Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail Lacquer (LOOP)
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|ClinicalTrials.gov Identifier: NCT02679911|
Recruitment Status : Completed
First Posted : February 11, 2016
Results First Posted : October 3, 2018
Last Update Posted : October 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Foot Dermatoses||Drug: Loceryl NL Drug: Ciclopirox NL||Phase 4|
A total of 20 subjects are to be included in 1 site in Germany.
Subjects will receive the following treatments on the right or left toenails:
- Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails of one foot.
- Ciclopirox Nail Lacquer to be applied once daily for 12 weeks on all affected toenails of the opposite foot.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Intra-individual study|
|Official Title:||Subject Adherence and Satisfaction for Treatment of Onychomycosis With Loceryl Nail Lacquer 5% Versus Ciclopirox Nail Lacquer|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Loceryl NL
Amorolfine hydrochloride NL 5% to be applied once weekly for 12 weeks on all affected toenails of one foot
Drug: Loceryl NL
Topical over the entire toenail plate of all affected toenails, once weekly in the evening (at bed time) after filing down the affected toenails.
Other Name: Loceryl Nail Lacquer
Active Comparator: Ciclopirox NL
Ciclopirox NL 8% to be applied once daily for 12 weeks on all affected toenails of the opposite foot
Drug: Ciclopirox NL
Topical over the entire toenail plate of all affected toenails and surrounding skin, once daily in the evening (at bed time) after removing the free toenail edge and diseased toenails if needed
Other Name: Ciclopirox Nail Lacquer
- % "in Label" Adherent Subjects [ Time Frame: Week 12 ]Percent of subjects having applied both treatments as instructed per labeling (once a week for Loceryl NL and once a day for Ciclopirox after 2 weeks)
- % Subjects Satisfied to Very Satisfied With Each Study Treatment at Week 12 [ Time Frame: Week 12 ]Percent of subjects satisfied to very satisfied with both treatments (Loceryl nail lacquer and/or Ciclopirox nail lacquer) at week 12
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679911
|Principal Investigator:||Prof. Schaller||Universitäts-Hautklinik|