Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis
Study Details
Study Description
Brief Summary
Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Test: Ketoconazole Cream 2% Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd) |
Drug: 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.
|
| Active Comparator: Reference: Ketoconazole Cream 2% Ketoconazole Cream 2% (G&W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.) |
Drug: 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.
|
| Placebo Comparator: Placebo: Cream (Test vehicle) 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.
|
Outcome Measures
Primary Outcome Measures
- Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Equivalence: Per-Protocol Population) [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: 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
- Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population) [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: 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
Secondary Outcome Measures
- Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Equivalence: Per-Protocol Population) [Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)]
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
- Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Equivalence: Per-Protocol Population) [Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)]
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.
- Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population) [Two weeks after the end of treatment (Day 56 ± 4) (Superiority)]
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
- Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population) [Two weeks after the end of treatment (Day 56 ± 4) (Superiority)]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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).
-
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.
Exclusion Criteria:
-
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.
-
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
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Long Beach Clinical Trial Services, Inc. | Long Beach | California | United States | 90806 |
| 2 | San Marcus Research Clinic, Inc. | Miami Lakes | Florida | United States | 33014 |
| 3 | International Dermatology Research, Inc. | Miami | Florida | United States | 33144 |
| 4 | FXM Research Corp. | Miami | Florida | United States | 33175 |
| 5 | FXM Research Miramar | Miramar | Florida | United States | 33027 |
| 6 | MOORE Clinical Research, Inc. | Tampa | Florida | United States | 33609 |
| 7 | PEAK Research, LLC | Upper Saint Clair | Pennsylvania | United States | 15241 |
| 8 | FXM Research International | Belize City | Belize | ||
| 9 | FXM Research International | Castries | Saint Lucia |
Sponsors and Collaborators
- Encube Ethicals Pvt. Ltd.
- Novum Pharmaceutical Research Services
- ACM Global Laboratories
Investigators
- Study Director: Lalatendu Panigrahi, Encube Ethicals Pvt. Ltd.
Study Documents (Full-Text)
More Information
Publications
None provided.- 71875502
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Test: Ketoconazole Cream 2% | Reference: Ketoconazole Cream 2% | Placebo: Cream (Test Vehicle) |
|---|---|---|---|
| Arm/Group Description | Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd) 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. | Ketoconazole Cream 2% (G&W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.) 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. | Placebo Cream (Test vehicle) (Encube Ethicals Pvt Ltd) 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. |
| Period Title: Overall Study | |||
| STARTED | 332 | 335 | 164 |
| COMPLETED | 192 | 201 | 96 |
| NOT COMPLETED | 140 | 134 | 68 |
Baseline Characteristics
| Arm/Group Title | Test: Ketoconazole Cream 2% | Reference: Ketoconazole Cream 2% | Placebo: Cream (Test Vehicle) | Total |
|---|---|---|---|---|
| Arm/Group Description | Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd) 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. | Ketoconazole Cream 2% (G&W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.) 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. | Placebo Cream (Test vehicle) (Encube Ethicals Pvt Ltd) 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. | Total of all reporting groups |
| Overall Participants | 314 | 319 | 156 | 789 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
45.6
(13.6)
|
46.7
(13.9)
|
44.8
(14.4)
|
45.9
(13.9)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
131
41.7%
|
114
35.7%
|
64
41%
|
309
39.2%
|
| Male |
183
58.3%
|
205
64.3%
|
92
59%
|
480
60.8%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
154
49%
|
153
48%
|
75
48.1%
|
382
48.4%
|
| Not Hispanic or Latino |
160
51%
|
166
52%
|
81
51.9%
|
407
51.6%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
