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

Not Applicable

Completed

• Conditions: Onychomycosis; Infections and Infestations

• Registration Number: ISRCTN64177501
• Lead Sponsor: Polichem SA (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-23
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

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

Onychomychotic patients with indication to oral treament

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
egative conversion of direct microscopy examination (KOH) of the target nail after 6 months of treatment

Secondary Outcome Measures

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