Trial Outcomes & Findings for Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail Lacquer (NCT NCT02679911)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

Week 12

Results posted on

2021-03-22

Participant Flow

Subjects at screening had a mycological sampling of affected great toenail and for inclusion subjects shoud have both direct microscopy and culture results positive at Baseline

Participant milestones

Participant milestones
Measure	Loceryl NL and Ciclopirox NL Loceryl Nail Lacquer to be applied once weekly for 12 weeks over the entire toenail plate of all affected toenails in the evening (at bed time) after filing down the affected toenails. Ciclopirox NL to be applied once daily for 12 weeks over the entire toenail plate of all affected toenails and surrounding skin in the evening (at bed time) after removing the free toenail edge and diseased toenails if needed
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail Lacquer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Loceryl NL + Ciclopirox NL n=20 Participants Loceryl Nail Lacquer to be applied once weekly for 12 weeks over the entire toenail plate of all affected toenails in the evening (at bed time) after filing down the affected toenails. Ciclopirox NL to be applied once daily for 12 weeks over the entire toenail plate of all affected toenails and surrounding skin in the evening (at bed time) after removing the free toenail edge and diseased toenails if needed
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	54.5 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment Germany	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Intention To Treat popoulation (ITT)

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)

Outcome measures

Outcome measures
Measure	Loceryl NL n=20 Participants Loceryl Nail Lacquer to be applied once weekly for 12 weeks over the entire toenail plate of all affected toenails in the evening (at bed time) after filing down the affected toenails.	Ciclopirox NL n=20 Participants Ciclopirox NL to be applied once daily for 12 weeks over the entire toenail plate of all affected toenails and surrounding skin in the evening (at bed time) after removing the free toenail edge and diseased toenails if needed
Percent of "in Label" Adherent Subjects	85 percentage of participants	60 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: ITT population

Percent of subjects satisfied to very satisfied with both treatments (Loceryl nail lacquer and/or Ciclopirox nail lacquer) at week 12

Outcome measures

Outcome measures
Measure	Loceryl NL n=20 Participants Loceryl Nail Lacquer to be applied once weekly for 12 weeks over the entire toenail plate of all affected toenails in the evening (at bed time) after filing down the affected toenails.	Ciclopirox NL n=20 Participants Ciclopirox NL to be applied once daily for 12 weeks over the entire toenail plate of all affected toenails and surrounding skin in the evening (at bed time) after removing the free toenail edge and diseased toenails if needed
Percent of Subjects Satisfied to Very Satisfied With Each Study Treatment at Week 12	60 percentage of participants	60 percentage of participants

Adverse Events

Loceryl NL + Ciclopirox NL

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Loceryl NL + Ciclopirox NL n=20 participants at risk Loceryl Nail Lacquer to be applied once weekly for 12 weeks over the entire toenail plate of all affected toenails in the evening (at bed time) after filing down the affected toenails. Ciclopirox NL to be applied once daily for 12 weeks over the entire toenail plate of all affected toenails and surrounding skin in the evening (at bed time) after removing the free toenail edge and diseased toenails if needed Note: Adverse Events are not available for each intervention.
Gastrointestinal disorders Nausea	5.0% 1/20 • Number of events 1 • During the study (12 weeks)
Infections and infestations Bronchiolitis	5.0% 1/20 • Number of events 1 • During the study (12 weeks)
Infections and infestations Nasopharyngitis	10.0% 2/20 • Number of events 2 • During the study (12 weeks)
Nervous system disorders Headache	5.0% 1/20 • Number of events 1 • During the study (12 weeks)

Additional Information

Farzaneh SIDOU Clinical Project Manager

Galderma

Phone: 0493957051

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place