Tinea Corporis
Conditions
Keywords
Tinea Corporis, Ringworm
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.
Interventions
DRUGNaftin Cream
DRUGPlacebo Cream
Sponsors
Merz North America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy | Day 21 | Complete cure defined by negative KOH result and negative dermatophyte culture |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Efficacy | Day 21 | Treatment Effectiveness defined as negative KOH, negative culture, and improved sign and symptoms. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction | Days 14 and 21 | Assessment on 5 point scale or category of improvement from baseline. |
| Complete Cure | Day 14 | Defined as negative mycology and abscence of signs/symptoms. |
| Clinical Success at Days 14 and 21 | Day 14 and Day 21 | Defined as sign and symptom scores of 0 or 1 |
| Mycology Cure | Day 14 | Defined as negative KOH result and negative dermatophyte culture. |
| Treatment of Effectiveness | Day 14 | Defined as negative KOH, negative culture, and signs/symptoms. |
| Clinical cure at Days 14 and 21 | Days 14 and 21 | Defined as erythema, induration, and pruritus score of 0. |
Countries
Dominican Republic, Honduras, Panama, Puerto Rico, United States
Outcome results
None listed