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Derm News: 2007.8(5)

The impact of aggressive debridement used as an adjunct therapy with terbinafine on perceptions of patients undergoing treatment for toenail onychomycosis

Journal of Dermatological Treatment, Volume 18, Issue 1 2007, pages 46-52
Lori P. Potter; Susan D. Mathias; Monika Raut; Farid Kianifard; Adam Landsman; Amir Tavakkol
ABSTRACT

Objectives

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-tTM, 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, symptom bothersomeness, 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.


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The Derm News service provided by the Editorial Consultants of Skin Therapy Letter© and its founding editor Dr. Stuart Maddin.