Tinea PedisPhase 3NCT03824912
Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis
A Phase 3 study testing Ketoconazole Cream 2% and Ketoconazole Cream 2% (G&W Laboratories Inc.) in people with Tinea Pedis, run by Encube Ethicals Pvt. Ltd. at 9 sites in 3 countries.
Trial summary
Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis 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?
- Ketoconazole Cream 2% and Ketoconazole Cream 2% (G&W Laboratories Inc.)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 831 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 23 Aug 2018to 24 Jan 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy male or non-pregnant, non-lactating female, ≥ 18 years of age.
- Signed informed consent form (ICF) that meets all criteria of current Food and Drug Administration regulations.
- Female patient of childbearing potential must not be pregnant or lactating at Visit 1 (as confirmed by a negative urine pregnancy test with a sensitivity of less than 50 milli-International unit (mIU/mL) or equivalent units of human chorionic gonadotropin).
- Female patient of childbearing potential must agree to the use of a reliable method of contraception throughout the study (e.g., total abstinence, intrauterine device, a double-barrier method, oral, transdermal, injected, or implanted non-hormonal or hormonal contraceptive) throughout the study. A sterile sexual partner is not considered an adequate form of birth control. If the female is using any estrogen or oral contraceptive therapy, the same product must have been taken for at least one month before Visit 1.
- Have clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin).
- The presence of tinea pedis infection provisionally confirmed at baseline by a positive potassium hydroxide (KOH) wet mount preparation (i.e., skin scrapings from the target site are placed on a microscope slide with a drop of 10% KOH, and microscopic examination reveals segmented fungal hyphae).
Show all 9Show fewer
- The sum of clinical signs and symptoms scores of the target lesion ≥ 4. See Appendix A for scoring scale:
- Signs: Fissuring/cracking, erythema, maceration and scaling
- Symptoms: pruritus and burning/stinging In addition the target lesion must have a minimum score ≥ 2 for erythema and a minimum score ≥ 2 for either pruritus or scaling.
Who cannot join
- Females who are pregnant, lactating or planning to become pregnant during the study period.
- History of or current psoriasis, Lichen planus or contact dermatitis involving the feet within the previous 12 months.
- History of dermatophyte infections with a lack of response to antifungal therapy (recurrent tinea pedis [i.e., more than 3 infections in the past 12 months] that were unresponsive to previous antifungal therapy).
- History of allergy, hypersensitivity, or intolerance to ketoconazole, other imidazoles, sulfites or any other component of the study product.
- Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
- Current uncontrolled diabetes.
Show all 18Show fewer
- Presence of any other infection of the foot or other disease process that, in the Investigator's opinion, may interfere with the evaluation of the patient's tinea pedis.
- Known history of or current impaired wound healing, presence of peripheral vascular disease and/or trophic changes of the lower limbs to an extent that, in the opinion of the Investigator, would make the patient unsuitable for the study or compromise patient's safety.
- Significant history or current evidence of chronic infectious disease, system disorder, organ disorder, immunosuppression (due to disease or therapy, including history of organ transplant), or other medical condition that, in the Investigator's opinion, would place the patient at undue risk by participating or compromise the integrity of the study data.
- Use of antipruritics, including antihistamines, within 72 hours before Visit 1.
- Use of topical corticosteroids, topical antibiotics or topical antifungal therapy (e.g., clotrimazole, econazole, fluconazole) within 2 weeks before Visit 1.
- Use of systemic (e.g., oral or injectable) antibiotics, systemic antifungal therapy, or systemic corticosteroids within 30 days before Visit 1. The use of intranasal, inhaled or ophthalmic corticosteroids for acute or chronic conditions (e.g., allergic conjunctivitis, asthma/chronic obstructive pulmonary disease maintenance) is acceptable to the extent that, in the opinion of the Investigator, does not compromise safety of patient or integrity of data.
- Use of oral terbinafine or itraconazole within 2 months before Visit 1.
- Use of immunosuppressive medication or radiation therapy within 3 months before Visit 1.
- Receipt of any drug as part of a research study within 30 days before Visit 1.
- Previous participation in this study.
- Employee of the Investigator or research center or their immediate family members.
- Inability to understand the requirements of the study and the relative information or are unable or unwilling to comply with the study protocol.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United States7 sites
Long Beach Clinical Trial Services, Inc.
Long Beach, California, 90806
International Dermatology Research, Inc.
Miami, Florida, 33144
FXM Research Corp.
Miami, Florida, 33175
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, 33014
FXM Research Miramar
Miramar, Florida, 33027
MOORE Clinical Research, Inc.
Tampa, Florida, 33609
PEAK Research, LLC
Upper Saint Clair, Pennsylvania, 15241
Belize1 site
FXM Research International
Belize City
Saint Lucia1 site
FXM Research International
Castries
About this study
Official title: A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd) to Ketoconazole Cream 2% (G&W Laboratories Inc.) in the Treatment of Tinea Pedis
Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis
Read the detailed description
A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd) to Ketoconazole Cream 2% (G\&W Laboratories Inc.) in the Treatment of Tinea Pedis
- Conditions
- Tinea Pedis
- Being tested
- Ketoconazole Cream 2%, Ketoconazole Cream 2% (G&W Laboratories Inc.), Placebo
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketoconazole Cream 2%Drug
Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.
