Foot DermatosesPhase 4OPENNCT02705664
Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus a Two-course Treatment With Urea 40% Ointment and Bifonazole Cream 1%
A Phase 4 study testing Loceryl Nail Lacquer, Urea Ointment and Bifonazole Cream in people with Foot Dermatoses, run by Galderma R&D at 1 site in Iceland.
Trial summary
The main objective of this study is to compare subject adherence and satisfaction for two modes of treatment toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl NL) and a Fungal Nail Treatment Set containing Urea 40% ointment (Urea) and Bifonazole cream 1% (Bifonazole). 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 Nail Lacquer, Urea Ointment and Bifonazole Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteIceland
- Study dates
- Jan 2016to Sep 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Subjects with clinically Distal and Lateral Subungual Onychomycosis (DLSO) due to dermatophytes and/or yeast (including Candida) on at least one great toenail of each foot at screening visit,
- Subjects with less than 50% of the toenail surface area from the Distal edge with disease involvement and without matrix involvement, no dermatophytoma, streaks (spikes) or subungual hyperkeratosis > 2mm,
- Subjects should have the same number of affected toenails on both feet or no more than one additional affected toenail on one of the feet,
- Subjects with positive mycological results (direct microscopy and culture) of the most affected toenail (or great toenail) for dermatophytes or yeast (including Candida) at Baseline
Who cannot join
- Subjects with matrix involvement on the great toenails,
- Subjects with a surgical, medical condition or clinically important abnormal physical findings which might interfere with the interpretation of the objectives of the study
- Post-traumatic toenail, lichen planus, eczema, psoriasis, or other abnormalities of the nail unit, which could affect/influence the subject's compliance with the investigational products or mask the effects of treatment (cure),
- 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 a Fungal Nail Treatment Set Containing Urea 40% Ointment and Bifonazole Cream 1%
The main objective of this study is to compare subject adherence and satisfaction for two modes of treatment toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl NL) and a Fungal Nail Treatment Set containing Urea 40% ointment (Urea) and Bifonazole cream 1% (Bifonazole).
Read the detailed description
A total of 20 subjects are to be included in 1 site in Iceland
Methodology:
Subjects will receive following treatments on the right or left toenails:
- Loceryl Nail Lacquer (Loceryl NL) to be applied once weekly for 7 weeks on all affected toenails of one foot (including great toenail)
- Fungal Nail Treatment Set to be used on all affected toenails (including great toenail) of the opposite foot in two phases:
- Phase I: Urea ointment (Urea) to be applied once a day under occlusion for 2-3 weeks depending on the achievement of optimal diseased toenail plates removal
- Phase II: Bifonazole cream to (Bifonazole) be applied for 4 weeks on affected toenails (after the maximum 3-week treatment period with Urea ointment)
- Conditions
- Foot Dermatoses
- Being tested
- Loceryl Nail Lacquer, Urea Ointment, Bifonazole Cream
- 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 Nail LacquerDrug
Also called Loceryl NL
Topical over entire toenail plates of affected toenails once weekly in the evening (at bed time) after having filled down affected toenails to gently remove as much as affected nails and having cleaned toenails surfaces with the provided cleansing swab
Urea OintmentDrug
Also called Urea
Topical over the infected part of the toenails only once daily under occlusion in the evening (at bed time) after having soaked toenails in warm water and having removed the soften infected toenail plates and dried the toenails
Bifonazole CreamDrug
Also called Bifonazole
Topical, to be rubbed sparingly over the affected toenail skin (nail bed) once daily in the evening (at bed time) after having cleaned and dried thoroughly toenails
| Study group | Role | What they receive |
|---|---|---|
| Loceryl NL | Experimental | Amorolfine hydrochloride NL 5% to be applied once weekly for 7 weeks on all affected toenails of one foot Receives: Drug: Loceryl Nail Lacquer |
| Urea Ointment + Bifonazole Cream | Active comparator | On the opposite foot:
1. Urea 40% ointment to be applied once a day under occlusion for 2-3 weeks depending on the achievement of optimal diseased toenail plates removal)
2. Bifonazole 1% cream to be applied for 4 weeks on affected toenails (after the maximum 3-week treatment period with Urea ointment) Receives: Drug: Urea Ointment; Drug: Bifonazole Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
% adherent subjects with applications
Percent of subjects having applied both study treatments as instructed (once a week for Loceryl NL, once a day for urea and once a day for Bifonazole)
Measured: Week 7
% adherent subjects with nail preparation
Percent of subjects having prepared affected toenails as instructed for each product before applications:
- For Loceryl: File down the affected toenails as required and clean toenails surface with the cleansing swab
- For Urea: Soak toenails in warm water and remove soften infected toenails plates
- For Bifonazole: Clean and dry thoroughly affected toenails
Measured: Week 7
% Subjects satisfied to very satisfied with each study treatment at week 7
Percent of subjects satisfied to very satisfied with each study treatment at week 7
Measured: Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Sigurgeirsson, Principal investigator, Cutis Ehf (Dermatology Center)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705664
- Sponsor's protocol ID
- RD.03.SPR.105078
- Acronym
- OPEN
- Status last verified
- Sep 2016
- First submitted
- 7 Mar 2016
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 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 a Fungal Nail Treatment Set Containing Urea 40% Ointment and Bifonazole Cream 1%
- ClinicalTrials.gov ID
- NCT02705664
- Acronym / sponsor ID
- OPEN / RD.03.SPR.105078
- Conditions
- Foot Dermatoses
- Keywords
- Onychomycosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 10 Mar 2016 (estimated)
- Results
- Not posted in the source record
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 adherence and satisfaction for two modes of treatment toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl NL) and a Fungal Nail Treatment Set containing Urea 40% ointment (Urea) and Bifonazole cream 1% (Bifonazole).
