Pediatric Subjects With Tinea Corporis
Primary Purpose
Tinea Corporis
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Naftin Cream
Placebo Cream
Sponsored by
About this trial
This is an interventional treatment trial for Tinea Corporis focused on measuring Tinea Corporis, Ringworm
Eligibility Criteria
Inclusion Criteria:
- Males or non-pregnant females 2 years of age to 17 years, 11 months, of any race. Females of child bearing potential must have a negative urine pregnancy test.
- Presence of tinea corporis by clinical evidence of a tinea infection of at least moderate erythema, moderate induration, and mild pruritus.
- KOH positive and culture positive baseline skin scrapings obtained form the site with the mose severely affected lesion or a representative site of the overall severity.
Exclusion Criteria:
- Tinea infection of the face, scalp, groin, and/or feet
- A life-threatening condition in the opinion of the investigator (ex. autoimmune deficiency syndrome, cancer, etc) within the last 6 months.
- Subjects with abnormal findings- physical or laboratory- that are considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results
- Subjects with a known hypersensitivity or other contradictions to study medications or their components.
- Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
- Uncontrolled diabetes mellitus.
- Hemodialysis or chronic ambulatory peritoneal dialysis therapy.
- Current diagnosis of immunocompromising conditions.
- Current evidence of compromised skin, atopic or contact dermatitis, eczema, impetigo, lichen planus, pityriasis rosea, pityriasis versicolor, psoriasis, seborrhoeic dermatitis and syphilis.
- Severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection
- Patients with tinea corporis who have concurrent dermatophytosis of the scalp, beard or nails.
Sites / Locations
- Merz Investigative Site#001316
- Investigative Site# 0010320
- Merz Investigative Site#001313
- Merz Investigative Site#001301
- Merz Investigative Site#001312
- Merz Investigative Site#001311
- Merz Investigative Site #001310
- Merz Investigative Site#001307
- Merz Investigative Site#001309
- Merz Investigative Site#001314
- Merz Investigative Site#001126
- Merz Investigative Site#001293
- Investigative Site# 0010319
- Merz Investigative Site#001097
- Merz Investigative Site#180002
- Merz Investigative Site# 180001
- Merz Investigative Site#504001
- Merz Investigative Site#507001
- Merz Investigative Site#001279
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Naftin Cream, 2%
Placebo Cream
Arm Description
Once Daily
Once Daily
Outcomes
Primary Outcome Measures
Primary Efficacy
Complete cure defined by negative KOH result and negative dermatophyte culture
Secondary Outcome Measures
Secondary Efficacy
Treatment Effectiveness defined as negative KOH, negative culture, and improved sign and symptoms.
Full Information
NCT ID
NCT02227290
First Posted
August 25, 2014
Last Updated
October 27, 2016
Sponsor
Merz North America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02227290
Brief Title
Pediatric Subjects With Tinea Corporis
Official Title
A Phase 4, Double-Blind, Randomized, Vehicle-Controlled, Multicenter, Parallel Group Evaluation of the Efficacy and Safety of Naftin (Naftifine Hydrochloride) Cream, 2% in Pediatric Subjects With Tinea Corporis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz North America, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is being done to see how well the study cream works when applied once a day to affected area of child (where they have ringworm). The results will be compared to those seen with a placebo cream which has no active ingredient. Safety of the cream will also be measured.
Detailed Description
The objectives of this study are to evaluate the safety and efficacy of Naftin (naftifine hydrochloride) Cream, 2% applied once daily for 2 weeks, compared to its vehicle in the treatment of pediatric subjects aged 2 to 17 years and 11 months with positive potassium hydroxide (KOH), positive dermatophyte culture, and clinical signs and symptoms of tinea corporis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Corporis
Keywords
Tinea Corporis, Ringworm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Naftin Cream, 2%
Arm Type
Experimental
Arm Description
Once Daily
Arm Title
Placebo Cream
Arm Type
Placebo Comparator
Arm Description
Once Daily
Intervention Type
Drug
Intervention Name(s)
Naftin Cream
Intervention Type
Drug
Intervention Name(s)
Placebo Cream
Primary Outcome Measure Information:
Title
Primary Efficacy
Description
Complete cure defined by negative KOH result and negative dermatophyte culture
Time Frame
Day 21
Secondary Outcome Measure Information:
Title
Secondary Efficacy
Description
Treatment Effectiveness defined as negative KOH, negative culture, and improved sign and symptoms.
Time Frame
Day 21
Other Pre-specified Outcome Measures:
Title
Clinical Success at Days 14 and 21
Description
Defined as sign and symptom scores of 0 or 1
Time Frame
Day 14 and Day 21
Title
Clinical cure at Days 14 and 21
Description
Defined as erythema, induration, and pruritus score of 0.
Time Frame
Days 14 and 21
Title
Subject Satisfaction
Description
Assessment on 5 point scale or category of improvement from baseline.
Time Frame
Days 14 and 21
Title
Complete Cure
Description
Defined as negative mycology and abscence of signs/symptoms.
Time Frame
Day 14
Title
Treatment of Effectiveness
Description
Defined as negative KOH, negative culture, and signs/symptoms.
Time Frame
Day 14
Title
Mycology Cure
Description
Defined as negative KOH result and negative dermatophyte culture.
Time Frame
Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males or non-pregnant females 2 years of age to 17 years, 11 months, of any race. Females of child bearing potential must have a negative urine pregnancy test.
Presence of tinea corporis by clinical evidence of a tinea infection of at least moderate erythema, moderate induration, and mild pruritus.
KOH positive and culture positive baseline skin scrapings obtained form the site with the mose severely affected lesion or a representative site of the overall severity.
Exclusion Criteria:
Tinea infection of the face, scalp, groin, and/or feet
A life-threatening condition in the opinion of the investigator (ex. autoimmune deficiency syndrome, cancer, etc) within the last 6 months.
Subjects with abnormal findings- physical or laboratory- that are considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results
Subjects with a known hypersensitivity or other contradictions to study medications or their components.
Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
Uncontrolled diabetes mellitus.
Hemodialysis or chronic ambulatory peritoneal dialysis therapy.
Current diagnosis of immunocompromising conditions.
Current evidence of compromised skin, atopic or contact dermatitis, eczema, impetigo, lichen planus, pityriasis rosea, pityriasis versicolor, psoriasis, seborrhoeic dermatitis and syphilis.
Severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection
Patients with tinea corporis who have concurrent dermatophytosis of the scalp, beard or nails.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Fleischer, MD
Organizational Affiliation
Merz North America, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Merz Investigative Site#001316
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Investigative Site# 0010320
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Merz Investigative Site#001313
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Merz Investigative Site#001301
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Merz Investigative Site#001312
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Merz Investigative Site#001311
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Merz Investigative Site #001310
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Merz Investigative Site#001307
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Merz Investigative Site#001309
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Merz Investigative Site#001314
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
Merz Investigative Site#001126
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Merz Investigative Site#001293
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
Facility Name
Investigative Site# 0010319
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Merz Investigative Site#001097
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Merz Investigative Site#180002
City
San Cristobal
Country
Dominican Republic
Facility Name
Merz Investigative Site# 180001
City
Santo Domingo
Country
Dominican Republic
Facility Name
Merz Investigative Site#504001
City
San Pedro Sula
Country
Honduras
Facility Name
Merz Investigative Site#507001
City
Panama City
Country
Panama
Facility Name
Merz Investigative Site#001279
City
Cidra
ZIP/Postal Code
00739
Country
Puerto Rico
12. IPD Sharing Statement
Learn more about this trial
Pediatric Subjects With Tinea Corporis
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