Foot DermatosesPhase 4LOOPNCT02679911
Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail Lacquer
A Phase 4 study testing Loceryl NL and Ciclopirox NL in people with Foot Dermatoses, run by Galderma R&D at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Dermatoses
- What is being tested?
- Loceryl NL and Ciclopirox NL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2015to Jun 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subject Adherence and Satisfaction for Treatment of Onychomycosis With Loceryl Nail Lacquer 5% Versus Ciclopirox Nail Lacquer
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).
Read the 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.
- Conditions
- Foot Dermatoses
- Being tested
- Loceryl NL, Ciclopirox NL
- Keywords
- Onychomycosis
- Medical subject headings
- Foot Dermatoses, Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loceryl NLDrug
Also called Loceryl Nail Lacquer
Topical over the entire toenail plate of all affected toenails, once weekly in the evening (at bed time) after filing down the affected toenails.
Ciclopirox NLDrug
Also called Ciclopirox 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
| Study group | Role | What they receive |
|---|---|---|
| Loceryl NL | Experimental | Amorolfine hydrochloride NL 5% to be applied once weekly for 12 weeks on all affected toenails of one foot Receives: Drug: Loceryl NL |
| Ciclopirox NL | Active comparator | Ciclopirox NL 8% to be applied once daily for 12 weeks on all affected toenails of the opposite foot Receives: Drug: Ciclopirox NL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Week 12
Secondary outcomes (1)
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
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Foot DermatosesStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intra-individual study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Schaller, Principal investigator, Universitäts-Hautklinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679911
- Sponsor's protocol ID
- RD.03.SPR105082
- Other IDs
- 2015-001237-24, 2015
- Acronym
- LOOP
- Status last verified
- Feb 2018
- First submitted
- 20 Nov 2015
- Last updated
- 22 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subject Adherence and Satisfaction for Treatment of Onychomycosis With Loceryl Nail Lacquer 5% Versus Ciclopirox Nail Lacquer
- ClinicalTrials.gov ID
- NCT02679911
- Acronym / sponsor ID
- LOOP / RD.03.SPR105082
- Conditions
- Foot Dermatoses
- Keywords
- Onychomycosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 11 Feb 2016 (estimated)
- Results
- Posted 3 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Intra-individual study
| Arm | Type | Receives |
|---|---|---|
| Loceryl NL | Experimental | Drug: Loceryl NLAmorolfine hydrochloride NL 5% to be applied once weekly for 12 weeks on all affected toenails of one foot |
| Ciclopirox NL | Active comparator | Drug: Ciclopirox NLCiclopirox NL 8% to be applied once daily for 12 weeks on all affected toenails of the opposite foot |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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,
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loceryl NLAlso: Loceryl Nail LacquerTopical over the entire toenail plate of all affected toenails, once weekly in the evening (at bed time) after filing down the affected toenails. | Drug | Loceryl NL |
| Ciclopirox NLAlso: Ciclopirox Nail LacquerTopical 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 | Drug | Ciclopirox NL |
Primary outcome
Percent of "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)
1 secondary outcome
Percent of Subjects Satisfied to Very Satisfied With Each Study Treatment at Week 12
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Schaller principal investigator
Universitäts-Hautklinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Loceryl NL and Ciclopirox NL in people with Foot Dermatoses, run by Galderma R&D at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of "in Label" Adherent Subjects (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.