Clinical trial NCT02227290: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tinea Corporis
Keywords: Tinea Corporis
Ringworm
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-28
Enrollment: 230
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Primary Efficacy
timeFrame: Day 21
Secondary outcomes:
measure: Secondary Efficacy
timeFrame: Day 21
Other outcomes:
measure: Clinical Success at Days 14 and 21
timeFrame: Day 14 and Day 21
measure: Clinical cure at Days 14 and 21
timeFrame: Days 14 and 21
measure: Subject Satisfaction
timeFrame: Days 14 and 21
measure: Complete Cure
timeFrame: Day 14
measure: Treatment of Effectiveness
timeFrame: Day 14
measure: Mycology Cure
timeFrame: Day 14
Locations:
city: Tucson
country: United States
facility: Merz Investigative Site#001316
state: Arizona
city: Encino
country: United States
facility: Investigative Site# 0010320
state: California
city: Fremont
country: United States
facility: Merz Investigative Site#001313
state: California
city: San Diego
country: United States
facility: Merz Investigative Site#001301
state: California
city: Miami
country: United States
facility: Merz Investigative Site#001312
state: Florida
city: Miami
country: United States
facility: Merz Investigative Site#001311
state: Florida
city: Miramar
country: United States
facility: Merz Investigative Site #001310
state: Florida
city: Saint Joseph
country: United States
facility: Merz Investigative Site#001307
state: Missouri
city: Omaha
country: United States
facility: Merz Investigative Site#001309
state: Nebraska
city: Henderson
country: United States
facility: Merz Investigative Site#001314
state: Nevada
city: Raleigh
country: United States
facility: Merz Investigative Site#001126
state: North Carolina
city: Winston Salem
country: United States
facility: Merz Investigative Site#001293
state: North Carolina
city: Gresham
country: United States
facility: Investigative Site# 0010319
state: Oregon
city: Nashville
country: United States
facility: Merz Investigative Site#001097
state: Tennessee
city: San Cristobal
country: Dominican Republic
facility: Merz Investigative Site#180002
city: Santo Domingo
country: Dominican Republic
facility: Merz Investigative Site# 180001
city: San Pedro Sula
country: Honduras
facility: Merz Investigative Site#504001
city: Panama City
country: Panama
facility: Merz Investigative Site#507001
city: Cidra
country: Puerto Rico
facility: Merz Investigative Site#001279
Study officials:
affiliation: Merz North America, Inc.
name: Alan Fleischer, MD
role: STUDY_DIRECTOR
References: