Clinical trial NCT02842021: Efficacy and Safety of Product S2G6T-1in Patients With Symptomatic Inflammatory Interdigital Tinea Pedis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Tinea Pedis
Lead sponsor: Sol-Gel Technologies, Ltd.
Sponsor class: INDUSTRY
First posted: 2016-07-22
Enrollment: 283
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

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Primary outcomes:
measure: Complete cure at Day 29
timeFrame: Day 29
measure: Reduction in Tinea pedis SymptomS through treatment period.
timeFrame: Day 8
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: TCR Medical Corporation
state: California
city: San Diego
country: United States
facility: University Clinical Trials, Inc.
state: California
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: North Miami Beach
country: United States
facility: Tory Sullivan, MD, PA
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: Baltimore
country: United States
facility: Mid Atlantic Research for Health
state: Maryland
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc.
state: New York
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: College Station
country: United States
facility: J&S Studies, Inc
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce & Associates, PA / The Center for Skin Research
state: Texas
city: Katy
country: United States
facility: Suzanne Bruce & Associates ,PA / The Center for Skin Research
state: Texas
city: New Braunfels
country: United States
facility: DermResearch New Braunfels
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials, PA
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center, Inc.
state: Utah
city: Lynchburg
country: United States
facility: The Education & Research Foundation Inc.
state: Virginia
city: Norfolk
country: United States
facility: Virginia Clinical Research Inc.
state: Virginia
Study officials:
affiliation: Cu-Tech, LLC
name: Kathleen O Ashenfelter, MS
role: STUDY_CHAIR
References: