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## Complete Summary

#### GUIDELINE TITLE

Guidelines for treatment of onychomycosis.

#### BIBLIOGRAPHIC SOURCE(S)

Roberts DT, Taylor WD, Boyle J. Guidelines for treatment of
onychomycosis. Br J Dermatol 2003 Mar;148(3):402-10. \[39 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12653730)

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 CONTRAINDICATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Onychomycosis, including distal and lateral subungual onychomycosis
(DLSO), superficial white onychomycosis (SWO), proximal subungual
onychomycosis (PSO), candidal onychomycosis, and total dystrophic
onychomycosis

#### GUIDELINE CATEGORY

Diagnosis\
Management\
Treatment

#### CLINICAL SPECIALTY

Dermatology\
Family Practice\
Internal Medicine

#### INTENDED USERS

Physicians

#### GUIDELINE OBJECTIVE(S)

To provide evidence based guidance for the management of patients with
onychomycosis

#### TARGET POPULATION

Patients with onychomycosis

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Diagnosis**

1.  Nail bed/plate scraping

2.  Punch biopsy

3.  Microscopy and culture

**Treatment**

1.  Topical therapy

    -   Amorolfine (Loceryl®) nail lacquer

    -   Tioconazole (Trosyd®) nail solution

    -   Salicylic acid (Phytex®) paint (considered, but not recommended)

    -   Undecenoates (Monphytol®) paint (considered, but not
        recommended)

2.  Systemic therapy

    -   Griseofulvin (Fulcin®; Grisovin®)

    -   Terbinafine (Lamisil®)

    -   Itraconazole (Sporanox®)

3.  Nail avulsion

#### MAJOR OUTCOMES CONSIDERED

-   Clinical cure rate

-   Mycological cure rate

-   Quality of life

-   Side effects of medications

-   Treatment failure rate

-   Infection with secondary pathogens

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Not stated

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

**Levels of Evidence**

**I**: Evidence obtained from at least one properly designed, randomized
controlled trial.

**II-I**: Evidence obtained from well designed controlled trials without
randomization

**II-ii**: Evidence obtained from well designed cohort or case-control
analytic studies, preferably from more than one centre or research group

**II-iii**: Evidence obtained from multiple time series with or without
the intervention. Dramatic results in uncontrolled experiments (such as
the introduction of penicillin treatment in the 1940s) could also be
regarded as this type of evidence.

**III**: Opinions of respected authorities based on clinical experience,
descriptive studies, or reports of expert committees

**IV**: Evidence inadequate owing to problems of methodology (e.g.
sample size, or length or comprehensiveness of follow-up or conflicts of
evidence)

#### METHODS USED TO ANALYZE THE EVIDENCE

Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

Not stated

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

**Recommendation Grades**

A.  There is good evidence to support the use of the procedure.

B.  There is fair evidence to support the use of the procedure.

C.  There is poor evidence to support the use of the procedure.

D.  There is fair evidence to support the rejection of the use of the
    procedure.

E.  There is good evidence to support the rejection of the use of the
    procedure.

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Draft guidelines are edited by the Therapy Guidelines and Audit
Sub-committee (TGA) and subsequently returned to the task force for
revision. The approved draft version is published in the quarterly
British Association of Dermatologists (BAD) newsletter, and all BAD
members are given the opportunity to respond, positively or negatively,
but hopefully helpfully, within three months of publication. Finalised
guidelines are approved by the TGA and the Executive Committee of the
BAD and finally published in the *British Journal of Dermatology*.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Levels of evidence **(I-IV)** and grading of recommendations **(A-E)**
are defined at the end of the \"Major Recommendations\" field.

**Diagnosis**

Treatment should not be instituted on clinical grounds alone. Although
50% of all cases of nail dystrophy are fungal in origin, it is not
always possible to identify such cases accurately. Treatment needs to be
administered long-term and enough time must elapse for the nail to grow
out completely before such treatment can be designated as successful.
Toenails take around 12 months to grow out and fingernails about 6
months. This is far too long to await the results of therapeutic trial
and, in any case, treatment is not always successful. If the diagnosis
is not confirmed, and improvement does not occur, it is impossible to
tell whether this represents treatment failure or an initial incorrect
diagnosis. Although the cost of diagnostic tests may be deemed high at
times of budgetary constraint, the cost is always small relative to
inappropriate and unnecessary treatment.

Laboratory diagnosis consists of microscopy to visualize fungal elements
in the nail sample and culture to identify the species concerned. The
success or otherwise of such tests depends upon the quality of the
sample, the experience of the microscopist, and the ability of the
laboratory to discriminate between organisms that are likely pathogens,
organisms growing in the nail as saprophytes, and contamination of the
culture plate.

Given that dermatophyte onychomycosis is primarily a disease of the nail
bed rather than of the nail plate, subungual debris taken from the most
proximal part of the infection is likely to yield the best results. In
distal and lateral subungual onychomycosis (DLSO) material can be
obtained from beneath the nail: a small dental scraper is most useful
for this purpose. If the nail is onycholytic, then this can be cut back
and material can be scraped off the underside of the nail as well as
from the nail bed. As much material as possible should be submitted to
the laboratory because of the relative paucity of fungal elements within
the specimen. In superficial white onychomycosis (SWO) the surface of
the infected nail plate can be scraped and material examined directly.
Proximal subungual onychomycosis (PSO) is rare and again should be
scraped with a scalpel blade. However, punch biopsy to obtain a sample
of the full thickness of nail together with the nail bed may be
necessary. Some of the material obtained is placed on a glass slide and
20% potassium hydroxide added. Fifteen to 20 minutes should be allowed
to elapse before examining the sample by direct microscopy. The addition
of Parker\'s blue/black ink may enhance visualization of the hyphae. An
inexperienced observer may very well misdiagnose cell walls as hyphae
and care should be taken to examine all of the specimen, as fungal
elements within the material may be very scanty.

The remaining material should be cultured on Sabouraud\'s glucose agar,
usually with the addition of an antibiotic. The culture plate is
incubated at 28 degrees C for at least 3 weeks before it is declared
negative, as dermatophytes tend to grow slowly.

Direct microscopy can be carried out by the clinician, and higher
specialist training includes teaching of this technique. However, nail
microscopy is difficult and should only be carried out by those who do
it on a regular basis. Fungal culture should always be carried out in a
laboratory experienced in handling mycology specimens, because of
potential pitfalls in interpretation of cultures. It must be remembered
that the most common cause of treatment failure in the U.K. is incorrect
diagnosis, which is usually made on clinical grounds alone. This should
not be further compounded by incorrect laboratory interpretation of
results. Histology is almost never required and its use is usually
confined to other causes of nail dystrophy. Such dystrophies, notably
psoriasis, regularly yield *Candida* yeasts on culture but they are
rarely causal in aetiology of fungal nail infection.

**Reasons for Treatment**

Although dermatophyte onychomycosis is relentlessly progressive there
remains a view among some practitioners that it is a trivial cosmetic
problem that does not merit treatment. In the elderly the disease can
give rise to complications such as cellulitis and therefore further
compromise the limb in those with diabetes or peripheral vascular
disease. While these complications may not be common, they are certainly
serious. The high prevalence of the disease is the result of heavy
contamination of communal bathing places by infected users; disinfecting
the floors of such facilities is very difficult because fungal elements
are protected in small pieces of keratin. It is therefore logical to try
to reduce the number of infected users by effective treatment and thus
reduce disease prevalence. Finally, onychomycosis is a surprisingly
significant cause of medical consultation and of absence from work.
Onychomycosis should not therefore be considered a trivial disease, and
there is a sound case for treatment on the grounds of complications,
public health considerations, and effect on quality of life.

**[Summary of Conclusions]{.underline}**

1.  Treatment should not be commenced before mycological confirmation of
    infection.

2.  Dermatophytes are by far the commonest causal organisms.

3.  Culture of yeasts and nondermatophyte moulds should be interpreted
    carefully in each individual case. In the majority, yeasts are
    likely to be a secondary infection and nondermatophyte moulds to be
    saprophytic in previously damaged nails.

