Advice for 8yr old patient with onychomycosis

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Can anyone help? I have an eight-year-old patient with severe fungal nail infection, which is making her feel very self conscious and reluctant to do sports at school. All nails are affected to a certain degree, although several have progressed towards the proximal nail fold and affecting the full thickness of the nail. The Patient has been using Amorolofene lacquer intermittently. Other than continuing to use the Amorolofene are there any other treatments available? - I do believe that oral terbinafine is unlicensed for children and due to the side effects is not desirable.

Jp

 

Hi John - what was the original cause of the O/M in the first place? i.e. is she immunodeficient or immunosurpressed for any reason?

 

Thanks for your reply. The patient has no history of immunosupression or immunodeficiency. Patient was seen by GP some time ago. No such tests were performed. Father has long history of tinea pedis and grandmother has superficial o/m.

 

Dr. Peart:

You may want to look at Gris-Peg that is FDA approved for fungal infections in children.

It is produced by Pedinol, and has Pediatric dosing.

http://www.pedinol.com/GrisPEG/grispeg.htm

More info below.


INDICATIONS
Gris-PEG® (griseofulvin ultramicrosize) is indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails), when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitalis,Trichophyton verrucosum, Trichophyton megnini, Trichophyton gallinae, Trichophyton crateriform, Trichophyton sulphureum, Trichophyton schoenleini, Microsporum audouini, Microsporum canis, Microsporum gypseum and Epidermophyton floccosum. NOTE: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical agents alone. Griseofulvin is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor and nocardiosis.


Pediatric Use
Approximately 3.3 mg per pound of body weight per day of ultramicrosize griseofulvin is an effective dose for most pediatric patients. On this basis, the following dosage schedule is suggested: Children weighing 35-60 pounds - 125 mg to 187.5 mg daily. Pediatric patients weighing over 60 pounds - 187.5 mg to 375 mg daily. Children and infants 2 years of age and younger - dosage has not been established.

Clinical experience with griseofulvin in children with tinea capitis indicates that a single daily dose is effective. Clinical relapse will occur if the medication is not continued until the infecting organism is eradicated.


Eric Bornstein DMD
Chief Science Officer
Nomir Medical Technologies

 

Thank you for the information Dr. Bornstein. Although the British National Formulary does list Grisofulvin as suitable for pediatric treatment of dermatophyte infections there appears to a reluctance on behalf of the childs General Practitioner to prescribe the oral antifungals due to the possible side effects; this seems to be a common view amongst many GP's. Also the parents feel reluctant to accept the risk of possible side effects no matter how small they may be. Unfortunately I feel that this problem will not resolve unless some sort of oral medication is considered.

 

Dr. Peart:

Understood.

If there is any interest in orals on the parents part, (below) is a recent large study, comparing Terbinafine to Griseofulvin in a sizeable pediatric population with a good safety profile.

Good luck.

Eric Bornstein DMD
Chief Science officer
Nomir Medical Technologies


J Am Acad Dermatol. 2008 Jul;59(1):41-54. Epub 2008 Apr 18.

Terbinafine hydrochloride oral granules versus oral griseofulvin suspension in children with tinea capitis: results of two randomized, investigator-blinded, multicenter, international, controlled trials.
Elewski BE, Cáceres HW, DeLeon L, El Shimy S, Hunter JA, Korotkiy N, Rachesky IJ, Sanchez-Bal V, Todd G, Wraith L, Cai B, Tavakkol A, Bakshi R, Nyirady J, Friedlander SF.

Department of Dermatology, University of Alabama, Birmingham, Alabama 35294-0009, USA. beelewski@aol.com

