Safety and Efficacy of Product 33525 (Luliconazole Cream 1%) in Pediatric Participants With Tinea Corporis

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Bausch Health

Status and phase

Completed
Phase 4

Conditions

Tinea Corporis

Treatments

Drug: Luliconazole Cream 1%
Drug: Vehicle Cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT02767947
V01-LUZB-401

Details and patient eligibility

About

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.

Enrollment

75 patients

Sex

All

Ages

2 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

75 participants in 2 patient groups, including a placebo group

Luliconazole Cream 1%
Experimental group
Description:
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.
Treatment:
Drug: Luliconazole Cream 1%
Vehicle Cream
Placebo Comparator group
Description:
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.
Treatment:
Drug: Vehicle Cream

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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