A Phase 1 interventional study of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis, sponsored by Taro Pharmaceuticals USA. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-06.
Sponsored by Taro Pharmaceuticals USA (part of Sun Pharmaceutical Industries Limited) · Phase 1, Interventional, and Treatment
To compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2%
The purpose of this study is to compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2% in a six week study (four weeks after the end of two week treatment) in patients with tinea pedis.
73 studies on the registry are indexed under Tinea Pedis; 8 are open to participants now.
This study's enrollment of 1,519 is above the median of 128 across 66 interventional studies indexed under Tinea Pedis.
Browse Tinea Pedis studies →Taro Pharmaceuticals USA is the lead sponsor of 71 studies on the registry; none are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 1 (5%) have results posted.
First submitted after Taro Pharmaceuticals USA became part of Sun Pharmaceutical Industries Limited.
Counted across the registry records on this site, refreshed daily.
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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.
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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.
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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.
Naftifine Hydrochloride Gel 2% (Taro Pharmaceuticals Inc.)
Drug: Naftifine Hydrochloride Gel 2%
Naftin® (Naftifine Hydrochloride) Gel 2% (Merz Pharmaceuticals, LLC)
Drug: Naftin® Gel 2%
Placebo Topical Gel (Taro Pharmaceuticals Inc.)
Drug: Placebo Topical Gel
Naftifine Hydrochloride Gel 2% applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.
Also known as: Naftifine
Naftin® Gel 2% applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.
Also known as: Naftifine
Placebo Topical Gel applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.
Also known as: Vehicle
Therapeutic cure after end of treatment
The proportion of subjects with therapeutic cure, defined as both mycological cure and clinical cure, at the test-of-cure visit conducted four weeks after the end of treatment (study day 38-46).
Time frame: Study day 38-46
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Naftifine