Status:
COMPLETED
Pediatric Subjects With Tinea Corporis
Lead Sponsor:
Merz North America, Inc.
Conditions:
Tinea Corporis
Eligibility:
All Genders
2-17 years
Phase:
PHASE4
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 cr...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT02227290
Start Date
August 1 2014
End Date
December 1 2015
Last Update
October 28 2016
Active Locations (19)
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1
Merz Investigative Site#001316
Tucson, Arizona, United States, 85712
2
Investigative Site# 0010320
Encino, California, United States, 91436
3
Merz Investigative Site#001313
Fremont, California, United States, 94538
4
Merz Investigative Site#001301
San Diego, California, United States, 92102