A Double-blind, Multicentric, Randomized, Parallel Group, Comparative Bioequivalence study with Clinical end-point to evaluate the Efficacy and Safety of Fixed Dose Combination of Clotrimazole 1% w/w plus Hydrocortisone 1% w/w Cream (Test) of Encube Ethicals Pvt. Ltd., India compared with the Canesten HC Cream (Reference) of Bayer PLC, UK for the treatment of fungal skin infection with co-existing symptoms of inflammation. - .

Encube Ethicals Pvt Ltd0 sites209 target enrollmentTBD

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue
Sponsor: Encube Ethicals Pvt Ltd
Enrollment: 209
Status: Completed
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

TBD

End Date

December 19, 2018

Last Updated

4 years ago

Study Type

Interventional

Sponsor

•1\.Subjects or their legally acceptable representative who are able to provide written, signed, dated and ethics committee approved informed consent form before performing any screening procedures.
•2\.Male and/or female of 18\-65 years (both inclusive)
•3\.Subjects with clinical manifestations of localized epidermal dermatophytosis and candidiasis provisionally confirmed at baseline by a microscopic examination of 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).
•4\.The sum of the clinical signs and symptoms scores of the target lesion is 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\-3, where 2 indicates moderate severity).
•5\.Willingness to comply with the study schedule and procedures.

•1\.Known hypersensitivity to clotrimazole or hydrocortisone or any of the excipients in this product.
•2\.Untreated bacterial skin infection such as syphilis or tuberculosis.
•3\.Viral skin diseases (e.g. herpes simplex, chicken pox, etc.)
•4\.Use of oral steroids or immunosuppressive agents within past 30 days.
•5\.Use of antipruritics, including antihistamines, within 772 hours prior to entry into the study.
•6\.Use of topical corticosteroid, antibiotic or antifungal therapy within 2 weeks prior to entry into the study.
•7\.Use of systemic (e.g., oral or injectable) corticosteroid, antibiotic or antifungal therapy within 1 month prior to entry into the study.
•8\.Use of oral terbinafine or itraconazole within 2 months prior to entry into the study.
•9\.Use of immunosuppressive medication or radiation therapy within 3 months prior to entry into the study.
•10\.Confluent, diffuse type fungal skin infection of the entire body surface.