|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02767947 |
|
Date of registration:
|
06/05/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Safety and Efficacy of Product 33525 (Luliconazole Cream 1%) in Pediatric Participants With Tinea Corporis
|
|
Scientific title:
|
A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Product 33525 in Pediatric Subjects With Tinea Corporis |
|
Date of first enrolment:
|
February 8, 2016 |
|
Target sample size:
|
75 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02767947 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Dominican Republic
|
Honduras
| | | | | | |
|
Contacts
|
|
Name:
|
Anya Loncaric |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Valeant Pharmaceuticals |
| | |
|
Key inclusion & exclusion criteria
|
Key Inclusion Criteria:
- 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:
- 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.
Age minimum:
2 Years
Age maximum:
17 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Tinea Corporis
|
|
Intervention(s)
|
|
Drug: Luliconazole Cream 1%
|
|
Drug: Vehicle Cream
|
|
Primary Outcome(s)
|
|
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]
|
|
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]
|
|
Secondary ID(s)
|
|
V01-LUZB-401
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|