Condition category
Infections and Infestations
Date applied
14/01/2013
Date assigned
23/01/2013
Last edited
10/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Onychomycosis is a common fungal infection of the nail mostly caused by dermatophytic fungi. Two compounds, amorolfine and ciclopirox, are currently used in a lacquer base as treatment. The study assesses whether treatment with Ciclopoli 8% Nagellack is useful in those patients (about 40-50%) who did not see any improvements after amorolfine local treatment.

Who can participate?
Approximately 70 patients with persistent onychomycosis, after unsuccessful topical treatment with amorolfine, have been included.

What does the study involve?
All participants that failed a treatment with amorolfine, received the same treatment with Ciclopoli® 8% Nagellack.

What are the possible benefits and risks of participating?
The study could offer the chance of healing those patients previously treated without success with amorolfine, with a response rate similar to the oral treatment but with lower drug exposure.
As it is a topical administration, there are no risks.

Where is the study run from?
Ten dermatologists in Germany participated.

When is the study starting and how long is it expected to run for?
The patients were recruited between June 2011 and July 2012.

Who is funding the project?
Polichem SA (Switzerland).

Who is the main contact?
Francesco Scarci
francesco.scarci@polichem.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Wolfgang Vanscheidt

ORCID ID

Contact details

Facharzt für Dermatologie Phlebologie Allergologie
Paula-Modersohn-Platz 3
Freiburg
79100
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PM0921

Study information

Scientific title

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

Acronym

Study hypothesis

Onychomycosis is a fungal infection of the nail. It is the most common disease of the nails and constitutes about a half of all nail abnormalities. This condition may affect toenails or fingernails, but toenail infections are particularly common.

This observational study would highlight if a drug with an optimal nail penetration, such as the water-soluble 8% ciclopirox lacquer Ciclopoli® 8% Nagellack, is useful in the real life onychomycosis treatment, in those patients unable to convert to negative direct examination (KOH) after amorolfine local treatment as no controlled data on amorolfine negative conversion of KOH were available.

Ethics approval

Ethics Committee of the Bavarian Landesarytekammer [Ethik-Kommission der Bayerischen Landesarytekammer], 21/04/2011, ref: 7/11049

Study design

Observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Onychomycosis

Intervention

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 duration is 6 months. Ciclopoli® 8% Nagellack should be applied once/day on the affected nails. Nevertheless, it is recommended to treat all nails, even if they are not affected. Therefore the period that the patients underwent to the treatment was 6 months with visits at 3 different timepoints (recruitment, 3 months and 6 months),

Intervention type

Drug

Phase

Not Applicable

Drug names

8% ciclopirox lacquer Ciclopoli® 8% Nagellack

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/06/2011

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70 evaluable patients are needed

Participant exclusion criteria

Onychomychotic patients with indication to oral treament

Recruitment start date

01/06/2011

Recruitment end date

01/07/2012

Locations

Countries of recruitment

Germany

Trial participating centre

Facharzt für Dermatologie Phlebologie Allergologie
Freiburg
79100
Germany

Sponsor information

Organisation

Polichem SA (Switzerland)

Sponsor details

Via Senago 42D
Lugano-Pazzallo
CH - 6912
Switzerland

Sponsor type

Industry

Website

http://www.polichem.com

Funders

Funder type

Industry

Funder name

Polichem SA (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes