The impact of aggressive debridement used as an adjunct therapy with terbinafine on perceptions of patients undergoing treatment for toenail onychomycosis.
OBJECTIVE
To determine whether adding aggressive debridement to oral terbinafine for treating toenail onychomycosis impacts patient-reported outcomes (PROs).


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.
Potter
Lori P
LP
Ovation Research Group. San Francisco, CA, USA.
Mathias
Susan D
SD
Raut
Monika
M
Kianifard
Farid
F
Landsman
Adam
A
Tavakkol
Amir
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000627:therapeutic use*; D001900:Boston; D003646:Debridement / Q000379:methods; D005260:Female; D005533:Foot Dermatoses / Q000188:drug therapy* / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D009262:Nails; D009281:Naphthalenes / Q000627:therapeutic use*; D014009:Onychomycosis / Q000188:drug therapy* / Q000601:surgery; D011446:Prospective Studies; D012495:San Francisco; D011795:Surveys and Questionnaires; D000077291:Terbinafine; D016896:Treatment Outcome
D000935:Antifungal Agents; D009281:Naphthalenes; D000077291:Terbinafine