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Pediatric Subjects With Tinea Corporis

NCT ID: NCT02227290

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Tinea Corporis

Keywords

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Tinea Corporis Ringworm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Naftin Cream, 2%

Once Daily

Group Type EXPERIMENTAL

Naftin Cream

Intervention Type DRUG

Placebo Cream

Once Daily

Group Type PLACEBO_COMPARATOR

Placebo Cream

Intervention Type DRUG

Interventions

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Naftin Cream

Intervention Type DRUG

Placebo Cream

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merz North America, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alan Fleischer, MD

Role: STUDY_DIRECTOR

Merz North America, Inc.

Locations

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Merz Investigative Site#001316

Tucson, Arizona, United States

Site Status

Investigative Site# 0010320

Encino, California, United States

Site Status

Merz Investigative Site#001313

Fremont, California, United States

Site Status

Merz Investigative Site#001301

San Diego, California, United States

Site Status

Merz Investigative Site#001312

Miami, Florida, United States

Site Status

Merz Investigative Site#001311

Miami, Florida, United States

Site Status

Merz Investigative Site #001310

Miramar, Florida, United States

Site Status

Merz Investigative Site#001307

Saint Joseph, Missouri, United States

Site Status

Merz Investigative Site#001309

Omaha, Nebraska, United States

Site Status

Merz Investigative Site#001314

Henderson, Nevada, United States

Site Status

Merz Investigative Site#001126

Raleigh, North Carolina, United States

Site Status

Merz Investigative Site#001293

Winston-Salem, North Carolina, United States

Site Status

Investigative Site# 0010319

Gresham, Oregon, United States

Site Status

Merz Investigative Site#001097

Nashville, Tennessee, United States

Site Status

Merz Investigative Site#180002

San Cristóbal, , Dominican Republic

Site Status

Merz Investigative Site# 180001

Santo Domingo, , Dominican Republic

Site Status

Merz Investigative Site#504001

San Pedro Sula, , Honduras

Site Status

Merz Investigative Site#507001

Panama City, , Panama

Site Status

Merz Investigative Site#001279

Cidra, , Puerto Rico

Site Status

Countries

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United States Dominican Republic Honduras Panama Puerto Rico

Other Identifiers

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MUS90200_4024_1

Identifier Type: -

Identifier Source: org_study_id