A Randomized Study Evaluating the Safety and Efficacy of Luliconazole Cream in Pediatric Subjects With Tinea Corporis

Tinea Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02491112
• Other study ID #: V01-LUZB-401
• Status: Not yet recruiting
• Phase: Phase 4
• First received: July 1, 2015
• Last updated: September 11, 2015
• Start date: October 2015
• Est. completion date: March 2016

Study information

• Verified date: September 2015
• Source: Valeant Pharmaceuticals
• Contact: Anya Loncaric, MS
• Phone: 510-259-5284
• Email: aloncaric[@]solta.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the safety and efficacy of Luliconazole Cream 1% when applied topically for 7 days in pediatric subjects 2 years to 17 years of age with tinea corporis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Subjects (or legal guardian) with the ability and willingness to sign a written informed consent and/or assent (age appropriate).

2. Subjects of either gender must be 2 years to < 18 years of age (2 to 17 years of age, inclusive).

3. Subjects with a clinical diagnosis of tinea corporis characterized by clinical evidence of a tinea infection

4. Subjects must be in good general health and free of any disease that in the Investigator's opinion might interfere with the study evaluations.

Exclusion Criteria:

1. Subjects with active atopic or contact dermatitis in the treatment area.

2. Subjects with severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection.

3. Female subjects who are pregnant and/or nursing or planning a pregnancy during the course of the trial.

4. Subjects who are immunocompromised (due to disease, e.g., HIV or medications).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinea

Intervention

Drug:
• Luliconazole Cream 1%
Application of Luliconazole Cream 1% once daily for 7 days
• Vehicle Cream
Application of Vehicle Cream once daily for 7 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Valeant Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who achieve "mycological cure" at Day 28 (3 weeks post-treatment)	Mycological cure - negative potassium hydroxide (KOH) examination and negative fungal culture.	28 days post-treatment	No
Secondary	Proportion of subjects who achieve "clinical cure" at Day 28 (3 weeks post-treatment)	Clinical cure - absence of the signs or symptoms of tinea corporis (i.e. score of 0 using a 4-point severity score (0-none; 1-mild; 2-moderate; and 3-severe) for each of the individual signs of tinea corporis - erythema, scaling, pruritus).	28 days post-treatment	No
Secondary	Proportion of subjects who achieve "complete clearance" at Day 28 (3 weeks post-treatment).	Complete clearance is defined as achieving both clinical cure and mycological cure	28 days post-treatment	No
Secondary	Proportion of subjects who achieve "effective treatment" at Day 7 (end of treatment), Day 14 (1 week post-treatment), Day 21, (2 weeks post-treatment), Day 28 (3 weeks post-treatment)	Effective treatment is defined as negative KOH and culture and at most mild erythema and/or scaling and no pruritus	7, 14, 21, and 28 days post-treatment	No
Secondary	Plasma levels of parent luliconazole and the Z-form of luliconazole obtained at steady state and approximately tmax	Pharmacokinetics	Prior to and 6 hours after the final dose of study drug on Day 7	No