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Antifungal
Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Cruris
Phase 3
Waitlist Available
Led By Lawrence Parish, MD
Research Sponsored by Merz North America, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4 post-baseline
Awards & highlights
Pivotal Trial
Summary
A research study to compare the safety and effectiveness of an investigational medication called NAFT-500 to placebo (no active treatment), when used in subjects with tinea cruris, also known as jock itch.
Eligible Conditions
- Jock Itch
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 4 post-baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4 post-baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Subjects
Secondary study objectives
Mycological Cure and Treatment Effectiveness
Side effects data
From 2009 Phase 3 trial • 707 Patients • NCT007501394%
Headache
2%
Application Site Irritation
2%
Nasopharyngitis
2%
Pain
1%
Blood Creatinine Increased
1%
Alanine Aminotransferase Increased
1%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo 2-wks
Naftin 1%
NAFT-500
Placebo 4-wks
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1Experimental Treatment1 Intervention
NAFT-500
Group II: 2Placebo Group1 Intervention
placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NAFT-500
2008
Completed Phase 3
~1050
Find a Location
Who is running the clinical trial?
Merz North America, Inc.Lead Sponsor
65 Previous Clinical Trials
9,199 Total Patients Enrolled
Lawrence Parish, MDPrincipal InvestigatorPaddington Testing Company
3 Previous Clinical Trials
1,618 Total Patients Enrolled