INDICATIONS AND USAGE
(To understand fully the indication for this
product, please read the entire INDICATIONS AND USAGE section of the
labeling.)
Ciclopirox topical solution, 8% (nail lacquer), as a component of a
comprehensive management program, is indicated as topical treatment in
immunocompetent patients with mild to moderate onychomycosis of fingernails and
toenails without lunula involvement, due to Trichophyton
rubrum. The
comprehensive management program includes removal of the unattached, infected
nails as frequently as monthly, by a health care professional who has special
competence in the diagnosis and treatment of nail disorders, including minor
nail procedures.
No studies have been conducted to determine whether ciclopirox might reduce
the effectiveness of systemic antifungal agents for onychomycosis. Therefore,
the concomitant use of 8% ciclopirox topical solution and systemic antifungal
agents for onychomycosis, is not recommended.
Ciclopirox topical solution, 8% (nail lacquer), should be used only under
medical supervision as described above.
The effectiveness and safety of ciclopirox topical solution, 8% (nail
lacquer), in the following populations has not been studied. The clinical trials
with use of ciclopirox topical solution, 8% (nail lacquer), excluded patients
who: were pregnant or nursing, planned to become pregnant, had a history of
immunosuppression (e.g., extensive, persistent, or unusual distribution of
dermatomycoses, extensive seborrheic dermatitis, recent or recurring herpes
zoster, or persistent herpes simplex), were HIV seropositive, received organ
transplant, required medication to control epilepsy, were insulin dependent
diabetics or had diabetic neuropathy. Patients with severe plantar (moccasin)
tinea pedis were also excluded.
The safety and efficacy of using ciclopirox topical solution, 8% (nail
lacquer), daily for greater than 48 weeks have not been established.
Clinical Trials DataThe results of use of ciclopirox topical solution, 8% (nail
lacquer), in treatment of onychomycosis of the toenail without lunula
involvement were obtained from two double-blind, placebo-controlled studies
conducted in the US. In these studies, patients with onychomycosis of the great
toenails without lunula involvement were treated with ciclopirox topical
solution, 8% (nail lacquer) in conjunction with monthly removal of the
unattached, infected toenail by the investigator. Ciclopirox topical solution,
8% (nail lacquer), was applied for 48 weeks. At baseline, patients had 20 to 65%
involvement of the target great toenail plate. Statistical significance was
demonstrated in one of two studies for the endpoint complete cure (clear nail
and negative mycology), and in two studies for the endpoint almost clear (
10% nail involvement and negative mycology) at the end of study. These results
are presented below.
At Week 48 (plus Last Observation Carried Forward) for the Intent-to-Treat (ITT) Population
Study 312
Study 313
Active
Vehicle
Active
Vehicle
CompleteCure*
6/110 (5.5%)
1/109 (0.9%)
10/118 (8.5%)
0/117 (0%)
AlmostClear**
7/107 (6.5%)
1/108 (0.9%)
14/116 (12%)
1/115 (0.9%)
NegativeMycologyAlone***
30/105 (29%)
12/106 (11%)
41/115 (36%)
10/114 (9%)
* Clear nail and negative mycology**
10% nail involvement and negative mycology*** Negative KOH and negative culture
The summary of reported patient outcomes for the ITT population at 12 weeks
following the end of treatment are presented below. Note that post-treatment
efficacy assessments were scheduled only for patients who achieved a complete
cure.
Post-Treatment Week 12 Data for Patients Who Achieved Complete Cure at Week 48
Study 312
Study 313
Active
Vehicle
Active
Vehicle
Number of Treated Patients
112
111
119
118
Complete Cure at Week 48
6
1
10
0
Post-Treatment Week 12 Outcomes:
Patients Missing All Week 12 Assessments
2
0
2
0
Patients with Week 12 Assessments
4
1
8
0
Complete Cure
3
1
4
0
Almost Clear
2*
1
1*
0
Negative Mycology
3
1
5
0
* Four patients (from studies 312 and 313) who were completely cured did not have post-treatment
Week 12 planimetry data.