Efficacy and Safety of Product S2G6T-1in Patients With Symptomatic Inflammatory Interdigital Tinea Pedis



Status:Completed
Conditions:Podiatry
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:12 - Any
Updated:10/6/2017
Start Date:September 2016
End Date:October 2017

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A Randomized, Double-Blind, Active- and Vehicle-Controlled Study to Compare the Efficacy and Safety of Products S2G6T-1, S2G6T-2, S2G6T-3 and S2G6T-4 in Patients With Symptomatic Inflammatory Interdigital Tinea Pedis

To assess the efficacy and safety of a combination product S2G6T-1 compared to its monads and
vehicle, applied twice daily for 7 days, in the treatment of symptomatic inflammatory
interdigital tinea pedis in subjects 12 years of age and older. The results of this study
will be utilized to perform power calculations for the Phase 3 pivotal trials.


Inclusion Criteria:

1. Ability and willingness to sign a written informed consent and /or assent (age
appropriate).

2. Male or Female subjects 12 years of age or older.

3. A clinical diagnosis of interdigital tinea pedis on one or both feet characterized by
clinical evidence of a tinea infection.

4. A sum of at least five (5) for signs (erythema and scaling) by the investigator on the
selected target foot, and a score of at least five (5) for each symptom: pruritus
(itching) and burning: and a sum of at least twelve (12) for both symptoms (pruritus
and burning) by the subject on the PATSS.

5. Mycological evidence of the presence of fungi confirmed by the detection of fungal
hyphae on a microscopic KOH wet mount.

6. Females of child-bearing potential must have a negative urine pregnancy test and must
agree to use an effective form of contraception during the study .

7. Must be in good general health as determined by medical history and free of any
disease that in the investigator's opinion might interfere with the study evaluations.

8. Must be able to communicate, be able to understand the study procedures, and be
willing to comply with the study requirements.

Exclusion Criteria:

1. The presence of confluent diffuse moccasin-type tinea pedis.

2. Negative KOH microscopy test to assess presence of hyphae.

3. Onychomycosis of the toenails, involving ≥ 20% of the area of either great toenail or
involvement of more than five toenails in total.

4. Concurrent tinea infection or bacterial skin infection on the feet.

5. Female subjects who are pregnant and/or nursing or planning a pregnancy during the
course of the trial.

6. Recent history of or currently known to abuse drugs or alcohol.

7. History of intolerance or hypersensitivity to Econazole Nitrate, Mometasone Furoate,
or other imidazole agents.

8. Presence of any other infection of the foot or other disease process that might
confound the treatment evaluation.

9. Having a life-threatening condition or immunocompromised (e.g., autoimmune deficiency
syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months.

10. Unable to communicate or cooperate with the investigator due to language barriers,
poor mental development, or impaired cerebral function.

11. Current participation in a clinical drug research study or recent participation in a
clinical trial within 30 days of Baseline.

12. Using the following medications prior to Baseline:

1. Antipruritics, including antihistamines within 3 days (72 hours).

2. Topical corticosteroids, antibiotics or antifungal therapies within 4 weeks.

3. Systemic corticosteroids, antibiotics or antifungal therapies within 12 weeks.

4. Oral terbinafine or itraconazole within 12 weeks.

5. Immunosuppressive medication or radiation therapy within 12 weeks.

6. Any other topical medicated topical treatments to the treatment area(s) within 7
days.
We found this trial at
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Fridley, Minnesota 55432
Principal Investigator: Steven Kempers, MD
Phone: 763-571-4200
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2095 Langhorne Road
Lynchburg, Virginia 24501
434-847-8400
Principal Investigator: David C. Wilson, MD
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8042 Wurzbach Road
San Antonio, Texas 78229
210-949-0807
Principal Investigator: Richard Pollak, DPM, MS
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Albuquerque, New Mexico 87106
Principal Investigator: Alicia D Bucko, DO, JD
Phone: 505-247-4220
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Austin, Texas 78759
Principal Investigator: Janet C DuBois, MD
Phone: 512-349-9889
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5508 Harford Road
Baltimore, Maryland 21214
Principal Investigator: Max Weisfeld, DPM
Phone: 443-686-0012
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Clearwater, Florida 33761
Principal Investigator: Srikanth Malempati, MD
Phone: 727-724-3316
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College Station, Texas 77845
Phone: 979-774-5933
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Houston, Texas 77056
Principal Investigator: Tracy Katz, MD
Phone: 713-985-0210
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Katy, Texas 77494
Principal Investigator: Suzanne Bruce, MD
Phone: 713-985-0210
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Nashville, Tennessee 37215
Principal Investigator: Michael H Gold, MD
Phone: 615-383-9660
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8140 North Mopac Expressway
New Braunfels, Texas 78130
Principal Investigator: Vicente Quintero, MD
Phone: 830-387-5768
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Norfolk, Virginia 23507
Principal Investigator: David M. Pariser, MD
Phone: 757-625-0151
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North Miami Beach, Florida 33162
Principal Investigator: Tory Sullivan, MD
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Orange Park, Florida 32073
Principal Investigator: George Schmieder, Do
Phone: 904-458-0411
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Rochester, New York 14623
Principal Investigator: John H. Tu, MD
Phone: 585-697-1818
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Salt Lake City, Utah 84124
Principal Investigator: Leonard J. Swinyer, MD
Phone: 801-269-0135
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San Diego, California 92123
Principal Investigator: Neal D Bhatia, MD
Phone: 858-571-6800
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San Diego, California 92123
Principal Investigator: Walter Nahm, PhD., MD.
Phone: 858-278-8470
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