Foot DermatosesPhase 4COOLNCT02321098
Antifungal Activity of Loceryl Nail Lacquer in Combination With a Cosmetic Varnish
A Phase 4 study testing Loceryl NL + Cosmetic varnish, Loceryl NL 12 weeks and Loceryl NL 15 months in people with Foot Dermatoses, run by Galderma R&D at 1 site in Iceland.
Trial summary
The main objective is to compare efficacy, in terms of antifungal activity of Loceryl Nail Lacquer associated with a Cosmetic Varnish and Loceryl Nail Lacquer alone, in the treatment of mild to moderate toenail Distal Subungual Onychomycosis. 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 + Cosmetic varnish, Loceryl NL 12 weeks and Loceryl NL 15 months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIceland
- Study dates
- Feb 2014to Jan 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
- Subjects with a mild to moderate Distal Subungual Onychomycosis (DSO) on at least 1 great toenail chosen as a Target nail
- Subjects must have maximum of 50% of nail distal edge involved
- Subjects with positive mycological results (direct microscopy and culture) of the Target nail for dermatophytes or Yeast (including Candida) at Screening
Who cannot join
- Subjects with clinically important abnormal physical findings at the Screening/Baseline visit
- Subjects with Lichen planus, eczema, psoriasis, or other abnormalities of the nail unit
- Subjects with known immunodeficiencies, radiation therapy, immune suppressive drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Antifungal Activity of Loceryl Nail Lacquer 5% When Used Concomitantly With a Cosmetic Nail Varnish Compared to a Loceryl Nail Lacquer (NL) 5% Alone in Treatment of Toenail Distal Subungual Onychomycosis
The main objective is to compare efficacy, in terms of antifungal activity of Loceryl Nail Lacquer associated with a Cosmetic Varnish and Loceryl Nail Lacquer alone, in the treatment of mild to moderate toenail Distal Subungual Onychomycosis.
The second objective of this study will be photographic follow-up of clinical improvement and cure after the initial treatment period of 12 weeks, for 15 additional months.
Read the detailed description
Study center:
A total of 50 subjects were to be included in 1 site in Iceland.
Methodology:
- Group Loceryl Nail Lacquer+ Cosmetic Varnish:
- Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails,
- Cosmetic varnish to be applied once weekly for 12 weeks on all affected toenails and/or all toenails.
- Group Loceryl Nail Lacquer alone:
- Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails.
- All eligible subejct with no clinical sign of clinical aggravation of Onychomycosis at week 12, could continue to apply Loceryl Nail Lacquer alone, once a week for 15 additional months (or less in case of complete cure).
- Conditions
- Foot Dermatoses
- Being tested
- Loceryl NL + Cosmetic varnish, Loceryl NL 12 weeks, Loceryl NL 15 months
- Keywords
- Onychomycosis, antifungal
- 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 NL + Cosmetic varnishDrug
Loceryl NL + Cosmetic varnish once/week for 12 weeks
Loceryl NL 12 weeksDrug
Loceryl NL once/week for 12 weeks
Loceryl NL 15 monthsDrug
Loceryl once/week for additional 15 months
| Study group | Role | What they receive |
|---|---|---|
| Investigator blinded Loceryl NL+ Cosmetic varnish | Experimental | Loceryl NL+ Cosmetic varnish once/week for 12 weeks on right or left foot toenails Receives: Drug: Loceryl NL + Cosmetic varnish; Drug: Loceryl NL 15 months |
| Investigator blinded Loceryl NL alone | Experimental | Loceryl NL once/week for 12 weeks on right or left foot toenails Receives: Drug: Loceryl NL 12 weeks; Drug: Loceryl NL 15 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Antifungal Activity of Loceryl Nail Lacquer
Measurement of diameter of zones of inhibition (mm) produced by residual drug in toenails
Measured: Week 12
Secondary outcomes (1)
Absence of Dermatophytes in Nail Samples Culture
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 posted22 Dec 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2016
- Study completionJan 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321098
- Sponsor's protocol ID
- RD.03.SPR.29106
- Other IDs
- 2013-000544-26
- Acronym
- COOL
- Status last verified
- Jan 2023
- First submitted
- 8 Dec 2014
- Last updated
- 19 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Antifungal Activity of Loceryl Nail Lacquer 5% When Used Concomitantly With a Cosmetic Nail Varnish Compared to a Loceryl Nail Lacquer (NL) 5% Alone in Treatment of Toenail Distal Subungual Onychomycosis
- ClinicalTrials.gov ID
- NCT02321098
- Acronym / sponsor ID
- COOL / RD.03.SPR.29106
- Conditions
- Foot Dermatoses
- Keywords
- Onychomycosis, antifungal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Feb 2014 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 22 Dec 2014 (estimated)
- Results
- Posted 9 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 is to compare efficacy, in terms of antifungal activity of Loceryl Nail Lacquer associated with a Cosmetic Varnish and Loceryl Nail Lacquer alone, in the treatment of mild to moderate toenail Distal Subungual Onychomycosis.
