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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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.

Germany1 site

Study site
Tübingen

Other trials in Germany

About this study

Official title: Subject Adherence and Satisfaction for Treatment of Onychomycosis With Loceryl Nail Lacquer 5% Versus Ciclopirox Nail Lacquer

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 groups in NCT02679911
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.

Sep 2015Jun 2016

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Foot Dermatoses trials

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.

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

Results posted to the registry on 3 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Loceryl NL and Ciclopirox NL	20	20

Primary outcome: Percent of "in Label" Adherent Subjects

Time frame: Week 12. Number. Unit: percentage of participants

Measure	Loceryl NL n = 20	Ciclopirox NL n = 20
Value	85	60

Population analysed: Intention To Treat popoulation (ITT)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: During the study (12 weeks). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Loceryl NL + Ciclopirox NL	0 of 20 (0%)	3 of 20 (15%)	0 of 20

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

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Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
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EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer
Recruiting
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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.

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?

On the ClinicalTrials.gov record for NCT02679911.

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.