Tinea PedisPhase 2NCT03135912
Three-Arm Trial of Novel Treatment for Tinea Pedis
A Phase 2 study testing Experimental Drug SESC 01 and Terbinafine Hydrochloride in people with Tinea Pedis, run by South End Skin Care at 1 site in United States.
Trial summary
This is a three-arm randomized controlled trial to assess the efficacy of an experimental treatment in the treatment of tinea pedis (athlete's foot). The experimental treatment will be tested against a vehicle control to determine efficacy and safety, and against an active comparator to evaluate the success of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinea Pedis
- What is being tested?
- Experimental Drug SESC 01 and Terbinafine Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2017to 2 Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female, aged 18 or above
- clinical diagnosis of tinea pedis
- diagnosis confirmed with potassium hydroxide microscopy
- availability for the duration of the study (6 weeks)
- willingness to comply with study protocol
- informed consent
Who cannot join
- moccasin-type tinea pedis
- severe maceration of interdigital spaces
- severe fissuring
- history of dry feet, cracking, fissuring
- concurrent onychomycosis
- serous exudate or pus
Show all 12Show fewer
- topical antifungal treatment in the past 2 weeks
- systemic antifungal treatment in the past 4 weeks
- concurrent immunosuppressive or antimicrobial therapy
- liver disease
- pregnancy or breastfeeding
- known hypersensitivity to any ingredients of trial agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Kuchnir Dermatology & Dermatologic Surgery
Milford, Massachusetts, 01757
About this study
This is a three-arm randomized controlled trial to assess the efficacy of an experimental treatment in the treatment of tinea pedis (athlete's foot). The experimental treatment will be tested against a vehicle control to determine efficacy and safety, and against an active comparator to evaluate the success of the treatment relative to an existing gold-standard treatment. Patients will be treated for four weeks, with their condition being assessed at the end of treatment and two weeks after the end of treatment. The primary endpoint for this study is effective treatment rate at the week 6 evaluation, defined as a mycological cure and minimal clinical signs \& symptoms. Secondary endpoints include safety and patient evaluation of treatment.
- Conditions
- Tinea Pedis
- Being tested
- Experimental Drug SESC 01, Placebo, Terbinafine Hydrochloride
- Keywords
- Tinea Pedis, Athlete's Foot
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Drug SESC 01Drug
Topical experimental treatment comprising a combination of approved topical therapies and a new dosage method.
PlaceboDrug
Dosage method of SESC 01, without active ingredients.
Terbinafine HydrochlorideDrug
Also called Lamisil AT
Topical terbinafine hydrochloride cream.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment | Experimental | Patients supplied with Experimental Drug SESC 01 for daily topical therapy for 4 weeks. Receives: Drug: Experimental Drug SESC 01 |
| Vehicle Control | Placebo comparator | Patients supplied with inactive vehicle (placebo), identical to experimental treatment but without active ingredients, to be applied daily for 4 weeks. Receives: Drug: Placebo |
| Active Comparator | Active comparator | Terbinafine hydrochloride cream, to be applied twice daily for 4 weeks. Receives: Drug: Terbinafine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective Treatment (Mycological Cure and Minimal Symptoms)
Binary outcome measure defined as mycological cure AND a total clinical assessment score less than or equal to 2 (out of a possible 18). Mycological cure is defined as negative potassium hydroxide microscopy, while the clinical assessment is based on a sum of 6 symptoms (desquamation, vesiculation, erythema, fissuring, maceration, and pruritus) scored 0-3 by a physician.
Measured: 6 weeks
Secondary outcomes (4)
Rate of Adverse Events
To examine treatment safety, we will calculate the rate of adverse events and serious adverse and compare them between the study's three arms using Chi-square tests to evaluate whether a statistically significant difference is present.
Measured: 6 weeks
Effective Treatment (Mycological Cure and Minimal Symptoms)
Effective treatment as defined above, but measured at the end of treatment (4 weeks after the beginning of participation).
Measured: 4 weeks
Patient Satisfaction Score
At the conclusion of treatment, patients complete a brief survey on their impressions of the treatment's tolerability, effectiveness, and convenience on a five-point scale, where 1 = poor, 2 = fair, 3 = good, 4 = very good, 5 = excellent, or they may answer with "No answer/prefer not to say". Scores will be compared for each of the three characteristics and as a sum of the three scores.