Ketoconazole Cream 2% (G&W Laboratories Inc.)Drug
Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.
PlaceboDrug
Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.
| Study group | Role | What they receive |
|---|---|---|
| Test: Ketoconazole Cream 2% | Experimental | Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd) Receives: Drug: Ketoconazole Cream 2% |
| Reference: Ketoconazole Cream 2% | Active comparator | Ketoconazole Cream 2% (G\&W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.) Receives: Drug: Ketoconazole Cream 2% (G&W Laboratories Inc.) |
| Placebo: Cream (Test vehicle) | Placebo comparator | Placebo Cream (Test vehicle) (Encube Ethicals Pvt Ltd) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Equivalence: Per-Protocol Population)
Equivalence: Per-Protocol Population Therapeutic Cure: To be considered a Therapeutic Cure, the patient must have both Clinical and Mycological Cure of tinea pedis.
Therapeutic Failure: A patient will be considered a Therapeutic Failure if:
- the patient is a Clinical or Mycological Failure
- the patient was considered to have an insufficient therapeutic response
- the patient used topical drug therapy for irritation or pruritus on the feet after the treatment phase of the study
Measured: Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)
Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population)
Superiority: modified Intent-to-Treat Population Therapeutic Cure: To be considered a Therapeutic Cure, the patient must have both Clinical and Mycological Cure of tinea pedis.
Therapeutic Failure: A patient will be considered a Therapeutic Failure if:
- the patient is a Clinical or Mycological Failure
- the patient was considered to have an insufficient therapeutic response
- the patient used topical drug therapy for irritation or pruritus on the feet after the treatment phase of the study
Measured: Two weeks after the end of treatment (Day 56 ± 4) (Superiority)
Secondary outcomes (4)
Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Equivalence: Per-Protocol Population)
Clinical Cure: To be considered a clinical cure the patient's total severity score must be ≤ 2 with no individual severity score > 1.
Clinical Failure: A patient will be considered a Clinical Failure if the patient's total severity score is > 2 or any individual score is > 1.
Local Signs and Symptoms The most severely affected area will be identified as the target lesion at the baseline visit and will be used for the assessments at Day 42 and Day 56 visits.
The Clinical Signs and Symptoms of tinea pedis will be rated by the Investigator as "none", "mild," "moderate" or "severe" using the following standardized rating scale.
0 = None (complete absence of any sign or symptom)
- = Mild (Slight)
- = Moderate (Definitely Present)
- = Severe (Marked, Intense)
The following signs and symptoms will be rated at each visit:
- Signs: Fissuring/cracking, erythema, maceration, and scaling
- Symptoms: Pruritus and burning/stinging
Measured: Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)
Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Equivalence: Per-Protocol Population)
Mycological Cure: To be considered a mycological cure the patient must have a negative Potassium hydroxide (KOH) test and a negative fungal culture.
Mycological Failure: A patient will be considered a Mycological Failure if the patient's KOH test is positive or the patient's fungal culture is positive.
Measured: Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)
Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population)
Clinical Cure: To be considered a clinical cure the patient's total severity score must be ≤ 2 with no individual severity score > 1.
Clinical Failure: A patient will be considered a Clinical Failure if the patient's total severity score is > 2 or any individual score is > 1.
Local Signs and Symptoms The most severely affected area will be identified as the target lesion at the baseline visit and will be used for the assessments at Day 42 and Day 56 visits.
The Clinical Signs and Symptoms of tinea pedis will be rated by the Investigator as "none", "mild," "moderate" or "severe" using the following standardized rating scale.
0 = None (complete absence of any sign or symptom)
- = Mild (Slight)
- = Moderate (Definitely Present)
- = Severe (Marked, Intense)
The following signs and symptoms will be rated at each visit:
- Signs: Fissuring/cracking, erythema, maceration, and scaling
- Symptoms: Pruritus and burning/stinging
Measured: Two weeks after the end of treatment (Day 56 ± 4) (Superiority)
Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population)
Mycological Cure: To be considered a mycological cure the patient must have a negative Potassium hydroxide (KOH) test and a negative fungal culture.
Mycological Failure: A patient will be considered a Mycological Failure if the patient's KOH test is positive or the patient's fungal culture is positive.
