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
Las Vegas, Nevada 89119
961
mi
from
Las Vegas, NV
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980 Johnson Ferry Road
Atlanta, Georgia 30342
770-507-6867
798
mi
from
Atlanta, GA
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8042 Wurzbach Road
San Antonio, Texas 78229
210-949-0807
570
mi
from
San Antonio, TX
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Albuquerque, New Mexico
523
mi
from
Albuquerque, NM
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808
mi
from
Ann Arbor, MI
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Baltimore, Maryland 21214
1148
mi
from
Baltimore, MD
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861
mi
from
Bristol, TN
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Bristol, Tennessee 37620
861
mi
from
Bristol, TN
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College Station, Texas 77845
503
mi
from
College Station, TX
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1128
mi
from
Daytona Beach, FL
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1317
mi
from
Freemont, CA
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Hialeah, Florida 33012
1312
mi
from
Hialeah, FL
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Hickory, North Carolina 28602
922
mi
from
Hickory, NC
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High Point, North Carolina 27262
990
mi
from
High Point, NC
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Miami, Florida 33175
1321
mi
from
Miami, FL
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Miami, Florida 33175
1321
mi
from
Miami, FL
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Miami, Florida 33015
1308
mi
from
Miami, FL
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Nashville, Tennessee 37215
619
mi
from
Nashville, TN
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Newport News, Virginia 23606
1168
mi
from
Newport News, VA
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Omaha, Nebraska 68134
262
mi
from
Omaha, NE
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1126
mi
from
Ormond Beach, FL
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971
mi
from
Pittsburgh, PA
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Plainfield, Indiana 46168
629
mi
from
Plainfield, IN
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Salisbury, North Carolina 28144
970
mi
from
Salisbury, NC
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San Diego, California 92108
1140
mi
from
San Diego, CA
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1318
mi
from
Santa Clara, CA
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Spanish Fork, Utah 84660
760
mi
from
Spanish Fork, UT
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Stockbridge, Georgia 30281
815
mi
from
Stockbridge, GA
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Towson, Maryland 21204
1148
mi
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Towson, MD
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Upper St. Clair, Pennsylvania 15241
967
mi
from
Upper St. Clair, PA
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