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This is 'in press' at The Foot: Study to determine the efficacy of Clotrimazole 1% cream for the treatment of onychomycosis in association with the mechanical reduction of the nail plate Published online 20 January 2006.
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Onychomycosis is invasion of the nail by dermatophytes yeasts and moulds [Calderon RA, Hay RJ. Fungicidal activity of human neutrophils and monocytes on dermatophyte fungi Tri. Quinckeanum and Tri. Rubrum. Immunology 1986;61:289–95; Degreef H. Onychomycosis. Br J Clin Pract Syn Suppl 1990;71:91–7; Zaias N. Clinical manifestations of onychomycosis. Clin Exp Dermatol 1992;17(1):6–7]. Causative organisms include T. rubrum and T. mentagrophytes. Fungi invade the distal and lateral under surfaces of the nail. The prevalence of onychomycosis approximates to 5–10% of the population and is increasing significantly in recent years [Stutz A. Allylamine derivatives—a new class of active substances in antifungal chemotherapy. Angew Chem 1987;2:320–8].
Clotrimazole 1% cream is the most commonly prescribed topical antifungal agent in the United Kingdom although its use on nails has not been widely documented. Past inefficiencies may be due to the thickness of the nail plate. The mechanical reduction of the nail minimises the nail as a barrier to the absorption of the cream and increases the permeability of the nail plate.
Subjects were ambulant and healthy with no systemic medication, no past history of anti-fungal agents and an ankle-brachial index indicating sufficient circulation for healing to occur. The infecting organism was identified by microscopy and culture. A total of ninety-two infected nails were isolated over a four-year period. The age range was 60–78 years. Nails were drilled every 14 days by the same operator and the area of infection mapped. Clotrimazole 1% cream was applied twice daily during the trial period and the percentage clearance rate was recorded. After 12 weeks there was an average improvement of 96.2% with the infection in 80% nails completely resolved.
These are remarkable results, far better than anything else published.
I do not have access to the complete article but would be interested in the 'inclusion' criteria for nails, particularly matrix involvement.
I know this is not very 'scientific', but I did try nail debridement almost to bleeding point, on two patients with matrix involvement, every six weeks for at least 12 months, together with Loceryl nail lacquer applied once per week. There was no improvement.
Maybe the key is the agrressive debridement, which was done every 2 weeks (which is unusally frequent). In previous studies it was not clear just how aggressive the debridement was. Maybe we need to revisit the frequency at which the debridement occurs and how aggressive it is (I am aggressive).
__________________
Craig Payne
Department of Podiatry
La Trobe University
Melbourne, Australia http://www.latrobe.edu.au/podiatry
__________________________________________________ ___________________________________ God put me on this earth to accomplish a certain number of things - right now I am so far behind, I will never die.
The views expressed above are those of the author and not that of La Trobe University This is where I am, where are you?
From a quick reading of the abstract it would appear the frequency of the debridement (as you say Craig - every 2 weeks is luxuriously frequent), along with (presumably compliant) twice daily application of the medicament which seems to have done the trick. It is interesting that they chose to use a cream, rather than a lacquer or tincture; presumably the regular disruption to the nail plate surface facilitated the absorption of the cream.
I agree, I would love to see the inclusion criteria. In my experience o/myc of the matrix is a beast to treat with topical mediaments - if the vascular supply is up to it, I would go oral meds.
Damn nice to see some serious research on this topic, given the frequency of presentation in practice - it gives us the chance to implement some EBM at last!
I have tried something similar in my practice. I normally debride the affected nail with slow bur and scapel until all visiable signs of effected nail is gone. This normally exposes the nail bed (reduction is stopped when discomfort of the bed occurs). The client is then advised to use Lamisil spary on the affected nail twice daily. The client then returns in 6/52 for further debridement. I find that the nail is normally clear within the length of time if takes for the affected nail to grow out. I have had some success with this treatment. I find it a useful option for clients who don't want or wouldn't be suitable for oral meds. The treatment is relatively inexpensive, and has good compliance due to ease of application. Further research would be interesting.
An interesting piece of work. As well as the inclusion criteria it would be necessary to see what the criteria for "cure" actually was - clinical, mycological or global. Of course the other important factor is follow up. The main problem in onychomycosis is not cure, drugs will do this, but its relapse and reinfection.