4.  Topical treatment is inferior to systemic therapy in all but a small
    number of cases of very distal infection or in superficial white
    onychomycosis (SWO).

5.  Terbinafine is superior to itraconazole both in vitro and in vivo
    for dermatophyte onychomycosis and should be considered first-line
    treatment, with itraconazole as the next best alternative.

6.  Cure rates of 80-90% for fingernail infection and 70-80% for toenail
    infection can be expected. In cases of treatment failure the reasons
    for such failure should be carefully considered. In such cases
    either an alternative drug or nail removal in combination with a
    further course of therapy to cover the period of regrowth should be
    considered.

**[Topical Agents for Onychomycosis]{.underline}**

  -----------------------------------------------------------------------
  **Agent**                  **Strength of Recommendation and Quality of
                             Evidence**
  -------------------------- --------------------------------------------
  Amorolfine (Loceryl®) nail **B, II-ii**
  lacquer                    

  Tioconazole (Trosyd®) nail **C, II-iii**
  solution                   

  Salicylic acid (Phytex®)   **E, IV**
  paint                      

  Undecenoates (Monphytol®)  **E, IV**
  paint                      
  -----------------------------------------------------------------------

**[Systemic Agents for Onychomycosis]{.underline}**

  -------------------------------------------------------------------------------
  **Drug**          **Advantages**   **Disadvantages**         **Strength of
                                                               Recommendation and
                                                               Quality of
                                                               Evidence**
  ----------------- ---------------- ------------------------- ------------------
  Griseofulvin      Licensed in both Lengthy treatment         **B, I**
                    adults and       necessary in both         
                    children,        fingernail and toenail    
                    inexpensive,     infection; poor cure      
                    extensive        rates; high relapse       
                    experience       rates; no paediatric      
                                     formulation currently     
                                     available;                
                                     contraindicated in lupus  
                                     erythematosus, porphyria, 
                                     and severe liver disease  

  Terbinafine^a^    Fungicidal; high No U.K. licence for       **A, I**
                    cure rates       children; no suspension   
                    (compared with   formulation;              
                    griseofulvin);   idiosyncratic liver and   
                    short duration   skin reactions;           
                    of therapy; good reversible taste          
                    compliance       disturbance in 1:400      
                                     patients                  

  Itraconazole^a^   Active against   Less effective in         **A, I**
                    *Candida         dermatophyte              
                    albicans*;       onychomycosis than        
                    pulsed treatment terbinafine; monitoring   
                    regimens are     of liver function         
                    possible         required for treatment    
                                     durations of longer than  
                                     1 month; not licensed for 
                                     use in children and       
                                     contraindicated in        
                                     pregnancy                 
  -------------------------------------------------------------------------------

^a^Terbinafine has better cure rate and lower relapse rate than
itraconazole for dermatophytes **(A, I)**.

**[Definitions]{.underline}**:

**Levels of Evidence**

**I**: Evidence obtained from at least one properly designed, randomized
controlled trial

**II-I**: Evidence obtained from well designed controlled trials without
randomization

**II-ii**: Evidence obtained from well designed cohort or case-control
analytic studies, preferably from more than one centre or research group

**II-iii**: Evidence obtained from multiple time series with or without
the intervention. Dramatic results in uncontrolled experiments (such as
the introduction of penicillin treatment in the 1940s) could also be
regarded as this type of evidence.

**III**: Opinions of respected authorities based on clinical experience,
descriptive studies, or reports of expert committees

**IV**: Evidence inadequate owing to problems of methodology (e.g.
sample size, or length or comprehensiveness of follow-up or conflicts of
evidence)

**Recommendation Grades**

A.  There is good evidence to support the use of the procedure.

B.  There is fair evidence to support the use of the procedure.

C.  There is poor evidence to support the use of the procedure.

D.  There is fair evidence to support the rejection of the use of the
    procedure.

E.  There is good evidence to support the rejection of the use of the
    procedure.

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for the
treatment recommendations (see \"Major Recommendations\").

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Consistent quality of care for patients with onychomycosis

#### POTENTIAL HARMS

-   Side effects of griseofulvin include nausea and rashes.