The second objective of this study will be photographic follow-up of clinical improvement and cure after the initial treatment period of 12 weeks, for 15 additional months.
Detailed description
Study center:
A total of 50 subjects were to be included in 1 site in Iceland.
Methodology:
- Group Loceryl Nail Lacquer+ Cosmetic Varnish:
- Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails,
- Cosmetic varnish to be applied once weekly for 12 weeks on all affected toenails and/or all toenails.
- Group Loceryl Nail Lacquer alone:
- Loceryl Nail Lacquer to be applied once weekly for 12 weeks on all affected toenails.
- All eligible subejct with no clinical sign of clinical aggravation of Onychomycosis at week 12, could continue to apply Loceryl Nail Lacquer alone, once a week for 15 additional months (or less in case of complete cure).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigator blinded Loceryl NL+ Cosmetic varnish | Experimental | Drug: Loceryl NL + Cosmetic varnish, Drug: Loceryl NL 15 monthsLoceryl NL+ Cosmetic varnish once/week for 12 weeks on right or left foot toenails |
| Investigator blinded Loceryl NL alone | Experimental | Drug: Loceryl NL 12 weeks, Drug: Loceryl NL 15 monthsLoceryl NL once/week for 12 weeks on right or left foot toenails |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with a mild to moderate Distal Subungual Onychomycosis (DSO) on at least 1 great toenail chosen as a Target nail
- Subjects must have maximum of 50% of nail distal edge involved
- Subjects with positive mycological results (direct microscopy and culture) of the Target nail for dermatophytes or Yeast (including Candida) at Screening
Key exclusion criteria (3 listed)
- Subjects with clinically important abnormal physical findings at the Screening/Baseline visit
- Subjects with Lichen planus, eczema, psoriasis, or other abnormalities of the nail unit
- Subjects with known immunodeficiencies, 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 NL + Cosmetic varnishLoceryl NL + Cosmetic varnish once/week for 12 weeks | Drug | Investigator blinded Loceryl NL+ Cosmetic varnish |
| Loceryl NL 12 weeksLoceryl NL once/week for 12 weeks | Drug | Investigator blinded Loceryl NL alone |
| Loceryl NL 15 monthsLoceryl once/week for additional 15 months | Drug | Investigator blinded Loceryl NL alone, Investigator blinded Loceryl NL+ Cosmetic varnish |
Primary outcome
Measurement of Antifungal Activity of Loceryl Nail Lacquer
Time frame: Week 12
Measurement of diameter of zones of inhibition (mm) produced by residual drug in toenails
1 secondary outcome
Absence of Dermatophytes in Nail Samples Culture
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 19 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 + Cosmetic varnish, Loceryl NL 12 weeks and Loceryl NL 15 months 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 3 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 19 Jan 2023. 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?
Yes. Results are posted in the registry (first posted 9 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?
Measurement of Antifungal Activity of Loceryl Nail Lacquer (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 19 Jan 2023.