While the more debridement the better is a good rule of thumb,here in the USA there is a problem:Medicare only pays for this every 8 weeks.So how does anyone deal with this?Any input is appreciated.
In my experience you will not get to 'expose' the nail bed.
I use tungsten bits and a dry drill. Debride the nail plate to just before bleeding point.
As the reason for debridement is to allow the topical treatment more intimate contact with the infection, sealing it afterwards would defeat the exercise.
News Bot
Any chance of the full article or more detail on inclusion criteria. This also applies to posters who are achieving success with this method.
I work predominantly with patients who cannot tolerate oral antifungal treatment - due to use of other systemic medications. There is high rate of onychomycosis amongst them. Without wishing to appear to be an 'alternative' practitioner, I started to encourage my patients to try pure Tea tree oil, dropped once or twice daily onto affected nails, after routine debridement at intervals of 2 months.
The results after 2 - 4 months have been very encouraging. Whilst only anecdotal at this stage, the patients motivated to regularly use the oil, showed a distinct 'line' where the nail began to grow from the matirix, without active mycotic infection.
Many have achieved complete clearance of infection, though long term freedom from infection has not been assessed.
The oil seems to achieve excellent penetration of the nail tissues, and is a known anti-fungal.
I normally find the nail bed has seperated from the nail plate. I drill down using a diamond burr slow speed. At the point when you are just about through the nail is when I usually stop. The scapel blade is then used to debride any remaining affected nail. The exposed nail bed has not normally lost it integrity, but is normally sensitive to the touch. The bed needs to stay exposed for the period of treatment. Consequently, you have freed the nail of most of the affected nail and the antifungal spray treats the nail bed any remaining nail.
In non-matrix involved O/M, I debride aggressively, Use hydrogen peroxide to flush out the crevices and then advise pts to use a drop of povidone iodine dialy. The results are similar to the above test, maybe a little less.
I find this treatment especially effective in long standing sub ungual O/M.
Regarding Barbara's post:Tea tree oil is very effective and I had at least 2 or 3 people who insisted on it and swore by it.
Most topicals in and of themselves do not really work.I have a patient who has had mycosis for 50+ years and every topical known to man had been tried.I am getting some results with ciclopirox topical.He still has mycosis.
I now have a couple of good photos of my patient's nails after 3 months of Tea tree treatment. They show excellent clearance of mycotic infection - a distinct "tide-mark"
Of old infected nail growing out and new clean nail coming in. Anyone keen to see these can email me, and I will post them back.
Cheers, barbonice@yahoo.co.nz
The most recently updated systematic review of randomised controlled trials for onychomycosis is:
Crawford F, Ferrari J. Fungal toenail infections. Clinical Evidence 2006;15:1-2. (link)
The search date was June 2005.
Findings:
Oral itraconazole: more effective than placebo, less effective than terbinafine
Oral terbinafine: more effective than placebo, griseofulvin and itraconazole
Oral fluconazole: more effective than placebo, although benefits only modest
Oral griseofulvin: less effective than terbinafine, no different to intraconazole, or ketoconazole
Topical ciclipirox: more effective than placebo, but benefits only modest (34% cure rate versus 10% for placebo)
No RCTs were found for topical amorolfine, butenafine, fluconazole, terbinafine, ketoconazole or tioconazole
Conclusions:
Beneficial: oral terbinafine and oral itraconazole
Likely to be beneficial: oral fluconazole, topical ciclopirox
Unknown effectiveness: oral griseofulvin and ketoconazole, topical amorolfine, butenafine, fluconazole, ketoconazole, terbinafine, tioconazole
The authors state the next update will also assess the role of mechanical debridement.
Re: How important is debridement in onychomycosis?
The impact of aggressive debridement used as an adjunct therapy with terbinafine on perceptions of patients undergoing treatment for toenail onychomycosis. J Dermatolog Treat. 2007;18(1):46-52.
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OBJECTIVE: To determine whether adding aggressive debridement to oral terbinafine for treating toenail onychomycosis impacts patient-reported outcomes (PROs).
MATERIALS AND METHODS: A total of 504 patients were randomized to receive 12 weeks of terbinafine 250 mg/day with or without debridement, with an additional 36-week follow-up. The OnyCOE-t, a validated disease-specific PRO questionnaire, was completed at baseline and weeks 6, 12, 24, and 48. It included six multi-item scales (symptom frequency, appearance problems, physical activities problems, stigma, and treatment satisfaction), and one single-item scale: overall problem. Longitudinal analysis of change was conducted to assess treatment effect. Repeated-measures models adjusted for visit, age, sex, baseline scores, severity and duration of infection; treatment interactions were also tested.
RESULTS: Symptom frequency and treatment satisfaction significantly improved in the terbinafine + debridement group compared with terbinafine alone (p = 0.0395 and p = 0.0077, respectively). Age and sex were often significant explanatory variables, and further analysis of change scores at 12 weeks revealed that females treated with terbinafine + debridement reported significantly less improvement in the physical activities problems (p = 0.0021) and overall problem (p = 0.0112) scores.
CONCLUSIONS: Aggressive debridement, when used as an adjunct therapy with oral terbinafine, improved treatment satisfaction and reduced symptom frequency. The observed sex differences warrant further investigation.
Re: How important is debridement in onychomycosis?
Has anyone tried chemical debridment of mycotic nails? I read (somewhere, sometime) about using a urea paste to basically melt the nail off. Then, presumably, you could begin topical application of whatever.
Re: How important is debridement in onychomycosis?
Hi Phil
Have used this quite a number of times. 40% Urea in a parafin base. Generally I burr the nail quite a way down then apply the urea in a welled pad onto the nail. and bandage securely. Leave it for 4 days and have the pt back. Gentle scapping then allows you to take the nail way back to the nail bed without any discomfort. I then get the pt to apply a topical solution apply a topical ointment as the nail grows back.
Also a very good technique for all manner of thickened nails and deeply fractured nails. Take them back with the burr apply the Urea, scrape away and monitor the regrowth. Simple, effective. My experience is that most nails grow back well and that infected nails improve. You can just burr away the fungal aspect a little aplly the uera and just scrape out the infected bit instead.
Re: How important is debridement in onychomycosis?
Hi Phil and Ian,
there is a fair amount of literature on chemical debridement of nails. Various ointments used under occlusion have been tried. Farber and South (1978) suggested an ointment containing: Urea 40%, white beeswax or paraffin 5%, anhydrous lanolin 20%, white petrolatum 25%, silica gel 10%. Buselmieir (1980) suggested 20% urea combined with 10% salicylic acid. Hay et al (1988) and Bonifaz et al (1995) discussed using 40% urea combined with 1% bifonazole to soften the nail plate and after removal using 1% bifonazole cream daily for 2 months. Many Authors discussing urea refer to its unpleasant odour after a week which may affect patient compliance. The use of an oral therapy (Terbinafine or Itraconazole) together with chemical debridement may possibly be appropriate. Personally I get them on oral therapy, subject to suitability, and concomitantly aggressively debride the nails. To help damp down the mycotic population in the local area I suggest they apply a few spots of pure lemon oil daily. The pure essential oil smells a whole lot better than urea and seems to work as well as anything else when used with debridement and oral therapy (please don't ask me to explain how - I dont know, I'm just a Pod - ask an aromatherapist, they claim it's anti fungal)
Regards, Martin.
References:
Farber, E & South, D.A. (1978) Urea ointment in the non surgical avulsion of nail dystrophies. Cutis22, 689.
Buselmieir, F.J. (1980) Combination urea and salicylic acid ointment nail avulsion in non dystrophic nails: follow up observation Cutis 25, 393-405.
Hay, R.J., Roberts, D., Doherty, V.R. et al (1988) : The topical treatment of onychomycosis using a new combined urea/imidazole preparation. Clinical and experimental Dermatology 17, 164 - 167.
Bonifaz, A,. Guzman, A., Garcia, C. et al (1995) Efficacy and safety of Bifonazole urea in the two phase treatment of onychomycosis. International Journal of Dermatology34, 500-503.
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Darn it Jim, I'm just an old country Chiropodist - not a miracle worker
Re: How important is debridement in onychomycosis?
Hi Ian, you are most welcome. Looking for some history on it's use I did check the subject in one of Granny's old books: A Pharmacoepia for Chiropodists (1937) Le Rossignol, J.N., Holliday, C.B., Faber and Faber. p35. This refers to using a 10 -15% Salicylic Acid Ointment (Unguentum Acidi Salicylici) on Onychomycosis. It doesn't stipulaate a modus operandi however.
Kind Regards,
Martin
__________________
Darn it Jim, I'm just an old country Chiropodist - not a miracle worker
Re: How important is debridement in onychomycosis?
WHEW! What a load of information! Personally I use a product from Gehwol supplied by Canonbury that, because my Dad who lives in America, cannot come to me for treatment (he's been here once), I have sent him a Burr and some Gehwol nail treatment oil. A few months on I asked how he was getting on with the nail reduction (the burr) and he said he didn't have to use it as the Gehwol worked brilliantly. He is a 70yrs old and is on warfarin so the oral meds that were prescribed, and the acid treatment were contraindicated. All other treatments have been unsuccessful, and he now is a happy man with a normal nail (it was only the left hallux)
Glad to hear there is so much interest in this, but as there is, why is it such a mystery for podiatrists to find a be-all end-all cure for this?
Re: How important is debridement in onychomycosis?
Efficacy of debridement alone versus debridement combined with topical antifungal nail lacquer for the treatment of pedal onychomycosis: a randomized, controlled trial.
Malay DS, Yi S, Borowsky P, Downey MS, Mlodzienski AJ. J Foot Ankle Surg. 2009 May-Jun;48(3):294-308.
Quote:
Pedal onychomycosis is a common malady caused by dermatophytes, saprophytes, and yeasts. Traditional treatment options for this condition include toenail debridement, and pharmacological therapies that range from the application of topical agents to the oral administration of antifungal medications. In this study, 55 patients (289 toenails) were randomly allocated to either nail debridement (27 [49.09%] patients) or debridement plus application of topical antifungal nail lacquer (28 [50.91%] patients). The primary outcome was mycological cure, and secondary outcomes included foot-related quality of life, and a number of clinically important toenail characteristics. After a median follow-up of 10.5 months (range, 3.25-14.25) months), patients in the antifungal nail lacquer group improved statistically significantly more than did those in the debridement alone group, and displayed a 76.74% rate of mycological cure. None of the patients in the debridement-only group experienced mycological cure. Variables that statistically significantly decreased the likelihood of cure included yeast on culture, pedal hyperhidrosis, cigarette smoking, involvement of the lunula, and involvement of >50% of the transverse width of the nail. Variables statistically significantly associated with an increased likelihood of cure included intervention before 6 months' duration, treatment at a large, urban practice, black race, and loss of protective sensation
Re: How important is debridement in onychomycosis?
Most funguses are saprophytic - they live on dead material. The nail is dead material, placed on digit ends for protection of the sensitive living material.
Nails are 'historical', have no blood supply and are thus readily invaded by fungal pathogens.
Most of our topical treatments fail because we treat only the historical material. We need to treat the germinal matrices where the nail is made, not the nail itself. Debriding/removing the nailplate reduces the reservoir of infection and gives access to the sterile matrix (nailbed). But only 10% of the nailplate is produced by the sterile matrix. The other 90% of the nail plate is generated by the germinal matrix on the dorsum of the distal phalanx, proximal to the nail.
To kill the fungus we need to target the germinal matrix and nail fold, i.e. paint over the matrix area, not the nail. Topical agents will penetrate better and deeper when applied in this region. Applying them to the nailplate is ineffective. The nailplate is composed principally of keratin and as such is effectively chemical-proof.
Re: How important is debridement in onychomycosis?
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Most funguses are saprophytic -
Perhaps you mean fungi, Johnpod? not that I bear a grudge or anything like that...
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"Perhaps you mean 500th post, Bel? This would be hemi-millenial"
Seriously though that was a and agree that there is no point in applying medication to the nail plate, which is designed to protect the vulnerable subungal tissue, we have to target both the proximal and germinal matrices. Thus, debridement is essential for effective tx.
How important is debridement in onychomycosis?
not that I bear a grudge or anything like that...
and agree that there is no point in applying medication to the nail plate, which is designed to protect the vulnerable subungal tissue, we have to target both the proximal and germinal matrices. Thus, debridement is essential for effective tx.
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