Measured: Two weeks after the end of treatment (Day 56 ± 4) (Superiority)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start23 Aug 2018
- Primary completion24 Jan 2019
- Study completion24 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, three-arm, parallel group, multiple-site bioequivalence study with clinical endpoints.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 831 participants (actual)
Sponsor and investigators
- Lead sponsor
- Encube Ethicals Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services, ACM Global Laboratories
- Responsible party
- Sponsor
- Investigators
- Lalatendu Panigrahi, Study director, Encube Ethicals Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824912
- Sponsor's protocol ID
- 71875502
- Status last verified
- Jun 2019
- First submitted
- 29 Jan 2019
- Last updated
- 27 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd) to Ketoconazole Cream 2% (G&W Laboratories Inc.) in the Treatment of Tinea Pedis
- ClinicalTrials.gov ID
- NCT03824912
- Acronym / sponsor ID
- 71875502
- Conditions
- Tinea Pedis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 831 participants (actual)
- Lead sponsor
- Encube Ethicals Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services, ACM Global Laboratories
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 24 Jan 2019 (actual)
- Study completion
- 24 Jan 2019 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Posted 13 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis
Detailed description
A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd) to Ketoconazole Cream 2% (G\&W Laboratories Inc.) in the Treatment of Tinea Pedis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, double-blind, placebo-controlled, three-arm, parallel group, multiple-site bioequivalence study with clinical endpoints.
| Arm | Type | Receives |
|---|---|---|
| Test: Ketoconazole Cream 2% | Experimental | Drug: Ketoconazole Cream 2%Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd) |
| Reference: Ketoconazole Cream 2% | Active comparator | Drug: Ketoconazole Cream 2% (G&W Laboratories Inc.)Ketoconazole Cream 2% (G\&W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.) |
| Placebo: Cream (Test vehicle) | Placebo comparator | Drug: PlaceboPlacebo Cream (Test vehicle) (Encube Ethicals Pvt Ltd) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy male or non-pregnant, non-lactating female, ≥ 18 years of age.
- Signed informed consent form (ICF) that meets all criteria of current Food and Drug Administration regulations.
- Female patient of childbearing potential must not be pregnant or lactating at Visit 1 (as confirmed by a negative urine pregnancy test with a sensitivity of less than 50 milli-International unit (mIU/mL) or equivalent units of human chorionic gonadotropin).
- Female patient of childbearing potential must agree to the use of a reliable method of contraception throughout the study (e.g., total abstinence, intrauterine device, a double-barrier method, oral, transdermal, injected, or implanted non-hormonal or hormonal contraceptive) throughout the study. A sterile sexual partner is not considered an adequate form of birth control. If the female is using any estrogen or oral contraceptive therapy, the same product must have been taken for at least one month before Visit 1.
- Have clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin).
Key exclusion criteria (18 listed)
- Females who are pregnant, lactating or planning to become pregnant during the study period.
- History of or current psoriasis, Lichen planus or contact dermatitis involving the feet within the previous 12 months.
- History of dermatophyte infections with a lack of response to antifungal therapy (recurrent tinea pedis [i.e., more than 3 infections in the past 12 months] that were unresponsive to previous antifungal therapy).
- History of allergy, hypersensitivity, or intolerance to ketoconazole, other imidazoles, sulfites or any other component of the study product.
- Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
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 |
|---|---|---|
| Ketoconazole Cream 2%Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses. | Drug | Test: Ketoconazole Cream 2% |
| Ketoconazole Cream 2% (G&W Laboratories Inc.)Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses. | Drug | Reference: Ketoconazole Cream 2% |
| PlaceboPatients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses. | Drug | Placebo: Cream (Test vehicle) |
Primary outcome
Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Equivalence: Per-Protocol Population)
Time frame: Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)
Equivalence: Per-Protocol Population Therapeutic Cure: To be considered a Therapeutic Cure, the patient must have both Clinical and Mycological Cure of tinea pedis. Therapeutic Failure: A patient will be considered a Therapeutic Failure if: 1. the patient is a Clinical or Mycological Failure 2. the patient was considered to have an insufficient therapeutic response 3. the patient used topical drug therapy for irritation or pruritus on the feet after the treatment phase of the study
Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population)
Time frame: Two weeks after the end of treatment (Day 56 ± 4) (Superiority)
Superiority: modified Intent-to-Treat Population Therapeutic Cure: To be considered a Therapeutic Cure, the patient must have both Clinical and Mycological Cure of tinea pedis. Therapeutic Failure: A patient will be considered a Therapeutic Failure if: 1. the patient is a Clinical or Mycological Failure 2. the patient was considered to have an insufficient therapeutic response 3. the patient used topical drug therapy for irritation or pruritus on the feet after the treatment phase of the study
4 secondary outcomes
Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Equivalence: Per-Protocol Population)
Time frame: Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)
Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Equivalence: Per-Protocol Population)
Time frame: Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)
Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population)
Time frame: Two weeks after the end of treatment (Day 56 ± 4) (Superiority)
Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population)
Time frame: Two weeks after the end of treatment (Day 56 ± 4) (Superiority)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Lalatendu Panigrahi study director
Encube Ethicals Pvt. Ltd.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketoconazole Cream 2% and Ketoconazole Cream 2% (G&W Laboratories Inc.) in people with Tinea Pedis, run by Encube Ethicals Pvt. Ltd. at 9 sites in 3 countries.
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 9 inclusion and 18 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 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Belize, Saint Lucia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Equivalence: Per-Protocol Population) (time frame: Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)). 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 27 Jun 2019.