Tinea PedisPhase 2NCT02842021
Efficacy and Safety of Product S2G6T-1in Patients With Symptomatic Inflammatory Interdigital Tinea Pedis
A Phase 2 study testing S2G6T-1, S2G6T-2 and S2G6T-3 in people with Tinea Pedis, run by Sol-Gel Technologies, Ltd. at 19 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Tinea Pedis
- What is being tested?
- S2G6T-1, S2G6T-2 and S2G6T-3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 283 participants
- Where
- 19 sitesUnited States
- Study dates
- Sep 2016to Oct 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ability and willingness to sign a written informed consent and /or assent (age appropriate).
- Male or Female subjects 12 years of age or older.
- A clinical diagnosis of interdigital tinea pedis on one or both feet characterized by clinical evidence of a tinea infection.
- 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.
- Mycological evidence of the presence of fungi confirmed by the detection of fungal hyphae on a microscopic KOH wet mount.
- 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 .
- 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.
- Must be able to communicate, be able to understand the study procedures, and be willing to comply with the study requirements.
Who cannot join
- The presence of confluent diffuse moccasin-type tinea pedis.
- Negative KOH microscopy test to assess presence of hyphae.
- Onychomycosis of the toenails, involving ≥ 20% of the area of either great toenail or involvement of more than five toenails in total.
- Concurrent tinea infection or bacterial skin infection on the feet.
- Female subjects who are pregnant and/or nursing or planning a pregnancy during the course of the trial.
- Recent history of or currently known to abuse drugs or alcohol.
Show all 19Show fewer
- History of intolerance or hypersensitivity to Econazole Nitrate, Mometasone Furoate, or other imidazole agents.
- Presence of any other infection of the foot or other disease process that might confound the treatment evaluation.
- Having a life-threatening condition or immunocompromised (e.g., autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months.
- Unable to communicate or cooperate with the investigator due to language barriers, poor mental development, or impaired cerebral function.
- Current participation in a clinical drug research study or recent participation in a clinical trial within 30 days of Baseline.
- Using the following medications prior to Baseline:
- Antipruritics, including antihistamines within 3 days (72 hours).
- Topical corticosteroids, antibiotics or antifungal therapies within 4 weeks.
- Systemic corticosteroids, antibiotics or antifungal therapies within 12 weeks.
- Oral terbinafine or itraconazole within 12 weeks.
- Immunosuppressive medication or radiation therapy within 12 weeks.
- Any other topical medicated topical treatments to the treatment area(s) within 7 days.
- -
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
DermResearch, Inc.
Austin, Texas, 78759
Mid Atlantic Research for Health
Baltimore, Maryland, 21214
Tampa Bay Medical Research
Clearwater, Florida, 33761
J&S Studies, Inc
College Station, Texas, 77845
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Suzanne Bruce & Associates, PA / The Center for Skin Research
Houston, Texas, 77056
Suzanne Bruce & Associates ,PA / The Center for Skin Research
Katy, Texas, 77494
The Education & Research Foundation Inc.
Lynchburg, Virginia, 24501
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
DermResearch New Braunfels
New Braunfels, Texas, 78130
Virginia Clinical Research Inc.
Norfolk, Virginia, 23502
Tory Sullivan, MD, PA
North Miami Beach, Florida, 33162
Park Avenue Dermatology
Orange Park, Florida, 32073
Skin Search of Rochester, Inc.
Rochester, New York, 146232
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84117
Endeavor Clinical Trials, PA
San Antonio, Texas, 78229
TCR Medical Corporation
San Diego, California, 92123
University Clinical Trials, Inc.
San Diego, California, 92123
About this study
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
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.
- Conditions
- Tinea Pedis
- Being tested
- S2G6T-1, S2G6T-2, S2G6T-3, S2G6T-4
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S2G6T-1Drug
Twice a day topical cream
S2G6T-2Drug
Twice a day topical cream
S2G6T-3Drug
Twice a day topical cream
S2G6T-4Drug
Twice a day topical cream
| Study group | Role | What they receive |
|---|---|---|
| S2G6T-1 | Active comparator | Topical cream Receives: Drug: S2G6T-1 |
| S2G6T-2 | Active comparator | Topical Cream Receives: Drug: S2G6T-2 |
| S2G6T-3 | Active comparator | Topical Cream Receives: Drug: S2G6T-3 |
| S2G6T-4 | Placebo comparator | Topical Cream Receives: Drug: S2G6T-4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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})
Measured: Day 29
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.
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2017
- Study completionOct 2017
Why it stopped: Failed to meet success criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinea PedisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sol-Gel Technologies, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathleen O Ashenfelter, MS, Study chair, Cu-Tech, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842021
- Sponsor's protocol ID
- SGT-26-01
- Status last verified
- Nov 2020
- First submitted
- 13 Jul 2016
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02842021
- Acronym / sponsor ID
- SGT-26-01
- Conditions
- Tinea Pedis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failed to meet success criteria
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Sol-Gel Technologies, Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| S2G6T-1 | Active comparator | Drug: S2G6T-1Topical cream |
| S2G6T-2 | Active comparator | Drug: S2G6T-2Topical Cream |
| S2G6T-3 | Active comparator | Drug: S2G6T-3Topical Cream |
| S2G6T-4 | Placebo comparator | Drug: S2G6T-4Topical Cream |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Ability and willingness to sign a written informed consent and /or assent (age appropriate).
- Male or Female subjects 12 years of age or older.
- A clinical diagnosis of interdigital tinea pedis on one or both feet characterized by clinical evidence of a tinea infection.
- 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.
- Mycological evidence of the presence of fungi confirmed by the detection of fungal hyphae on a microscopic KOH wet mount.
Key exclusion criteria (19 listed)
- The presence of confluent diffuse moccasin-type tinea pedis.
- Negative KOH microscopy test to assess presence of hyphae.
- Onychomycosis of the toenails, involving ≥ 20% of the area of either great toenail or involvement of more than five toenails in total.
- Concurrent tinea infection or bacterial skin infection on the feet.
- Female subjects who are pregnant and/or nursing or planning a pregnancy during the course of the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S2G6T-1Twice a day topical cream | Drug | S2G6T-1 |
| S2G6T-2Twice a day topical cream | Drug | S2G6T-2 |
| S2G6T-3Twice a day topical cream | Drug | S2G6T-3 |
| S2G6T-4Twice a day topical cream | Drug | S2G6T-4 |
Primary outcome
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})
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.
Results and safety
The study was stopped early (reason given: Failed to meet success criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen O Ashenfelter, MS study chair
Cu-Tech, LLC
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S2G6T-1, S2G6T-2 and S2G6T-3 in people with Tinea Pedis, run by Sol-Gel Technologies, Ltd. at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Failed to meet success criteria). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete cure at Day 29 (time frame: Day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.