A clinical trial intended to Evaluate the Efficacy and Safety of Ketoconazole 2% Cream of Cadila Healthcare Limited with Ketoconazole 2% Cream of Teva Pharmaceuticals USA in Subjects with Tinea Pedis.
- Conditions
- Health Condition 1: B353- Tinea pedis
- Registration Number
- CTRI/2021/10/037081
- Lead Sponsor
- Cadila Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 794
Subjects will be eligible for inclusion in this study only if all of the following criteria apply:
1.Male or non-lactating & non-pregnant female aged 18 years and older.
2.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 will be not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin), and 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).
3.The sum of the clinical signs and symptoms scores of the target lesion should be at least 4, including a minimum score of at least 2 for erythema AND a minimum score of 2 for either scaling or pruritus (on a scale of 0 to 3, where 2 indicates moderate severity).
4.Subject should agree to maintain personal foot hygiene throughout the study.
5.Female of childbearing potential must have a negative urine pregnancy test and willing to use an acceptable form of birth control during the study.
6.Subject must have the study fully explained to them and signed and dated an approved informed consent document prior to initiating any study related procedure.
Subjects will not be eligible for inclusion in this study if any of the following criteria apply:
1.Female who is pregnant, breast feeding or who wish to become pregnant during the study period.
2.Use of antipruritics, including antihistamines, within 72 hours prior to Visit 1.
3.Use of topical corticosteroid, antibiotics or antifungal therapy within 2 weeks prior to Visit 1.
4.Use of systemic (e.g., oral or injectable) corticosteroid, antibiotics or antifungal therapy within 1 month prior to Visit 1.
5.Use of oral terbinafine or itraconazole within 2 months prior to Visit 1.
6.Subject having signs/symptoms suggestive of COVID-19.
7.Subject with history of HIV or any subject who is on immunosuppressive medication or radiation therapy within 3 months prior to Visit 1.
8.Subject with confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
9.Presence of any other infection of the foot or other disease process that might confound the treatment evaluation.
10.History of dermatophyte infections unresponsive to systemic or topical antifungal drugs.
11.Subject with history of diabetes mellitus not controlled by diet as per investigatorâ??s discretion.
12.Any known hypersensitivity to ketoconazole, other imidazoles or to any component of the formulation, particularly sulfites.
13.Subject who has taken part in a clinical trial within 30 days prior to randomization.
14.Institutionalized subject.
15.Subject who lives in the same household as currently enrolled subject.
16.Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into the trial.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method . To evaluate the bioequivalence (with clinical end point) of Ketoconazole 2% Cream of Cadila Healthcare Limited with Ketoconazole Cream 2% of Teva Pharmaceuticals USA in subjects with tinea pedis. <br/ ><br>2. To evaluate the superiority of Ketoconazole 2% Cream of Cadila Healthcare Limited and Ketoconazole 2% Cream of Teva Pharmaceuticals USA over placebo in subjects with tinea pedis. <br/ ><br>Timepoint: 4 weeks
- Secondary Outcome Measures
Name Time Method To assess safety and tolerability of study treatments. <br/ ><br> <br/ ><br>Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). <br/ ><br>Timepoint: Safty will be assessed for total study duration of 09 weeks.