1
0.6%
|
1
0.1%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
147
46.8%
|
153
48%
|
74
47.4%
|
374
47.4%
|
| White |
166
52.9%
|
163
51.1%
|
80
51.3%
|
409
51.8%
|
| More than one race |
1
0.3%
|
3
0.9%
|
1
0.6%
|
5
0.6%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Equivalence: Per-Protocol Population) |
|---|---|
| Description | 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 |
| Time Frame | Two weeks after the end of treatment (Day 56 ± 4) (Equivalence) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Per-Protocol population was used for this analysis to determine equivalence between the Test and Reference groups only. To determine equivalence, only the test and reference treatment arms are analyzed. |
| Arm/Group Title | Test: Ketoconazole Cream 2% | Reference: Ketoconazole Cream 2% |
|---|---|---|
| Arm/Group Description | Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd) 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. | Ketoconazole Cream 2% (G&W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.) 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. |
| Measure Participants | 184 | 191 |
| Count of Participants [Participants] |
89
28.3%
|
90
28.2%
|
| Title | Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population) |
|---|---|
| Description | 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 |
| Time Frame | Two weeks after the end of treatment (Day 56 ± 4) (Superiority) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The MITT Population was used for analysis. |
| Arm/Group Title | Test: Ketoconazole Cream 2% | Reference: Ketoconazole Cream 2% | Placebo: Cream (Test Vehicle) |
|---|---|---|---|
| Arm/Group Description | Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd) 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. | Ketoconazole Cream 2% (G&W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.) 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. | Placebo Cream (Test vehicle) (Encube Ethicals Pvt Ltd) 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. |
| Measure Participants | 195 | 199 | 97 |
| Count of Participants [Participants] |
92
29.3%
|
94
29.5%
|
26
16.7%
|
| Title | Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Equivalence: Per-Protocol Population) |
|---|---|
| Description | 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 |
| Time Frame | Two weeks after the end of treatment (Day 56 ± 4) (Equivalence) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Per-Protocol population was used for this analysis to determine equivalence between the Test and Reference groups only. To determine equivalence, only the test and reference treatment arms are analyzed. |
| Arm/Group Title | Test: Ketoconazole Cream 2% | Reference: Ketoconazole Cream 2% |
|---|---|---|
| Arm/Group Description | Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd) 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. | Ketoconazole Cream 2% (G&W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.) 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. |
| Measure Participants | 184 | 191 |
| Count of Participants [Participants] |
97
30.9%
|
110
34.5%
|
| Title | Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Equivalence: Per-Protocol Population) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PP population was used for this analysis to determine equivalence between the Test and Reference groups only. One patient had an inconclusive result for the fungal culture at Visit 3 and was excluded from the analysis of the secondary endpoint for the mycological cure. Patient was a clinical failure and was included in the primary analysis. |
| Arm/Group Title | Test: Ketoconazole Cream 2% | Reference: Ketoconazole Cream 2% |
|---|---|---|
| Arm/Group Description | Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd) 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. | Ketoconazole Cream 2% (G&W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.) 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. |
| Measure Participants | 184 | 190 |
| Count of Participants [Participants] |
127
40.4%
|
118
37%
|
| Title | Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population) |
|---|---|
| Description | 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 |
| Time Frame | Two weeks after the end of treatment (Day 56 ± 4) (Superiority) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The MITT population was used for analysis. |
| Arm/Group Title | Test: Ketoconazole Cream 2% | Reference: Ketoconazole Cream 2% | Placebo: Cream (Test Vehicle) |
|---|---|---|---|
| Arm/Group Description | Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd) 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. | Ketoconazole Cream 2% (G&W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.) 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. | Placebo Cream (Test vehicle) (Encube Ethicals Pvt Ltd) 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. |
