Loceryl. It is therefore a licenced medicine, and expirimental data exists that shows that it does work.

The manufacturers of Naloc claim that it is a 'medical device', not a medicine. In my experience, manufacturers claim that something is a 'medical device' because medical devices are not regulated in any way.

They most definitely are, you need to carry out clinical investigations to get a CE mark for a medical device.

How can a chemical be classified as a medical device?

locum-motion

El_Dangeroso wrote: »

They most definitely are, you need to carry out clinical investigations to get a CE mark for a medical device.

I can't remember all of the details now but I investigated this a few years ago when a product was launched called Xipisan that claimed to be a 'medical device'. I may have overstated slightly when I said "not regulated in any way". To get a CE mark there's various regulations about materials and manufacturing processes alright, but I could find no mention anywhere of any requirement to actually demonstrate that the 'device' does what its manufacturers claim it does.

El_Dangeroso wrote: »

How can a chemical be classified as a medical device?

Good question. When you find the answer, let me know, coz I'd love to know too. Nevertheless, the fact remains that the packaging of Naloc specifies that it is a Medical Device.

beeno67

locum-motion wrote: »

I can't remember all of the details now but I investigated this a few years ago when a product was launched called Xipisan that claimed to be a 'medical device'. I may have overstated slightly when I said "not regulated in any way". To get a CE mark there's various regulations about materials and manufacturing processes alright, but I could find no mention anywhere of any requirement to actually demonstrate that the 'device' does what its manufacturers claim it does.

BMJ had an article and editorial about medical devices and CE mark in early August. Basically they criticised it completely, saying the CE mark is for toasters and kettles and is pathetic for medical devices. Apparently companies use it as a way to test devices in EU that they would never get approval for in US

El_Dangeroso

locum-motion wrote: »

I can't remember all of the details now but I investigated this a few years ago when a product was launched called Xipisan that claimed to be a 'medical device'. I may have overstated slightly when I said "not regulated in any way". To get a CE mark there's various regulations about materials and manufacturing processes alright, but I could find no mention anywhere of any requirement to actually demonstrate that the 'device' does what its manufacturers claim it does.
.

Depends on the class of medical device. If you're talking a stent (class III) then you have to carry out clinical investigations that are very similar in regulatory rigor to a Investigational Medicinal Product and pre-market approval is mandatory.

I'm also not convinced that the FDA regs mean it's easier to get a device on the market in the EU, I know of one product where it was sufficient to show equivalency in the US but the EU wanted a standalone study.

I'll totally concede class I and II's may be completely different and have far more lax regulation.

I'd say the lines are going to become increasingly blurry, especially with the advent of 'prescribed apps', the FDA are due to release more defined guidelines on this very soon.

Professional Amateur

I've been informed from people in he know... that more often than not these nail lacquers and devices (Nailoc) do not work. Apparently 3-6 months of oral antifingals such as terbinafine (lamisal) does the trick. However these tabs are costly in Ireland.. looking at round 100€ for 3 months plus GP visit fee if you dont have a medical card. However if u happen to be in Spain... then there about half the price and available without prescription...

RobFowl

Professional Amateur wrote: »

I've been informed from people in he know... that more often than not these nail lacquers and devices (Nailoc) do not work. Apparently 3-6 months of oral antifingals such as terbinafine (lamisal) does the trick. However these tabs are costly in Ireland.. looking at round 100€ for 3 months plus GP visit fee if you dont have a medical card. However if u happen to be in Spain... then there about half the price and available without prescription...

Interesting point of view. I come with a fair degree of bias but while terbinafine is a relatively safe drug it is associated with liver function problems and monitoring with blood tests is recommended. I personally would be very uncomfortable with people buying this otc and using it without monitoring. Meta-analysis re safety here http://www.ncbi.nlm.nih.gov/pubmed/17765049 and review (limited access without subscription) here http://www.bmj.com/content/319/7202/71?tab=related

Ultimately the majority of cases are really cosmetic only and using a heavy duty antifungal for 3-6 months is both expensive and often unessecary. IMO topical usage is far superior due to it's reduced side effects and cost. It's also proven to be effective http://www.bmj.com/content/319/7202/79 There was a commentary re this in the BMJ a few years ago as well http://www.bmj.com/rapid-response/2011/10/27/terbinafine-toenail-onychomycosis-effective-treatment-when-should-it-be-us

Also a Dutch paper was somewhat sceptical about the advertising on terbinafine treatment and the motivation behind it http://www.bmj.com/highwire/filestream/400396/field_highwire_article_pdf/0/bmj.38007.711481.F7.full.pdf

Professional Amateur

RobFowl wrote: »

Interesting point of view. I come with a fair degree of bias but while terbinafine is a relatively safe drug it is associated with liver function problems and monitoring with blood tests is recommended. I personally would be very uncomfortable with people buying this otc and using it without monitoring. Meta-analysis re safety here http://www.ncbi.nlm.nih.gov/pubmed/17765049 and review (limited access without subscription) here http://www.bmj.com/content/319/7202/71?tab=related

