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

ISRCTN	ISRCTN64177501
DOI	https://doi.org/10.1186/ISRCTN64177501
Secondary identifying numbers	PM0921

Submission date: 14/01/2013
Registration date: 23/01/2013
Last edited: 10/07/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Wolfgang Vanscheidt
Scientific

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

Study information

Study design	Observational study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Ciclopoli® 8% Nagellack administration in onychomycotic patients who failed previously topical treatment
Study objectives	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(s)	Ethics Committee of the Bavarian Landesarytekammer [Ethik-Kommission der Bayerischen Landesarytekammer], 21/04/2011, ref: 7/11049
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	8% ciclopirox lacquer Ciclopoli® 8% Nagellack
Primary outcome measure	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 study start date	01/06/2011
Completion date	31/12/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	70 evaluable patients are needed
Key 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)
Key exclusion criteria	Onychomychotic patients with indication to oral treament
Date of first enrolment	01/06/2011
Date of final enrolment	01/07/2012

Locations

Countries of recruitment

Germany

Study participating centre

Facharzt für Dermatologie Phlebologie Allergologie

Freiburg
79100
Germany

Sponsor information

Polichem SA (Switzerland)
Industry

Via Senago 42D
Lugano-Pazzallo
CH - 6912
Switzerland

Website	http://www.polichem.com
"ROR"	https://ror.org/05735qy63

Funders

Funder type

Industry

Polichem SA (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan