Tinea CorporisPhase 4NCT02767947
Safety and Efficacy of Product 33525 (Luliconazole Cream 1%) in Pediatric Participants With Tinea Corporis
A Phase 4 study testing Luliconazole Cream 1% in people with Tinea Corporis, run by Bausch Health Americas, Inc. at 3 sites in 2 countries.
Trial summary
The objective of this study was to evaluate the safety, efficacy, and pharmacokinetics of luliconazole cream 1% when applied topically for 7 days in pediatric participants 2 years to 17 years of age (inclusive) with tinea corporis. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Tinea Corporis
- What is being tested?
- Luliconazole Cream 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 8 Feb 2016to 22 Sep 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants (or legal guardian/caregiver) with the ability and willingness to sign a written informed consent and/or assent (age appropriate).
- Participants of either gender must be at least 2 years to less than (<) 18 years of age (2 to 17 years, inclusive).
- Participants with a clinical diagnosis of tinea corporis characterized by clinical evidence of a tinea infection (at least moderate erythema, mild scaling, and moderate pruritus).
- Participants must be in good general health and free of any disease that in the Investigator's opinion might interfere with the study evaluations.
- Participants/caregiver must be able to communicate, be able to understand the study procedures, and be willing to comply with the study requirements.
Who cannot join
- Participants with active atopic or contact dermatitis in the area to be treated.
- Participants with severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection.
- Female participants who are pregnant and/or nursing or planning a pregnancy during the course of the trial. Participants who test positive for pregnancy after start study drug will be discontinued from study drug but will be followed for safety purposes.
- Participants who are immunocompromised (due to disease, for example; human immunodeficiency virus [HIV] or medications).
- Participants who have a recent history of or current drug or alcohol abuse.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Dominican Republic2 sites
Valeant Site 03
San Cristobal, 91000
Valeant Site 01
Santo Domingo, 10700
About this study
Official title: A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Product 33525 in Pediatric Subjects With Tinea Corporis
The objective of this study was to evaluate the safety, efficacy, and pharmacokinetics of luliconazole cream 1% when applied topically for 7 days in pediatric participants 2 years to 17 years of age (inclusive) with tinea corporis.
- Conditions
- Tinea Corporis
- Being tested
- Luliconazole Cream 1%, Vehicle Cream
- Medical subject headings
- Tinea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luliconazole Cream 1%Drug
Also called Product 33525
Luliconazole cream will be applied per schedule specified in the arm.
Vehicle CreamDrug
Vehicle cream will be applied per schedule specified in the arm.
| Study group | Role | What they receive |
|---|---|---|
| Luliconazole Cream 1% | Experimental | Luliconazole cream 1% will be applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area. Receives: Drug: Luliconazole Cream 1% |
| Vehicle Cream | Placebo comparator | Vehicle cream (containing no active ingredient) will be applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area. Receives: Drug: Vehicle Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating Plasma Concentration of Luliconazole at Day 7 (Pre-Dose)
Plasma levels of luliconazole were obtained at steady-state (within 15 minutes prior to the final dose of the study drug on Day 7) and approximately the time of maximum concentration (tmax) (6 hours after the final dose of study drug on Day 7).
Measured: Pre-dose (within 15 minutes prior to the final dose of the drug) on Day 7
Circulating Plasma Concentration of Luliconazole at Day 7 (6 Hours Post-Dose)
Plasma levels of luliconazole were obtained at steady-state (within 15 minutes prior to the final dose of the study drug on Day 7) and approximately the tmax (6 hours after the final dose of study drug on Day 7).