BACKGROUND: Although griseofulvin is currently considered the primary antifungal agent used to treat tinea capitis in many countries, increasingly higher doses and longer durations of treatment are becoming necessary to achieve effective treatment. Alternative antifungal therapies with shorter/simpler treatment regimens may be important to develop for this indication. OBJECTIVE: To compare the efficacy and safety of a new pediatric formulation of terbinafine hydrochloride oral granules with griseofulvin oral suspension in the treatment of tinea capitis. METHOD: Children (4-12 years of age) with clinically diagnosed and potassium hydroxide microscopy-confirmed tinea capitis were randomized in two identical studies (trial 1, trial 2) to once-daily treatment with terbinafine (5-8 mg/kg; n = 1040) or griseofulvin administered per label (10-20 mg/kg; n = 509) for a period of 6 weeks followed by 4 weeks of follow-up. End-of-study complete cure (negative fungal culture and microscopy with Total Signs and Symptoms Score [TSSS] = 0), and mycologic (negative culture and microscopy) and clinical cure (TSSS = 0) were primary and secondary efficacy variables, respectively. Efficacy analysis was based on pooled data using modified intent-to-treat population (those who received at least one dose of study drug and had positive baseline fungal culture, N = 1286). Safety assessments included monitoring of the frequency and severity of adverse events (AEs). RESULTS: Rates of complete cure and mycologic cure were significantly higher for terbinafine than for griseofulvin (45.1% vs 39.2% and 61.5% vs 55.5%, respectively; P < .05). A majority (86.7%) of patients received griseofulvin, 10 to 19.9 mg/kg per day; complete cure rate was not found to be higher among patients who received griseofulvin more than 20 mg/kg per day compared with those who received less than 20 mg/kg per day. Complete cure rate was statistically significantly greater for terbinafine compared to griseofulvin in trial 1 (46.23% vs 34.01%) but not in trial 2 (43.99% vs 43.46%). On the basis of pooled data, clinical cure was higher for terbinafine than for griseofulvin, but the difference was not found to be statistically significant (P = .10). Subgroup analyses revealed that terbinafine was significantly better than griseofulvin for all cure rates--mycologic, clinical, and complete--among patients with Trichophyton tonsurans but not Microsporum canis (P < .001). For M. canis, mycologic and clinical cure rates were significantly better with griseofulvin than with terbinafine (P < .05). Approximately 50% of patients in each group reported an AE; almost all were mild or moderate in severity. Nasopharyngitis, headache, and pyrexia were most common in both groups. There were no drug-related serious AEs, no deaths, and no significant effects on weight or laboratory parameters, including liver transaminases. LIMITATIONS: In retrospect, a difference in the distribution of infecting microorganisms between the two trials was a limitation. Stringent adherence to griseofulvin doses recommended by prescribing information but smaller than those used in current clinical practice, and exclusion of adjuvant therapies such as shampoos or topical agents, which are routinely used in practice, are other limitations. CONCLUSIONS: Data from this largest pediatric trial of terbinafine to date indicate that terbinafine is efficacious and well tolerated in the treatment of tinea capitis. Terbinafine is an effective alternative to griseofulvin against T. tonsurans tinea capitis.

 

For an 8 year old child to have severe O/M, I would think there is something else going on.

From my understanding topical Amorolfine is not reccomended when more than 80% of the nail is infected or when multiple nails are involved. Saying that I still find it the best topical treatment.

 

:good:

Agreed, however topical Amorolfine may be replaced by topical Gordochom (Undecenoic Acid 250mg/mL, Chloroxylenol 30mg/mL in a penetrating oil base) if concerns regarding cost and long term use limitations apply for the patient.

Oral terbinafine would also be high on my consideration list. Finally and most drastically surgical ablation of the nails with phenol application to the nail plate (not nail matrix) area.

You don't randomly get bilateral complete (10 toes) onycomycoses at 8 years of age without a predisposing factor.

Considered psoriatic nail?

 

Has there been 100% confirmation that it is onyhomycosis,ie; mycology culture of nail samples?

 

today an 11 year old patient presented to me with full thickness onychomycosis to all digits B/L. He has had it for 5 years.
He has had mycology performed on nail sample on 2 occasions previous to seeing me with both results indicating positive diagnosis for o/m.

He has used Locyryl for 2 years on a weekly basis, diligently (his mother informs me).
I have noticed that the posts previous to mine are more than a few years old, and was wondering if any new development on treating children with systemic medication ie oral Lamisil ? I noticed that MIMs indicated as a precaution in treating children though I am reluctant to support the use in this young fellow.

has any new studies been conducted or could the brains trust recommend an alternative treatment?

regards

Bren

 

As an aside to this i am concerned at the number of young, under 10 , girls using nail varnish.

The number of young women, under 30, with om all have one common presentation.

Habitual use of nail varnish.:butcher:

The price women pay for vanity is indeed high.

David

 

Hi,

I've been reading this thread and I wonder what you've done to treat the patient. In Portugal we often use Ciclopirox olamine (commercial name Mycoster from Pierre Fabre, Switzerland (I think)) , to treat nail fungus, with good results. From my point of view oral Grisofulvin or Terbinafine are the last option, even if it takes a year to treat the patient. I recommend always 6-6 months consultation. Alternatively, there's also Laser/LED therapy, with the best results.

 

I honestly do not know about this condition, but I would really like to thank everyone especially John for bring out this kind of discussion as I am now very aware of this kind of condition. This kind of condition really gives me a lot of concern but I learned so much.