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Clinical Trials/NCT02227290
NCT02227290CompletedPhase 4

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

Merz North America, Inc.19 sites in 5 countries230 target enrollmentStarted: August 2014Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
230
Locations
19
Primary Endpoint
Primary Efficacy
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
2 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Naftin Cream, 2%

Experimental

Once Daily

Intervention: Naftin Cream (Drug)

Placebo Cream

Placebo Comparator

Once Daily

Intervention: Placebo Cream (Drug)

Outcomes

Primary Outcomes

Primary Efficacy

Time Frame: Day 21

Complete cure defined by negative KOH result and negative dermatophyte culture

Secondary Outcomes

  • Secondary Efficacy(Day 21)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (19)

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