Pediatric Subjects With Tinea Corporis

NCT02227290 | Completed Phase 4

• 1 other identifier: MUS90200_4024_1
• Study Type: interventional
• Target: 230
• Locations: 5 countries
• Sites: 19

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.

Conditions

Tinea Corporis

Keywords

Tinea Corporis; Ringworm

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy

  Complete cure defined by negative KOH result and negative dermatophyte culture

  Day 21

Secondary Outcomes (1)

• Secondary Efficacy

  Day 21

Other Outcomes (6)

• Clinical Success at Days 14 and 21

  Day 14 and Day 21

• Clinical cure at Days 14 and 21

  Days 14 and 21

• Subject Satisfaction

  Days 14 and 21

Study Arms (2)

Naftin Cream, 2%

EXPERIMENTAL

Once Daily

Drug: Naftin Cream

Placebo Cream

PLACEBO COMPARATOR

Once Daily

Drug: Placebo Cream

Interventions

Naftin Cream DRUG

Naftin Cream, 2%

Placebo Cream DRUG

Placebo Cream

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merz North America, Inc.: lead

Study Sites (19)

Merz Investigative Site#001316

Tucson, Arizona, 85712, United States

Location

Investigative Site# 0010320

Encino, California, 91436, United States

Location

Merz Investigative Site#001313

Fremont, California, 94538, United States

Location

Merz Investigative Site#001301

San Diego, California, 92102, United States

Location

Merz Investigative Site#001312

Miami, Florida, 33144, United States

Location

Merz Investigative Site#001311

Miami, Florida, 33175, United States

Location

Merz Investigative Site #001310

Miramar, Florida, 33027, United States

Location

Merz Investigative Site#001307

Saint Joseph, Missouri, 64506, United States

Location

Merz Investigative Site#001309

Omaha, Nebraska, 68114, United States

Location

Merz Investigative Site#001314

Henderson, Nevada, 89074, United States

Location

Merz Investigative Site#001126

Raleigh, North Carolina, 27612, United States

Location

Merz Investigative Site#001293

Winston-Salem, North Carolina, 27104, United States

Location

Investigative Site# 0010319

Gresham, Oregon, 97030, United States

Location

Merz Investigative Site#001097

Nashville, Tennessee, 37215, United States

Location

Merz Investigative Site#180002

San Cristóbal, Dominican Republic

Location

Merz Investigative Site# 180001

Santo Domingo, Dominican Republic

Location

Merz Investigative Site#504001

San Pedro Sula, Honduras

Location

Merz Investigative Site#507001

Panama City, Panama

Location

Merz Investigative Site#001279

Cidra, 00739, Puerto Rico

Location

MeSH Terms

Conditions

Tinea

Condition Hierarchy (Ancestors)

Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alan Fleischer, MD

  Merz North America, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2014
• First Posted: August 28, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 28, 2016

Record last verified: 2016-10

Locations

PA (1); DO (2); US (14); PR (1); HO (1)