The efficacy of a nail laquer in daily practice use, in patients with persistent onychomycosis who failed a previous topical treatment

Ciclopoli® 8% Nagellack administration in onychomycotic patients who failed previously topical treatment

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN64177501

Enrollment

Registered

2013-01-23

Start date

2011-06-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Onychomycosis Infections and Infestations Onychomycosis

Interventions

Observational study over a period of 24 weeks in patients unsuccesfully treated topically with a different antimycotic nail laquer. According to the scientific information, the usual treatment durati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with the following characteristics should be considered for inclusion into the study: 1. Diagnosis: distolateral or subungual mild to moderate onychomycosis (ICD 10, Ziffer B 35.1) 2. Patients of both gender, aged above 18 years old 3. Indication for local treatment of Onychomycosis with Ciclopoli® 8% Nagellack 4. Laboratory finding positive for fungi (KOH examination) 5. Affected area of minimum 10% of at least one toenail or one fingernail 6. Unsuccessful topical amorolfine treatment lasted at least 6 months and concluded no later than one month before inclusion 7. No concomitant oral treatment for onychomycosis 8. Signed informed consent form (ICF)

Exclusion criteria

Exclusion criteria: Onychomychotic patients with indication to oral treament

Design outcomes

Primary

Measure	Time frame
Negative conversion of direct microscopy examination (KOH) of the target nail after 6 months of treatment	—

Secondary

Measure	Time frame
1. Clinical improvement of the target nail (change of affected area compared to baseline assessed by Physician) after 3 and 6 months of treatment 2. Clinical improvement of the other affected nails (change of affected area compared to baseline assessed by Physician) after 3 and 6 months of treatment 3. Clinical evaluation of the number of affected nails at baseline and at the end of 6-month therapy 4. Patient's treatment satisfaction assessed by Clinical Global Impression-scale (CGI), after 3 and 6 months 5. Investigator's treatment satisfaction assessed by Clinical Global Impressionscale (CGI) with the previous amorolfine treatment at Screening 6. Investigator's treatment satisfaction assessed by Clinical Global Impressionscale (CGI) after 6 months 7. The evaluation of safety	—

Measure

Time frame

1. Clinical improvement of the target nail (change of affected area compared to baseline assessed by Physician) after 3 and 6 months of treatment 2. Clinical improvement of the other affected nails (change of affected area compared to baseline assessed by Physician) after 3 and 6 months of treatment 3. Clinical evaluation of the number of affected nails at baseline and at the end of 6-month therapy 4. Patient's treatment satisfaction assessed by Clinical Global Impression-scale (CGI), after 3 and 6 months 5. Investigator's treatment satisfaction assessed by Clinical Global Impressionscale (CGI) with the previous amorolfine treatment at Screening 6. Investigator's treatment satisfaction assessed by Clinical Global Impressionscale (CGI) after 6 months 7. The evaluation of safety

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Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026