A Phase 3 interventional study of Naftifine hydrochloride 2% and Placebo in Tinea Pedis, sponsored by Genzum Life Sciences. Completed at 14 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-11.
Sponsored by Genzum Life Sciences · Phase 3, Interventional, and Treatment
The current study was randomized, double blind, placebo-controlled, prospective, multicenter, comparative therapeutic equivalence study.
The study duration for each patient was 6 weeks: Following were the visit details.
V1-Baseline and Randomization Visit (Day 1). V2- End of therapy visit (at the end of week 2 + 2 days). V3- Follow up visit (at the end of week 4 + 2 days). V4 - Test of cure visit ( at the end of week 6 + 4 days).
73 studies on the registry are indexed under Tinea Pedis; 8 are open to participants now.
This study's enrollment of 693 is above the median of 128 across 66 interventional studies indexed under Tinea Pedis.
Browse Tinea Pedis studies →This is the only study on the registry with Genzum Life Sciences as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A thin layer of sufficient quantity of Naftifine hydrochloride cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks.
Drug: Naftifine hydrochloride 2%
A thin layer of sufficient quantity of Naftifine hydrochloride cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks.
Drug: Naftin® 2% (Naftifine hydrochloride 2%)
A thin layer of sufficient quantity of vehicle cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks.
Drug: Placebo
Topical application for two weeks
Also known as: Naftifine hcl
Topical application for two weeks
Also known as: Vehicle cream
Topical application for two weeks
Also known as: Naftifine hcl
Mycological cure and clinical cure for a single target lesion for Trichyphyton rubrum
After 6 weeks the skin scrapping will be collected for culture to find out the growth of T rubrum. Absence of growth suggests complete cure.
Time frame: week 6 + 4 days
Mycological cure and clinical cure for Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum
After 6 weeks the skin scrapping will be collected for culture to find out the growth of T rubrum, T Mentagrophytes or E floccosum. Absence of growth suggests complete cure.
Time frame: week 6 + 4 days
Assessment of AEs for each treatment groups
number of adverse events reported will be collated from all the treatment arms, to evaluate the safety of the study drugs.
Time frame: week 6 + 4 days
Plan to share: Undecided
No publications or documents are linked to this record.
The record gives a start of Mar 2015, a primary completion of Nov 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Naftifine