A Phase 3 interventional study of Ketoconazole Cream 2% and Ketoconazole Cream 2% (G&W Laboratories Inc.) in Tinea Pedis, sponsored by Encube Ethicals Pvt. Ltd.. Completed at 9 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-27.
Sponsored by Encube Ethicals Pvt. Ltd. · Phase 3, Interventional, and Treatment
Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis
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
73 studies on the registry are indexed under Tinea Pedis; 8 are open to participants now.
This study's enrollment of 831 is above the median of 128 across 66 interventional studies indexed under Tinea Pedis.
Browse Tinea Pedis studies →Encube Ethicals Pvt. Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
The sum of clinical signs and symptoms scores of the target lesion ≥ 4. See Appendix A for scoring scale:
Exclusion Criteria:
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.
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.
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.
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.
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.
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.
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd)
Drug: Ketoconazole Cream 2%
Ketoconazole Cream 2% (G\&W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.)
Drug: Ketoconazole Cream 2% (G&W Laboratories Inc.)
Placebo Cream (Test vehicle) (Encube Ethicals Pvt Ltd)
Drug: Placebo
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.
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.
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.
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: 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
Time frame: 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: 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
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 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) 1. = Mild (Slight) 2. = Moderate (Definitely Present) 3. = 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
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)
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.
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)
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) 1. = Mild (Slight) 2. = Moderate (Definitely Present) 3. = 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
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)
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.
Time frame: Two weeks after the end of treatment (Day 56 ± 4) (Superiority)
| Milestone | Test: Ketoconazole Cream 2% | Reference: Ketoconazole Cream 2% | Placebo: Cream (Test Vehicle) |
|---|---|---|---|
| Started | 332 | 335 | 164 |
| Completed | 192 | 201 | 96 |
| Not completed | 140 | 134 | 68 |
| Withdrew: Lost to follow-up | 18 | 15 | 8 |
| Withdrew: Negative baseline culture result | 118 | 112 | 57 |
| Withdrew: Non-compliance with study drug | 0 | 0 | 1 |
| Withdrew: Protocol violation | 1 | 4 | 1 |
| Withdrew: Withdrawal by subject | 3 | 2 | 1 |
| Withdrew: Participation in another study | 0 | 1 | 0 |
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
| Participants | Test: Ketoconazole Cream 2% | Reference: Ketoconazole Cream 2% |
|---|---|---|
| Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Equivalence: Per-Protocol Population) | 89 | 90 |
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
| Participants | Test: Ketoconazole Cream 2% | Reference: Ketoconazole Cream 2% | Placebo: Cream (Test Vehicle) |
|---|---|---|---|
| Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population) | 92 | 94 | 26 |
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) 1. = Mild (Slight) 2. = Moderate (Definitely Present) 3. = 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
| Participants | Test: Ketoconazole Cream 2% | Reference: Ketoconazole Cream 2% |
|---|---|---|
| Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Equivalence: Per-Protocol Population) | 97 | 110 |
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.
| Participants | Test: Ketoconazole Cream 2% | Reference: Ketoconazole Cream 2% |
|---|---|---|
| Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Equivalence: Per-Protocol Population) | 127 | 118 |
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) 1. = Mild (Slight) 2. = Moderate (Definitely Present) 3. = 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
| Participants | Test: Ketoconazole Cream 2% | Reference: Ketoconazole Cream 2% | Placebo: Cream (Test Vehicle) |
|---|---|---|---|
| Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population) | 100 | 116 | 35 |
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.
| Participants | Test: Ketoconazole Cream 2% | Reference: Ketoconazole Cream 2% | Placebo: Cream (Test Vehicle) |
|---|---|---|---|
| Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population) | 132 | 122 | 39 |
Collected over 5 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test: Ketoconazole Cream 2% | 0/314 (0%) | 0/314 (0%) | 12/314 (3.8%) |
| Reference: Ketoconazole Cream 2% | 0/319 (0%) | 0/319 (0%) | 15/319 (4.7%) |
| Placebo: Cream (Test Vehicle) | 0/156 (0%) | 0/156 (0%) | 6/156 (3.8%) |
| Event | Test: Ketoconazole Cream 2% | Reference: Ketoconazole Cream 2% | Placebo: Cream (Test Vehicle) |
|---|---|---|---|
| HeadacheNervous system disorders | 3/314 | 5/319 | 0/156 |
| NasopharyngitisInfections and infestations | 4/314 | 4/319 | 1/156 |
| GastritisGastrointestinal disorders | 0/314 | 0/319 | 1/156 |
| ToothacheGastrointestinal disorders | 0/314 | 0/319 | 1/156 |
| Blood pressure increasedInvestigations | 1/314 | 0/319 | 1/156 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/314 | 0/319 | 1/156 |
| Joint swellingMusculoskeletal and connective tissue disorders | 0/314 | 0/319 | 1/156 |
| Adnexa uteri painReproductive system and breast disorders | 0/314 | 0/319 | 1/156 |
| Back painMusculoskeletal and connective tissue disorders | 1/314 | 2/319 | 0/156 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 0/314 | 2/319 | 0/156 |
The Safety population was used for the baseline analysis population. The Safety population included all randomized patients who used at least one dose of product.
| Age, Continuous(years) | Test: Ketoconazole Cream 2% | Reference: Ketoconazole Cream 2% | Placebo: Cream (Test Vehicle) | Total |
|---|---|---|---|---|
| Mean | 45.6 ± 13.6 | 46.7 ± 13.9 | 44.8 ± 14.4 | 45.9 ± 13.9 |
| Sex: Female, Male(Participants) | Test: Ketoconazole Cream 2% | Reference: Ketoconazole Cream 2% | Placebo: Cream (Test Vehicle) | Total |
|---|---|---|---|---|
| Female | 131 | 114 | 64 | 309 |
| Male | 183 | 205 | 92 | 480 |
| Ethnicity (NIH/OMB)(Participants) | Test: Ketoconazole Cream 2% | Reference: Ketoconazole Cream 2% | Placebo: Cream (Test Vehicle) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 154 | 153 | 75 | 382 |
| Not Hispanic or Latino | 160 | 166 | 81 | 407 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Test: Ketoconazole Cream 2% | Reference: Ketoconazole Cream 2% | Placebo: Cream (Test Vehicle) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 147 | 153 | 74 | 374 |
| White | 166 | 163 | 80 | 409 |
| More than one race | 1 | 3 | 1 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Ketoconazole
Encube Ethicals Pvt. Ltd.