Pediatric Subjects With Tinea Corporis
Sleutelwoorden
Abstract
Omschrijving
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.
Datums
| Laatst geverifieerd: | 09/30/2016 |
| Eerste ingediend: | 08/24/2014 |
| Geschatte inschrijving ingediend: | 08/25/2014 |
| Eerst geplaatst: | 08/27/2014 |
| Laatste update ingediend: | 10/26/2016 |
| Laatste update geplaatst: | 10/27/2016 |
| : | 10/05/2016 |
| : | 10/05/2016 |
| : | 10/06/2016 |
| Werkelijke startdatum van het onderzoek: | 07/31/2014 |
| Geschatte primaire voltooiingsdatum: | 10/31/2015 |
| Geschatte voltooiingsdatum van het onderzoek: | 11/30/2015 |
Conditie of ziekte
Interventie / behandeling
Drug: Naftin Cream, 2%
Drug: Placebo Cream
Fase
Armgroepen
| Arm | Interventie / behandeling |
|---|---|
| Experimental: Naftin Cream, 2% Once Daily | Drug: Naftin Cream, 2% |
| Placebo Comparator: Placebo Cream Once Daily | Drug: Placebo Cream |
Geschiktheidscriteria
| Leeftijden die in aanmerking komen voor studie | 2 Years Naar 2 Years |
| Geslachten die in aanmerking komen voor studie | All |
| Accepteert gezonde vrijwilligers | Ja |
| Criteria | 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. |
Resultaat
Primaire uitkomstmaten
1. Primary Efficacy [Day 21]
Secundaire uitkomstmaten
1. Secondary Efficacy [Day 21]
Andere uitkomstmaten
1. Clinical Success at Days 14 and 21 [Day 14 and Day 21]
2. Clinical cure at Days 14 and 21 [Days 14 and 21]
3. Subject Satisfaction [Days 14 and 21]
4. Complete Cure [Day 14]
5. Treatment of Effectiveness [Day 14]
6. Mycology Cure [Day 14]