Detailed description
A total of 20 subjects are to be included in 1 site in Iceland
Methodology:
Subjects will receive following treatments on the right or left toenails:
- Loceryl Nail Lacquer (Loceryl NL) to be applied once weekly for 7 weeks on all affected toenails of one foot (including great toenail)
- Fungal Nail Treatment Set to be used on all affected toenails (including great toenail) of the opposite foot in two phases:
- Phase I: Urea ointment (Urea) to be applied once a day under occlusion for 2-3 weeks depending on the achievement of optimal diseased toenail plates removal
- Phase II: Bifonazole cream to (Bifonazole) be applied for 4 weeks on affected toenails (after the maximum 3-week treatment period with Urea ointment)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loceryl NL | Experimental | Drug: Loceryl Nail LacquerAmorolfine hydrochloride NL 5% to be applied once weekly for 7 weeks on all affected toenails of one foot |
| Urea Ointment + Bifonazole Cream | Active comparator | Drug: Urea Ointment, Drug: Bifonazole CreamOn the opposite foot: 1. Urea 40% ointment to be applied once a day under occlusion for 2-3 weeks depending on the achievement of optimal diseased toenail plates removal) 2. Bifonazole 1% cream to be applied for 4 weeks on affected toenails (after the maximum 3-week treatment period with Urea ointment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with clinically Distal and Lateral Subungual Onychomycosis (DLSO) due to dermatophytes and/or yeast (including Candida) on at least one great toenail of each foot at screening visit,
- Subjects with less than 50% of the toenail surface area from the Distal edge with disease involvement and without matrix involvement, no dermatophytoma, streaks (spikes) or subungual hyperkeratosis > 2mm,
- Subjects should have the same number of affected toenails on both feet or no more than one additional affected toenail on one of the feet,
- Subjects with positive mycological results (direct microscopy and culture) of the most affected toenail (or great toenail) for dermatophytes or yeast (including Candida) at Baseline
Key exclusion criteria (4 listed)
- Subjects with matrix involvement on the great toenails,
- Subjects with a surgical, medical condition or clinically important abnormal physical findings which might interfere with the interpretation of the objectives of the study
- Post-traumatic toenail, lichen planus, eczema, psoriasis, or other abnormalities of the nail unit, which could affect/influence the subject's compliance with the investigational products or mask the effects of treatment (cure),
- 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 Nail LacquerAlso: Loceryl NLTopical over entire toenail plates of affected toenails once weekly in the evening (at bed time) after having filled down affected toenails to gently remove as much as affected nails and having cleaned toenails surfaces with the provided cleansing swab | Drug | Loceryl NL |
| Urea OintmentAlso: UreaTopical over the infected part of the toenails only once daily under occlusion in the evening (at bed time) after having soaked toenails in warm water and having removed the soften infected toenail plates and dried the toenails | Drug | Urea Ointment + Bifonazole Cream |
| Bifonazole CreamAlso: BifonazoleTopical, to be rubbed sparingly over the affected toenail skin (nail bed) once daily in the evening (at bed time) after having cleaned and dried thoroughly toenails | Drug | Urea Ointment + Bifonazole Cream |
Primary outcome
% adherent subjects with applications
Time frame: Week 7
Percent of subjects having applied both study treatments as instructed (once a week for Loceryl NL, once a day for urea and once a day for Bifonazole)
% adherent subjects with nail preparation
Time frame: Week 7
Percent of subjects having prepared affected toenails as instructed for each product before applications: * For Loceryl: File down the affected toenails as required and clean toenails surface with the cleansing swab * For Urea: Soak toenails in warm water and remove soften infected toenails plates * For Bifonazole: Clean and dry thoroughly affected toenails
% Subjects satisfied to very satisfied with each study treatment at week 7
Time frame: Week 7
Percent of subjects satisfied to very satisfied with each study treatment at week 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
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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.
Dr Sigurgeirsson principal investigator
Cutis Ehf (Dermatology Center)
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 Nail Lacquer, Urea Ointment and Bifonazole Cream in people with Foot Dermatoses, run by Galderma R&D at 1 site in Iceland.
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 4 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 17 Feb 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 Iceland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
% adherent subjects with applications (time frame: Week 7). The study lists 3 primary outcomes in all. 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 17 Feb 2021.