Measured: 4 weeks
Self-Reported Patient Compliance
On the same experience questionnaire, patients are asked to estimate how many doses of treatment they missed or forgot to take. Possible answers are None, 1-2, 3-4, 5-6, 7-8, or 9 or more. This indicates whether there is a significant difference in patients' likelihood to adhere to a treatment regimen.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start3 Jan 2017
- Primary completion2 Aug 2017
- Study completion2 Aug 2017
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- South End Skin Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl Schanbacher, MD, Principal investigator, South End Skin Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135912
- Sponsor's protocol ID
- SESK-001
- Status last verified
- Oct 2017
- First submitted
- 20 Dec 2016
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-Arm Trial of Novel Treatment for Tinea Pedis
- ClinicalTrials.gov ID
- NCT03135912
- Acronym / sponsor ID
- SESK-001
- Conditions
- Tinea Pedis
- Keywords
- Tinea Pedis, Athlete's Foot
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- South End Skin CareIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 2 Aug 2017 (actual)
- Study completion
- 2 Aug 2017 (actual)
- First posted
- 2 May 2017 (actual)
- 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.
This is a three-arm randomized controlled trial to assess the efficacy of an experimental treatment in the treatment of tinea pedis (athlete's foot). The experimental treatment will be tested against a vehicle control to determine efficacy and safety, and against an active comparator to evaluate the success of the treatment relative to an existing gold-standard treatment. Patients will be treated for four weeks, with their condition being assessed at the end of treatment and two weeks after the end of treatment. The primary endpoint for this study is effective treatment rate at the week 6 evaluation, defined as a mycological cure and minimal clinical signs \& symptoms. Secondary endpoints include safety and patient evaluation of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment | Experimental | Drug: Experimental Drug SESC 01Patients supplied with Experimental Drug SESC 01 for daily topical therapy for 4 weeks. |
| Vehicle Control | Placebo comparator | Drug: PlaceboPatients supplied with inactive vehicle (placebo), identical to experimental treatment but without active ingredients, to be applied daily for 4 weeks. |
| Active Comparator | Active comparator | Drug: Terbinafine HydrochlorideTerbinafine hydrochloride cream, to be applied twice daily for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male or female, aged 18 or above
- clinical diagnosis of tinea pedis
- diagnosis confirmed with potassium hydroxide microscopy
- availability for the duration of the study (6 weeks)
- willingness to comply with study protocol
Key exclusion criteria (12 listed)
- moccasin-type tinea pedis
- severe maceration of interdigital spaces
- severe fissuring
- history of dry feet, cracking, fissuring
- concurrent onychomycosis
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 |
|---|---|---|
| Experimental Drug SESC 01Topical experimental treatment comprising a combination of approved topical therapies and a new dosage method. | Drug | Experimental Treatment |
| PlaceboDosage method of SESC 01, without active ingredients. | Drug | Vehicle Control |
| Terbinafine HydrochlorideAlso: Lamisil ATTopical terbinafine hydrochloride cream. | Drug | Active Comparator |
Primary outcome
Effective Treatment (Mycological Cure and Minimal Symptoms)
Time frame: 6 weeks
Binary outcome measure defined as mycological cure AND a total clinical assessment score less than or equal to 2 (out of a possible 18). Mycological cure is defined as negative potassium hydroxide microscopy, while the clinical assessment is based on a sum of 6 symptoms (desquamation, vesiculation, erythema, fissuring, maceration, and pruritus) scored 0-3 by a physician.
4 secondary outcomes
Rate of Adverse Events
Time frame: 6 weeks
Effective Treatment (Mycological Cure and Minimal Symptoms)
Time frame: 4 weeks
Patient Satisfaction Score
Time frame: 4 weeks
Self-Reported Patient Compliance
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
Related trials for Tinea Pedis
RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
RecruitingPhase 1
A Phase 1b Study of ZYG24004 in Participants With Tinea Pedis Caused by Dermatophytes
Tinea Pedis
Recruiting
Atmospheric Pressure Cold Plasma for Moderate-to-severe Tinea Pedis
Tinea Pedis
RecruitingPhase 2
Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study
Tinea Pedis
Not yet recruitingObservational study
Sports Nutrition Assessment Program
Diet Habit, Body Weight
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.
Carl Schanbacher, MD principal investigator
South End Skin Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Experimental Drug SESC 01 and Terbinafine Hydrochloride in people with Tinea Pedis, run by South End Skin Care at 1 site 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effective Treatment (Mycological Cure and Minimal Symptoms) (time frame: 6 weeks). 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 6 Oct 2017.