A Phase 4 interventional study of Loceryl NL and Ciclopirox NL in Foot Dermatoses, sponsored by Galderma R&D. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-22.
Sponsored by Galderma R&D · Phase 4, Interventional, and Treatment
The main objective of this study is to compare subject's compliance and satisfaction for two modes of treatment of toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl NL) and Ciclopirox Nail Lacquer (Ciclopirox NL).
A total of 20 subjects are to be included in 1 site in Germany.
Methodology:
Subjects will receive the following treatments on the right or left toenails:
147 studies on the registry are indexed under Onychomycosis; 13 are open to participants now.
This study's enrollment of 20 is below the median of 56 across 134 interventional studies indexed under Onychomycosis.
Browse Onychomycosis studies →Galderma R&D is the lead sponsor of 280 studies on the registry; 9 are open to participants now.
Of its 59 completed or terminated interventional studies of FDA-regulated products, 55 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Amorolfine hydrochloride NL 5% to be applied once weekly for 12 weeks on all affected toenails of one foot
Drug: Loceryl 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, once weekly in the evening (at bed time) after filing down the affected toenails.
Also known as: Loceryl Nail Lacquer
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
Also known as: Ciclopirox Nail Lacquer
Percent of "in Label" Adherent Subjects
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)
Time frame: Week 12
Percent of Subjects Satisfied to Very Satisfied With Each Study Treatment at Week 12
Percent of subjects satisfied to very satisfied with both treatments (Loceryl nail lacquer and/or Ciclopirox nail lacquer) at week 12
Time frame: Week 12
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
| Milestone | Loceryl NL and Ciclopirox NL |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
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)
| percentage of participants | Loceryl NL | Ciclopirox NL |
|---|---|---|
| Percent of "in Label" Adherent Subjects | 85 | 60 |
Percent of subjects satisfied to very satisfied with both treatments (Loceryl nail lacquer and/or Ciclopirox nail lacquer) at week 12
| percentage of participants | Loceryl NL | Ciclopirox NL |
|---|---|---|
| Percent of Subjects Satisfied to Very Satisfied With Each Study Treatment at Week 12 | 60 | 60 |
Collected over During the study (12 weeks). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Loceryl NL + Ciclopirox NL | 0/20 (0%) | 0/20 (0%) | 3/20 (15%) |
| Event | Loceryl NL + Ciclopirox NL |
|---|---|
| NasopharyngitisInfections and infestations | 2/20 |
| NauseaGastrointestinal disorders | 1/20 |
| BronchiolitisInfections and infestations | 1/20 |
| HeadacheNervous system disorders | 1/20 |
| Age, Categorical(Participants) | Loceryl NL + Ciclopirox NL |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 18 |
| >=65 years | 2 |
| Age, Continuous(years) | Loceryl NL + Ciclopirox NL |
|---|---|
| Mean | 54.5 ± 8.7 |
| Sex: Female, Male(Participants) | Loceryl NL + Ciclopirox NL |
|---|---|
| Female | 10 |
| Male | 10 |
| Region of Enrollment(participants) | Loceryl NL + Ciclopirox NL |
|---|---|
| Germany | 20 |
Plan to share: No
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Galderma R&D