A multicenter, randomized, open-label, controlled study comparing the efficacy, safety and cost-effectiveness of a sequential therapy with RV4104A ointment, ciclopiroxolamine cream and ciclopirox film-forming solution with amorolfine nail lacquer alone in dermatophytic onychomycosis.
BACKGROUND
The efficacy of topical antifungals is controversial.


OBJECTIVE
To compare the efficacy and safety of a sequential(SEQ) treatment with chemical nail avulsion and topical antifungals to amorolfine nail lacquer in dermatophytic onychomycosis.


METHODS
This was a randomized,parallel-group, controlled study comparing a 36-week SEQ treatment with chemical nail avulsion with RV4104A ointment(class I medical device containing 40% urea) followed by ciclopirox cream for 8 weeks and ciclopirox nail lacquer for 25 weeks (SEQ group) to amorolfine nail lacquer for 36 weeks (AMO group). Patients had to have a big toenail onychomycosis,sparing the matrix. The primary efficacy criterion was complete cure at week 48. A cost-effectiveness analysis was performed.


RESULTS
A total of 142 patients were randomized. The complete cure rate at week 48 was significantly higher in the SEQ group than in the AMO group (36.6 vs. 12.7%, p = 0.001). Clinical cure at week 48 was observed in 53.5% of patients in the SEQ group versus 17% in the AMO group (p < 0.01). The cost of cure per patient was 50% lower with SEQ treatment (EUR 33) compared with amorolfine(EUR 76).


CONCLUSIONS
A treatment of onychomycosis comprising chemical avulsion of the pathological nail, ciclopirox cream and nail lacquer is significantly more effective than amorolfine nail lacquer.
C
C
Paul
D
D
Coustou
M
M
Lahfa
C
C
Bulai-Livideanu
N
N
Doss
I
I
Mokthar
H
H
Turki
R
R
Nouira
B
B
Fazaa
A
A
Ben Osman
O
O
Zourabichvili
C
C
Cazeau
H
H
Coubetergues
S
S
Picot
A L
AL
Bienvenu
J J
JJ
Voisard
D000293:Adolescent; D000328:Adult; D000368:Aged; D000935:Antifungal Agents; D000077768:Ciclopirox; D003362:Cost-Benefit Analysis; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005533:Foot Dermatoses / Q000188:drug therapy* / Q000191:economics*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage*; D009824:Ointments / Q000008:administration & dosage; D014009:Onychomycosis / Q000188:drug therapy* / Q000191:economics*; D011728:Pyridones / Q000008:administration & dosage* / Q000627:therapeutic use; D012189:Retrospective Studies; D063465:Skin Cream / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D000935:Antifungal Agents; D004338:Drug Combinations; D009025:Morpholines; D009824:Ointments; D011728:Pyridones; D000077768:Ciclopirox; C038974:amorolfine