Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis



Status:Completed
Conditions:Podiatry
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:May 2012
End Date:June 2013
Contact:Taro Pharmaceuticals
Phone:914-345-9001

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Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design Study to Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis.


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 Naftin® (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.


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% KOH 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 medication or radiation therapy within 3 months prior to
baseline visit.

- Any known hypersensitivity to Naftifine HCl, any component of the formulation or
other antifungal agents.

- Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.

- Significant history or current evidence of chronic infectious disease, system
disorder, organ disorder, or other medical condition that would place the patient at
undue risk by participation or could jeopardize the integrity of the study
evaluations.

- Evidence of any concurrent dermatophytic infection of the toe nails or dermatological
condition of the foot that may interfere with the evaluation of tinea pedis.

- Patients with a past history of tinea pedis infections with a lack of response to
antifungal therapy.

- Patients who would be non-compliant with the requirements of the study protocol.

- Participation in a research study within 30 days prior to baseline visit.

- Employees or family members of employees of the research center or investigator.

- Previous participation in this study.
We found this trial at
30
sites
Hickory, North Carolina 28602
2069
mi
from 91732
Hickory, NC
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980 Johnson Ferry Road
Atlanta, Georgia 30342
770-507-6867
1919
mi
from 91732
Atlanta, GA
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8042 Wurzbach Road
San Antonio, Texas 78229
210-949-0807
1181
mi
from 91732
San Antonio, TX
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Albuquerque, New Mexico
649
mi
from 91732
Albuquerque, NM
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1932
mi
from 91732
Ann Arbor, MI
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Baltimore, Maryland 21214
2301
mi
from 91732
Baltimore, MD
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2013
mi
from 91732
Bristol, TN
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Bristol, Tennessee 37620
2013
mi
from 91732
Bristol, TN
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College Station, Texas 77845
1288
mi
from 91732
College Station, TX
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2187
mi
from 91732
Daytona Beach, FL
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327
mi
from 91732
Freemont, CA
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Hialeah, Florida 33012
2313
mi
from 91732
Hialeah, FL
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High Point, North Carolina 27262
2140
mi
from 91732
High Point, NC
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Las Vegas, Nevada 89119
214
mi
from 91732
Las Vegas, NV
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Miami, Florida 33175
2320
mi
from 91732
Miami, FL
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Miami, Florida 33175
2320
mi
from 91732
Miami, FL
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Miami, Florida 33015
2310
mi
from 91732
Miami, FL
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Nashville, Tennessee 37215
1763
mi
from 91732
Nashville, TN
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Newport News, Virginia 23606
2323
mi
from 91732
Newport News, VA
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Omaha, Nebraska 68134
1295
mi
from 91732
Omaha, NE
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2186
mi
from 91732
Ormond Beach, FL
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2119
mi
from 91732
Pittsburgh, PA
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Plainfield, Indiana 46168
1780
mi
from 91732
Plainfield, IN
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Salisbury, North Carolina 28144
2118
mi
from 91732
Salisbury, NC
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San Diego, California 92108
103
mi
from 91732
San Diego, CA
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316
mi
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Santa Clara, CA
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Spanish Fork, Utah 84660
544
mi
from 91732
Spanish Fork, UT
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Stockbridge, Georgia 30281
1930
mi
from 91732
Stockbridge, GA
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Towson, Maryland 21204
2301
mi
from 91732
Towson, MD
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Upper St. Clair, Pennsylvania 15241
2115
mi
from 91732
Upper St. Clair, PA
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