Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Ti⦠(NCT01580891) | Clinical Trial Compass
CompletedPhase 1
Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis
1,053 participantsStarted 2012-05
Plain-language summary
The objective of this study is to evaluate the efficacy and safety of the test formulation of Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) as compared to the already marketed formulation NaftinĀ® (Naftifine HCl) 1% Cream (Merz Pharmaceuticals) and placebo in patients with tinea pedis and to show the superiority of the active treatments over placebo when dosed once a day for 28 days.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or non-pregnant, non-lactating females 18 years of age or older.
* Signed informed consent form, which meets all criteria of current FDA regulations.
* If female and of child-bearing potential, have a negative urine pregnancy test at baseline visit, and prepare to abstain from sexual intercourse or use a reliable method of contraception during the study.
* A total score of at least 4 for the clinical signs and symptoms of tinea pedis for the target lesion. In addition, the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for scaling.
* A confirmed clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot.
* The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic 10% potassium hydroxide wet mount examination.
Exclusion Criteria:
* Females who are pregnant, lactating or likely to become pregnant during the study.
* Use of antipruritics, including antihistamines within 72 hours prior to baseline visit.
* Use of topical corticosteroids, antibiotics or antifungal therapies within 2 weeks prior to baseline visit.
* Use of systemic corticosteroids, antibiotics or antifungal therapies within 1 month prior to baseline visit.
* Use of oral terbinafine or itraconazole within 2 months prior to baseline visit.
* Use of immunosuppressive medicationā¦