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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02842021
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Sol-Gel Technologies, Ltd.

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.

Condition or disease Intervention/treatment Phase
Tinea Pedis Drug: S2G6T-1 Drug: S2G6T-2 Drug: S2G6T-3 Drug: S2G6T-4 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017


Arm Intervention/treatment
Active Comparator: S2G6T-1
Topical cream
Drug: S2G6T-1
Twice a day topical cream

Active Comparator: S2G6T-2
Topical Cream
Drug: S2G6T-2
Twice a day topical cream

Active Comparator: S2G6T-3
Topical Cream
Drug: S2G6T-3
Twice a day topical cream

Placebo Comparator: S2G6T-4
Topical Cream
Drug: S2G6T-4
Twice a day topical cream




Primary Outcome Measures :
  1. Complete cure at Day 29 [ Time Frame: 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})

  2. Reduction in Tinea pedis SymptomS through treatment period. [ Time Frame: Day 8 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842021


Locations
Show Show 19 study locations
Sponsors and Collaborators
Sol-Gel Technologies, Ltd.
Investigators
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Study Chair: Kathleen O Ashenfelter, MS Cu-Tech, LLC
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Responsible Party: Sol-Gel Technologies, Ltd.
ClinicalTrials.gov Identifier: NCT02842021    
Other Study ID Numbers: SGT-26-01
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Tinea
Tinea Pedis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Signs and Symptoms