Foot Dermatoses
Conditions
Keywords
Onychomycosis
Brief summary
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).
Detailed description
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: * 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.
Interventions
DRUGLoceryl 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.
DRUGCiclopirox 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
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
Intra-individual study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject with clinically Distal and Lateral Subungual Onychomycosis (DLSO) due to dermatophytes and/or yeast (including Candida) on at least one toenail of each foot at screening visit, * Subject with less than 80% of the nail surface area with disease involvement and without matrix involvement, no dermatophytoma, streaks (spikes) or subungual hyperkeratosis \> 2mm, * Subjects with positive mycological results (direct microscopy and culture) for dermatophytes and/or yeasts (including Candida) at baseline, * Subjects with same number of affected toenails on both feet or no more than one additional affected toenail on one of the feet,
Exclusion criteria
* Subject with a surgical, medical condition or clinically important abnormal physical findings, which, in the judgement of the investigator, might interfere with interpretation of the objectives of the study (i.e. lack of autonomy), * Subjects with post-traumatic nail, lichen planus, eczema, psoriasis, or other abnormalities of the nail unit, which could affect/influence the subject's compliance of the investigational products, or mask the effects of treatment (cure), * Subjects with known immunodeficiency, radiation therapy, immune suppressive drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of in Label Adherent Subjects | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects Satisfied to Very Satisfied With Each Study Treatment at Week 12 | Week 12 | Percent of subjects satisfied to very satisfied with both treatments (Loceryl nail lacquer and/or Ciclopirox nail lacquer) at week 12 |
Countries
Germany
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| Loceryl NL + 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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Loceryl NL + Ciclopirox NL |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age, Continuous | 54.5 years STANDARD_DEVIATION 8.7 |
| Region of Enrollment Germany | 20 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 3 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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
Population: Intention To Treat popoulation (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Loceryl NL | Percent of in Label Adherent Subjects | 85 percentage of participants |
| Ciclopirox NL | Percent of in Label Adherent Subjects | 60 percentage of participants |
Secondary
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
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Loceryl NL | Percent of Subjects Satisfied to Very Satisfied With Each Study Treatment at Week 12 | 60 percentage of participants |
| Ciclopirox NL | Percent of Subjects Satisfied to Very Satisfied With Each Study Treatment at Week 12 | 60 percentage of participants |