Measured: 6 hours after the final dose of the drug on Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study start8 Feb 2016
- Primary completion29 Jun 2016
- Study completion22 Sep 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 Tinea CorporisStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anya Loncaric, Study director, Valeant Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767947
- Sponsor's protocol ID
- V01-LUZB-401
- Status last verified
- Nov 2019
- First submitted
- 6 May 2016
- Last updated
- 27 Nov 2019
- 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 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Product 33525 in Pediatric Subjects With Tinea Corporis
- ClinicalTrials.gov ID
- NCT02767947
- Acronym / sponsor ID
- V01-LUZB-401
- Conditions
- Tinea Corporis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Feb 2016 (actual)
- Primary completion
- 29 Jun 2016 (actual)
- Study completion
- 22 Sep 2016 (actual)
- First posted
- 11 May 2016 (estimated)
- Results
- Posted 27 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to evaluate the safety, efficacy, and pharmacokinetics of luliconazole cream 1% when applied topically for 7 days in pediatric participants 2 years to 17 years of age (inclusive) with tinea corporis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Luliconazole Cream 1% | Experimental | Drug: Luliconazole Cream 1%Luliconazole cream 1% will be applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area. |
| Vehicle Cream | Placebo comparator | Drug: Vehicle CreamVehicle cream (containing no active ingredient) will be applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Participants (or legal guardian/caregiver) with the ability and willingness to sign a written informed consent and/or assent (age appropriate).
- Participants of either gender must be at least 2 years to less than (<) 18 years of age (2 to 17 years, inclusive).
- Participants with a clinical diagnosis of tinea corporis characterized by clinical evidence of a tinea infection (at least moderate erythema, mild scaling, and moderate pruritus).
- Participants must be in good general health and free of any disease that in the Investigator's opinion might interfere with the study evaluations.
- Participants/caregiver must be able to communicate, be able to understand the study procedures, and be willing to comply with the study requirements.
Key exclusion criteria (5 listed)
- Participants with active atopic or contact dermatitis in the area to be treated.
- Participants with severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection.
- Female participants who are pregnant and/or nursing or planning a pregnancy during the course of the trial. Participants who test positive for pregnancy after start study drug will be discontinued from study drug but will be followed for safety purposes.
- Participants who are immunocompromised (due to disease, for example; human immunodeficiency virus [HIV] or medications).
- Participants who have a recent history of or current drug or alcohol abuse.
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 |
|---|---|---|
| Luliconazole Cream 1%Also: Product 33525Luliconazole cream will be applied per schedule specified in the arm. | Drug | Luliconazole Cream 1% |
| Vehicle CreamVehicle cream will be applied per schedule specified in the arm. | Drug | Vehicle Cream |
Primary outcome
Circulating Plasma Concentration of Luliconazole at Day 7 (Pre-Dose)
Time frame: Pre-dose (within 15 minutes prior to the final dose of the drug) on Day 7
Plasma levels of luliconazole were obtained at steady-state (within 15 minutes prior to the final dose of the study drug on Day 7) and approximately the time of maximum concentration (tmax) (6 hours after the final dose of study drug on Day 7).
Circulating Plasma Concentration of Luliconazole at Day 7 (6 Hours Post-Dose)
Time frame: 6 hours after the final dose of the drug on Day 7
Plasma levels of luliconazole were obtained at steady-state (within 15 minutes prior to the final dose of the study drug on Day 7) and approximately the tmax (6 hours after the final dose of study drug on Day 7).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Tinea Corporis
Not yet recruitingPhase 4
Comparative Efficacy of Luliconazole and Bifonazole Combined With Itraconazole in Dermatophytosis
Tinea Corporis,Tinea Cruris,Tinea Faciei
RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
Not yet recruitingObservational study
Clinical, Dermoscopic, and Mycological Evaluations of Resistant Dermatophytosis
Fungal Skin Infection, Tinea Corporis
Not yet recruitingPhase 4
Comparison of Itraconazole With Itraconazole and Isotretinoin in the Treatment Duration, Safety a n d Cure Rate in Adult Patients of Tinea Corporis/ Cruris-A Randomised Controlled Trail
Tinea Corporis
RecruitingPhase 4
Comparing the Efficacy of Oral Fluconazole Versus Oral Itraconazole in Treating Resistant Tinea Corporis
Tinea Corporis, Dermatophytosis
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.
Anya Loncaric study director
Valeant Pharmaceuticals
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Luliconazole Cream 1% in people with Tinea Corporis, run by Bausch Health Americas, Inc. at 3 sites in 2 countries.
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 5 inclusion and 5 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 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Dominican Republic, Honduras. 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. Some participants in this study may receive a placebo. 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 27 Nov 2019). 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?
Circulating Plasma Concentration of Luliconazole at Day 7 (Pre-Dose) (time frame: Pre-dose (within 15 minutes prior to the final dose of the drug) on Day 7). The study lists 2 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 27 Nov 2019.