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TerminatedNCT02842021Updated Nov 18, 2020

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

A Phase 2 interventional study of S2G6T-1 and S2G6T-2 in Tinea Pedis, sponsored by Sol-Gel Technologies, Ltd.. Terminated at 19 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2020-11-18.

Sponsored by Sol-Gel Technologies, Ltd. · Phase 2, Interventional, and Treatment

Why this study was terminated
Failed to meet success criteria
Phase
Phase 2
Study type
Interventional
Enrollment
283
Allocation
Randomized
Ages
12 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Tinea Pedis

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03

In context

Tinea Pedis

73 studies on the registry are indexed under Tinea Pedis; 8 are open to participants now.

This study's enrollment of 283 is above the median of 128 across 66 interventional studies indexed under Tinea Pedis.

Browse Tinea Pedis studies →

Lead sponsor

Sol-Gel Technologies, Ltd. is the lead sponsor of 15 studies on the registry; none are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 8 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Ability and willingness to sign a written 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 must have a negative urine pregnancy test and must agree to use an effective form of 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

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 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 (e.g., 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 , 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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Terms in these criteria, in plain language(7)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

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.

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.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
283 participants (actual)

Study arms

  • Active comparator
    S2G6T-1

    Topical cream

    Drug: S2G6T-1

  • Active comparator
    S2G6T-2

    Topical Cream

    Drug: S2G6T-2

  • Active comparator
    S2G6T-3

    Topical Cream

    Drug: S2G6T-3

  • Placebo comparator
    S2G6T-4

    Topical Cream

    Drug: S2G6T-4

Interventions

  • DrugS2G6T-1

    Twice a day topical cream

  • DrugS2G6T-2

    Twice a day topical cream

  • DrugS2G6T-3

    Twice a day topical cream

  • DrugS2G6T-4

    Twice a day topical cream

06

What researchers measure

Primary outcomes

  1. Complete cure at Day 29

    The primary efficacy comparison between S2G6T-1 vs. rest of study arms will be based on the percentage of subjects at day 29 with complete cure of interdigital tinea pedis.mycological cure (i.e. negative dermatophyte culture and negative KOH) and clinical cure (i.e. absence of erythema, scaling and pruritus {scores of 0, each})

    Time frame: Day 29

  2. Reduction in Tinea pedis SymptomS through treatment period.

    comparison of Patient Assessment between S2G6T-1 vs. rest of study arms will be based on the percentage of subjects at day 8 with achieving decrease from baseline in the total score for pruritus and burning.

    Time frame: Day 8

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Study locations

19 sites
  • TCR Medical Corporation
    San Diego, California 92123, United States
  • University Clinical Trials, Inc.
    San Diego, California 92123, United States
  • Tampa Bay Medical Research
    Clearwater, Florida 33761, United States
  • Tory Sullivan, MD, PA
    North Miami Beach, Florida 33162, United States
  • Park Avenue Dermatology
    Orange Park, Florida 32073, United States
  • Mid Atlantic Research for Health
    Baltimore, Maryland 21214, United States
  • Minnesota Clinical Study Center
    Fridley, Minnesota 55432, United States
  • Academic Dermatology Associates
    Albuquerque, New Mexico 87106, United States
  • Skin Search of Rochester, Inc.
    Rochester, New York 146232, United States
  • Tennessee Clinical Research Center
    Nashville, Tennessee 37215, United States
  • DermResearch, Inc.
    Austin, Texas 78759, United States
  • J&S Studies, Inc
    College Station, Texas 77845, United States
  • Suzanne Bruce & Associates, PA / The Center for Skin Research
    Houston, Texas 77056, United States
  • Suzanne Bruce & Associates ,PA / The Center for Skin Research
    Katy, Texas 77494, United States
  • DermResearch New Braunfels
    New Braunfels, Texas 78130, United States
  • Endeavor Clinical Trials, PA
    San Antonio, Texas 78229, United States
  • Dermatology Research Center, Inc.
    Salt Lake City, Utah 84117, United States
  • The Education & Research Foundation Inc.
    Lynchburg, Virginia 24501, United States
  • Virginia Clinical Research Inc.
    Norfolk, Virginia 23502, United States
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02842021
Lead sponsor
Sol-Gel Technologies, Ltd.
Responsible party
Sponsor
First posted
Jul 22, 2016
Start date
Sep 2016
Primary completion
Oct 2017
Completion
Oct 2017
Last update
Nov 18, 2020

Study contacts

Kathleen O Ashenfelter, MS
study chair · Cu-Tech, LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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