Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03824912
Recruitment Status : Completed
First Posted : January 31, 2019
Results First Posted : June 13, 2019
Last Update Posted : June 27, 2019
Sponsor:
Collaborators:
Novum Pharmaceutical Research Services
ACM Global Laboratories
Information provided by (Responsible Party):
Encube Ethicals Pvt. Ltd.

Tracking Information
First Submitted Date  ICMJE January 29, 2019
First Posted Date  ICMJE January 31, 2019
Results First Submitted Date  ICMJE April 11, 2019
Results First Posted Date  ICMJE June 13, 2019
Last Update Posted Date June 27, 2019
Actual Study Start Date  ICMJE August 23, 2018
Actual Primary Completion Date January 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
Primary Efficacy Endpoint: The proportion of patients in each treatment group with a Therapeutic Cure of tinea pedis [ Time Frame: Two weeks after the end of treatment (Day 56 ± 4) ]
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
Change History Complete list of historical versions of study NCT03824912 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • 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) ]
    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
  • 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) ]
    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) [ Time Frame: 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)
    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
  • 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) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • Secondary Efficacy Endpoint: The proportion of patients in each treatment group with a Clinical Cure of tinea pedis [ Time Frame: Two weeks after the end of treatment (Day 56 ± 4) ]
    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.
  • Secondary Efficacy Endpoint:The proportion of patients in each treatment group with a Mycological Cure of tinea pedis [ Time Frame: Two weeks after the end of treatment (Day 56 ± 4) ]
    Mycological Cure: To be considered a mycological cure the patient must have a negative 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis
Official Title  ICMJE 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
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, double-blind, placebo-controlled, three-arm, parallel group, multiple-site bioequivalence study with clinical endpoints.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
All study products are blinded and provided to the patients in the same packaging.
Primary Purpose: Treatment
Condition  ICMJE Tinea Pedis
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Test: Ketoconazole Cream 2%
    Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd)
    Intervention: Drug: Ketoconazole Cream 2%
  • Active Comparator: Reference: Ketoconazole Cream 2%
    Ketoconazole Cream 2% (G&W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.)
    Intervention: Drug: Ketoconazole Cream 2% (G&W Laboratories Inc.)
  • Placebo Comparator: Placebo: Cream (Test vehicle)
    Placebo Cream (Test vehicle) (Encube Ethicals Pvt Ltd)
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2019)
831
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 24, 2019
Actual Primary Completion Date January 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy male or non-pregnant, non-lactating female, ≥ 18 years of age.
  2. Signed informed consent form (ICF) that meets all criteria of current Food and Drug Administration regulations.
  3. 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).
  4. 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.
  5. 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).
  6. 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).
  7. The sum of clinical signs and symptoms scores of the target lesion ≥ 4. See Appendix A for scoring scale:

    1. Signs: Fissuring/cracking, erythema, maceration and scaling
    2. 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:

  1. Females who are pregnant, lactating or planning to become pregnant during the study period.
  2. History of or current psoriasis, Lichen planus or contact dermatitis involving the feet within the previous 12 months.
  3. 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).
  4. History of allergy, hypersensitivity, or intolerance to ketoconazole, other imidazoles, sulfites or any other component of the study product.
  5. Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
  6. Current uncontrolled diabetes.
  7. 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.
  8. 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.
  9. 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.
  10. Use of antipruritics, including antihistamines, within 72 hours before Visit 1.
  11. Use of topical corticosteroids, topical antibiotics or topical antifungal therapy (e.g., clotrimazole, econazole, fluconazole) within 2 weeks before Visit 1.
  12. 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.
  13. Use of oral terbinafine or itraconazole within 2 months before Visit 1.
  14. Use of immunosuppressive medication or radiation therapy within 3 months before Visit 1.
  15. Receipt of any drug as part of a research study within 30 days before Visit 1.
  16. Previous participation in this study.
  17. Employee of the Investigator or research center or their immediate family members.
  18. Inability to understand the requirements of the study and the relative information or are unable or unwilling to comply with the study protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belize,   Saint Lucia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03824912
Other Study ID Numbers  ICMJE 71875502
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Encube Ethicals Pvt. Ltd.
Study Sponsor  ICMJE Encube Ethicals Pvt. Ltd.
Collaborators  ICMJE
  • Novum Pharmaceutical Research Services
  • ACM Global Laboratories
Investigators  ICMJE
Study Director: Lalatendu Panigrahi Encube Ethicals Pvt. Ltd.
PRS Account Encube Ethicals Pvt. Ltd.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP