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
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 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 trial start date
01/06/2011
Overall trial end date
31/12/2013
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list