Ultimately the majority of cases are really cosmetic only and using a heavy duty antifungal for 3-6 months is both expensive and often unessecary. IMO topical usage is far superior due to it's reduced side effects and cost. It's also proven to be effective http://www.bmj.com/content/319/7202/79 There was a commentary re this in the BMJ a few years ago as well http://www.bmj.com/rapid-response/2011/10/27/terbinafine-toenail-onychomycosis-effective-treatment-when-should-it-be-us

Also a Dutch paper was somewhat sceptical about the advertising on terbinafine treatment and the motivation behind it http://www.bmj.com/highwire/filestream/400396/field_highwire_article_pdf/0/bmj.38007.711481.F7.full.pdf

Thats fair enough point i suppose!the course of treatment depends on how bad the infection actually is. i would argue that a very badly infected nail should be treated with terbinafine as i dont believe the lacquers can absorb adequately through a nail bed (sorry i dont have any papers to back me up)... i know its largely a cosmetic issue but a nasty looking nail can cause great embarrassment to a patient and affect self-esteem etc.. not to mention circulatory problems (if very bad).

I agree with your point that these nail lacquers must work to some degree if they have got a license from the IMB. And they obviously have much less side effects due to their topical use. and i would definitely recommend them to be used for a minor infections.

However i dont think that terbinifine requires blood monitoring. I have one friend who got it prescribed (and another who self -presribed and got it in spain). even my friend whom had it prescribed had nothing said to him about blood monitoring by the GP except to watch out for red flag side effects. "Patients prescribed Lamisil tablets should be warned to report immediately any symptoms of unexplained persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain, or jaundice, dark urine or pale stools. Patients with these symptoms should discontinue taking oral terbinafine and the patient's liver function should be immediately evaluated. Lamisil tablets are not recommended for patients with chronic or active liver disease." - www.medicines.ie

Having spoken to my friend who's just completed his 3 month course, it has worked with his 2 infected nails falling off and regrown with no infection.

RobFowl

Professional Amateur wrote: »

However i dont think that terbinifine requires blood monitoring.

The licencing used to include it as recommended but the present advice is more ambiguous http://www.imb.ie/EN/Safety-And-Quality/Advisory,-Warning-And-Recall-Notices/Human-Medicines/Terbinafine-for-Oral-Use.aspx

It says it should be done if if "suspected hepatotoxicity". I'd have little problem with it being dispensed by a pharmacist with the apprporiate advice and follow up, but buying it in Spain (prob with the list of SE in Spanish !!) and no real follow up or monitoring would not be a great idea!

ellie12

I have been using naloc for about three weeks and it has minimal effects in other words it is not great and I have'nt noticed any major improvement. However, there is a treatment called 'biogun' which you can have done at a chiropodist and this does work but is exspensive-about 100 euro for both feet. Its a device that blows an air or lazer type thing onto the nail bed.
Antibiotics that are reccommended are supposed to be hard on the liver.

Rocky Bay

ellie12 wrote: »

I have been using naloc for about three weeks and it has minimal effects in other words it is not great and I have'nt noticed any major improvement. However, there is a treatment called 'biogun' which you can have done at a chiropodist and this does work but is exspensive-about 100 euro for both feet. Its a device that blows an air or lazer type thing onto the nail bed.
Antibiotics that are reccommended are supposed to be hard on the liver.

Ellie please email me, if possible.

mercdave66

Professional Amateur wrote: »

I've been informed from people in he know... that more often than not these nail lacquers and devices (Nailoc) do not work. Apparently 3-6 months of oral antifingals such as terbinafine (lamisal) does the trick. However these tabs are costly in Ireland.. looking at round 100€ for 3 months plus GP visit fee if you dont have a medical card. However if u happen to be in Spain... then there about half the price and available without prescription...

My personal experience with Lamisil tablets. I became really depressed, borderline suicidal after one week of taking these. Took a little while to get right again and I binned the rest. Only available by docs prescription and was expensive, ,<snip>
Still looking for a successful remedy....

locum-motion

mercdave66 wrote: »

... I binned the rest...

NEVER put medicines in the bin. Return them to the pharmacy you got them from to be disposed of properly.

mercdave66 wrote: »

...I would steer clear if I was you...

But you're not him/her, are you?
Just because you suffered from side effects from a medication, does that mean that s/he will?
Does it mean that no other patient should ever take that same medicine ever again?

mercdave66

locum-motion wrote: »

NEVER put medicines in the bin. Return them to the pharmacy you got them from to be disposed of properly.




But you're not him/her, are you?
Just because you suffered from side effects from a medication, does that mean that s/he will?
Does it mean that no other patient should ever take that same medicine ever again?

It is true that I am not him/her. I have spoken to two people who have had similar tendencies during treatment with Lamisil tablets. My 'advice' to steer clear only comes from concern for any other individual who takes these tablets and may experience these side effects.
I'm sure you would agree that to be informed of a potential risk is better than hiding it.
BTW, the list of side effects contained in the packaging does not include depression.

My initial comment was not intended to cause offence or harm and was meant to be helpful.
Your comments have been taken on board and hopefully are of use to someone, somewhere.:)