Source: DGNews  |  Posted 4 years ago

By Chris Berrie

VIENNA, AUSTRIA -- May 20, 2007 -- The new mini-tablet formulation of the antifungal agent terbinafine is both safe and effective for treatment of children with tinea capitis (ringworm), researchers reported here at the 16[^]th[] European Academy of Dermatology and Venereology Congress (EADV).

In addition, the terbinafine mini tablet shows superior activity to griseofulvin oral suspension against Trichophyton tonsurans, a dermatophyte commonly associated with tinea capitis, said Boni Elewski, MD, professor of dermatology and director of clinical research, department of dermatology, University of Alabama, Birmingham, Alabama, United States.

Dr. Elewski presented this prospectively planned analysis of the pooled populations from 2 international, multicentre, randomised, investigator-blinded, controlled trials in an oral session on May 18[^]th[].

Tinea capitis is an infection that is caused by dermatophytes of the genera Trichophyton and Microsporum, and its prevalence is increasing in several specific geographic areas. While systemic application of the antifungal agent griseofulvin has been developed as the gold standard for treatment of tinea capitis, in recent years treatment failures with this approved agent have become more common.

Thus, the aim of the present analysis was to combine the data from 2 identical trials that were conducted in children as comparisons of the efficacy and safety between the mini-tablet formulation of terbinafine and the oral suspension of griseofulvin.

The 2 studies under analysis recruited children aged 4 to 12 years with clinically diagnosed tinea capitis that was confirmed by potassium hydroxide microscopy. The original randomisation design provides for 1,040 children who were treated with terbinafine 5 to 8 mg/kg/day (male, 63.9%) and 509 treated with griseofulvin 10 to 20 mg/kg/day (male, 58.5%). Mean ages in the 2 groups were 6.9 years and 6.8 years, respectively.

Patient demographics and disease characteristics across these 2 treatment groups were not significantly different in terms of mean total sign and symptom scores (TSSS) as well as mean infection durations and diffuse and localised areas of involvement.

The 2 treatment groups were also similar in terms of presence of dermophyte species, which mainly including T. tonsurans (48.8% vs 50.5%, respectively), T. violaceum (15.4% vs 16.1%), and Microsporum canis (14.6% vs 16.1%), with 18.0% versus 14.7% testing negative.

Efficacy measures were calculated on the basis of the modified intention-to-treat (mITT) populations to obtain the primary efficacy measure of the complete cure rates (as mycological plus clinical) at end of the study. Secondary efficacy variables were the individual end-of-study mycological and clinical cure rates.

Scoring of signs and symptoms was done using a 4-point scale from "absent" to "severe" for erythema, desquamations/ scaling, and papules/pustules.

For the efficacy results, at end of study (week 10), the complete cure rate was significantly higher in the terbinafine group as compared with the griseofulvin group (45.1% vs 39.2%; []P[] =.024), as also seen for the higher mycological cure rates (61.5% vs 55.5%; []P[] =.029). Although the clinical cure rates were also higher for terbinafine, these did not reach significance (63.0% vs 58.8%; []P[] =.10).

The researchers also determined the impact of some of the dermatophyte species on the treatment effects. While no differences were seen between the 2 antifungals for T. violaceum, terbinafine showed superior cure rates to griseofulvin for T. tonsurans, while this was reversed for M. canis.

Although there was a wide range of adverse events reported by 50% of patients in each antifungal group, these were all mild or moderate. Those attributed to a study drug also fell evenly across the 2 treatment groups, at 9.2% for terbinafine and 8.3% for griseofulvin, with no drug-related serious adverse events or deaths.

Overall, pooled analysis of these 2 trials has provided the largest paediatric trials dataset for the comparison of these 2 antifungals to date, according to the researchers. In doing so, these data indicate that the terbinafine mini tablets are efficacious and well tolerated in children with tinea capitis.

Furthermore, terbinafine is seen to represent an important alternative for the treatment of tinea capitis, particularly with reference to the dermatophyte species selectivity seen in this analysis.

This study was sponsored by Novartis Pharmaceuticals.

[[]Presentation title: Efficacy and Safety of Terbinafine Mini Tablets Versus Griseofulvin Oral Suspension in Children With Tinea Capitis: Results of Two Randomised, Investigator-Blinded, Multicentre, International, Controlled Trials. Abstract P417[]]