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
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.
- 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