-   The manufacturers caution against men fathering a child for 6 months
    after treatment with griseofulvin.

-   Systemic agents may interact with other drugs (see Table 2 of
    original guideline document).

-   Terbinafine may result in idiosyncratic liver and skin reactions and
    reversible taste disturbance.

### CONTRAINDICATIONS

#### CONTRAINDICATIONS

-   Griseofulvin is contraindicated in pregnancy, lupus erythematosus,
    porphyria, and severe liver disease.

-   Itraconazole is contraindicated in pregnancy.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   These guidelines have been prepared for dermatologists on behalf of
    the British Association of Dermatologists and reflect the best data
    available at the time the report was prepared. Caution should be
    exercised in interpreting the data; the results of future studies
    may require alteration of the conclusions or recommendations in this
    report. It may be necessary or even desirable to depart from the
    guidelines in the interests of patients and special circumstances.
    Just as adherence to guidelines may not constitute a defence against
    a claim of negligence, so deviation from them should not necessarily
    be deemed negligent.

-   It is important that these guidelines are used appropriately in that
    they can only assist the practitioner and cannot be used to mandate,
    authorise, or outlaw treatment options. Of course it is the
    responsibility of the practising clinician to interpret the
    application of guidelines, taking into account local circumstances.

-   Guidelines are inherently a fluid, dynamic process and will be
    updated on the British Association of Dermatologists (BAD) Web site
    on a regular basis.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

**Audit Points**

1.  Has a positive culture been obtained before commencing systemic
    therapy for onychomycosis?

2.  Has an appropriate agent been chosen, based on the type of organism
    cultured?

3.  Are arrangements in place for adequate duration of treatment to be
    supplied from hospital or general practitioner?

4.  Has immunosuppression been considered in cases of proximal subungual
    onychomycosis (PSO)?

#### IMPLEMENTATION TOOLS

Audit Criteria/Indicators

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Living with Illness

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Roberts DT, Taylor WD, Boyle J. Guidelines for treatment of
onychomycosis. Br J Dermatol 2003 Mar;148(3):402-10. \[39 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12653730)

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2003 Mar

#### GUIDELINE DEVELOPER(S)

British Association of Dermatologists - Medical Specialty Society

#### SOURCE(S) OF FUNDING

British Association of Dermatologists

#### GUIDELINE COMMITTEE

British Association of Dermatologists Therapy Guidelines and Audit
Subcommittee

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Primary Authors*: D.T. Roberts, Southern General Hospital, Glasgow, UK;
W.D. Taylor, James Cook University Hospital, Middlesbrough, Cleveland,
UK; J. Boyle, Taunton and Somerset Hospital, Taunton, UK

*British Association of Dermatologists Therapy Guidelines and Audit
Committee Members*: N.H. Cox (*Chairman*); A.V. Anstey; C.B. Bunker;
M.J.D. Goodfield; A.S. Highet; D. Mehta; R.H. Meyrick Thomas;
A.D.Ormerod; J.K. Schofield; C.H. Smith

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

David T. Roberts is a member of the Dermatology Advisory Board of
Novartis Pharmaceuticals Ltd. He has given advice to almost all other
manufacturers of antifungal agents and has spoken at symposia organized
by a number of these companies. The other authors have no conflict of
interest.

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the
[British Association of Dermatologists Web
site](http://www.bad.org.uk/healthcare/guidelines/Onychomycosis.pdf).

#### AVAILABILITY OF COMPANION DOCUMENTS

The following is available:

-   Griffiths CE. The British Association of Dermatologists guidelines
    for the management of skin disease Br J Dermatol. 1999
    Sep;141(3):396-7.

Electronic copies: Available in Portable Document Format (PDF) from the
[British Association of Dermatologists Web
site](http://www.bad.org.uk/healthcare/guidelines/Skin_Disease.pdf).

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI on April 20, 2005. The
information was verified by the guideline developer on June 27, 2005.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions.

### DISCLAIMER

#### NGC DISCLAIMER

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Date Modified: 11/3/2008