| Measure Participants | 195 | 199 | 97 |
| Count of Participants [Participants] |
100
31.8%
|
116
36.4%
|
35
22.4%
|
| Title | Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The MITT population was used for the analysis. One patient had an inconclusive result for the fungal culture at Visit 3 and was excluded from the analysis of the secondary endpoint for the mycological cure. Patient was a clinical failure and was included in the primary analysis. |
| Arm/Group Title | Test: Ketoconazole Cream 2% | Reference: Ketoconazole Cream 2% | Placebo: Cream (Test Vehicle) |
|---|---|---|---|
| Arm/Group Description | Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd) 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. | Ketoconazole Cream 2% (G&W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.) 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. | Placebo Cream (Test vehicle) (Encube Ethicals Pvt Ltd) 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. |
| Measure Participants | 195 | 198 | 97 |
| Count of Participants [Participants] |
132
42%
|
122
38.2%
|
39
25%
|
Adverse Events
| Time Frame | 5 months | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The "Total Number of Participants at Risk" is not consistent with the numbers provided in any of the rows in the Participant Flow module, since the Overall Summary of Adverse Events is based on the Safety Population. The Safety population will include all randomized patients who use at least one dose of product. | |||||
| Arm/Group Title | Test: Ketoconazole Cream 2% | Reference: Ketoconazole Cream 2% | Placebo: Cream (Test Vehicle) | |||
| Arm/Group Description | Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd) 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. | Ketoconazole Cream 2% (G&W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.) 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. | Placebo Cream (Test vehicle) (Encube Ethicals Pvt Ltd) 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. | |||
All Cause Mortality |
||||||
| Test: Ketoconazole Cream 2% | Reference: Ketoconazole Cream 2% | Placebo: Cream (Test Vehicle) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/314 (0%) | 0/319 (0%) | 0/156 (0%) | |||
Serious Adverse Events |
||||||
| Test: Ketoconazole Cream 2% | Reference: Ketoconazole Cream 2% | Placebo: Cream (Test Vehicle) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/314 (0%) | 0/319 (0%) | 0/156 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Test: Ketoconazole Cream 2% | Reference: Ketoconazole Cream 2% | Placebo: Cream (Test Vehicle) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/314 (3.8%) | 15/319 (4.7%) | 6/156 (3.8%) | |||
| Gastrointestinal disorders | ||||||
| Diarrhoea | 1/314 (0.3%) | 1 | 1/319 (0.3%) | 1 | 0/156 (0%) | 0 |
| Dyspepsia | 0/314 (0%) | 0 | 1/319 (0.3%) | 1 | 0/156 (0%) | 0 |
| Gastritis | 0/314 (0%) | 0 | 0/319 (0%) | 0 | 1/156 (0.6%) | 1 |
| Toothache | 0/314 (0%) | 0 | 0/319 (0%) | 0 | 1/156 (0.6%) | 1 |
| Infections and infestations | ||||||
| Nasopharyngitis | 4/314 (1.3%) | 4 | 4/319 (1.3%) | 4 | 1/156 (0.6%) | 1 |
| Upper respiratory tract infection | 1/314 (0.3%) | 1 | 0/319 (0%) | 0 | 0/156 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| Arthropod bite | 0/314 (0%) | 0 | 1/319 (0.3%) | 1 | 0/156 (0%) | 0 |
| Contusion | 0/314 (0%) | 0 | 1/319 (0.3%) | 1 | 0/156 (0%) | 0 |
| Investigations | ||||||
| Blood pressure increased | 1/314 (0.3%) | 1 | 0/319 (0%) | 0 | 1/156 (0.6%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 0/314 (0%) | 0 | 0/319 (0%) | 0 | 1/156 (0.6%) | 1 |
| Back pain | 1/314 (0.3%) | 1 | 2/319 (0.6%) | 2 | 0/156 (0%) | 0 |
| Joint swelling | 0/314 (0%) | 0 | 0/319 (0%) | 0 | 1/156 (0.6%) | 1 |
| Muscle spasms | 0/314 (0%) | 0 | 2/319 (0.6%) | 2 | 0/156 (0%) | 0 |
| Pain in extremity | 0/314 (0%) | 0 | 2/319 (0.6%) | 2 | 0/156 (0%) | 0 |
| Nervous system disorders | ||||||
| Headache | 3/314 (1%) | 3 | 5/319 (1.6%) | 6 | 0/156 (0%) | 0 |
| Reproductive system and breast disorders | ||||||
| Adnexa uteri pain | 0/314 (0%) | 0 | 0/319 (0%) | 0 | 1/156 (0.6%) | 1 |
| Dysmenorrhoea | 1/314 (0.3%) | 1 | 0/319 (0%) | 0 | 0/156 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| Blister | 1/314 (0.3%) | 1 | 0/319 (0%) | 0 | 0/156 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
In the Clinical Trials Agreements between the sites and the Contract Research Organization, sites are instructed that the Investigator shall not publish, or seek to publish, either in whole or in part any results of the Study without the written consent.
Results Point of Contact
| Name/Title | Dr. Lalatendu Panigrahi, Chief Scientific Officer |
|---|---|
| Organization | Encube Ethicals Pvt Ltd |
| Phone | +91-22-6264-7002 |
| lalatendu.p@encubeethicals.com |
- 71875502