|
Welcome
|
|
21 March 2013
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | news |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| The efficacy of a nail laquer in daily practice use, in patients with persistent onychomycosis who failed a previous topical treatment |
| ISRCTN | ISRCTN64177501 |
| DOI | 10.1186/ISRCTN64177501 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | The efficacy of a nail laquer in daily practice use, in patients with persistent onychomycosis who failed a previous topical treatment |
| Scientific title | Ciclopoli® 8% Nagellack administration in onychomycotic patients who failed previously topical treatment |
| Acronym | N/A |
| Serial number at source | PM0921 |
| 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. |
| Lay 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. What does the study involve? All participants that failed a treatment with amorolfine, received the same treatment with Ciclopoli® 8% Nagellack. Who can take part? Approximately 70 patients with persistent onychomycosis, after unsuccessful topical treatment with amorolfine, have been included. When does the study take place? The patients were recruited between June 2011 and July 2012. Where does the study take place? Ten dermatologists in Germany participated. What are the risks and the benefits to participants? 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. Who is funding the project? Polichem SA (Switzerland) Who is the main contact? Francesco Scarci francesco.scarci@polichem.com |
| Ethics approval | Ethics Committee of the Bavarian Landesarytekammer [Ethik-Kommission der Bayerischen Landesarytekammer], 21.04.2011, Ref number: 7/11049 |
| Study design | Observational study |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Onychomycosis |
| Participants - 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) |
| Participants - exclusion criteria | Onychomychotic patients with indication to oral treament |
| Anticipated start date | 01/06/2011 |
| Anticipated end date | 31/12/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 70 evaluable patients are needed |
| 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 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), |
| Primary outcome measure(s) | Negative conversion of direct microscopy examination (KOH) of the target nail after 6 months of treatment |
| Secondary outcome measure(s) |
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 |
| Sources of funding | Polichem SA (Switzerland) |
| Trial website | |
| Publications | |
| Contact name | Prof Wolfgang Vanscheidt |
| Address |
Facharzt für Dermatologie Phlebologie Allergologie
Paula-Modersohn-Platz 3 |
| City/town | Freiburg |
| Zip/Postcode | 79100 |
| Country | Germany |
| Sponsor | Polichem SA (Switzerland) |
| Address | Via Senago 42D |
| City/town | Lugano-Pazzallo |
| Zip/Postcode | CH - 6912 |
| Country | Switzerland |
| Sponsor website: | http://www.polichem.com |
| Date applied | 14/01/2013 |
| Last edited | 23/01/2013 |
| Date ISRCTN assigned | 23/01/2013 |
|
|
|
|
|
| © 2013 ISRCTN unless otherwise stated. | |
|
