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.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Encube Ethicals Pvt Ltd
- Enrollment
- 224
- Locations
- 8
- Primary Endpoint
- Subjects with mycological cure at test of cure (TOC) visit and test of sustainable cure visit. Mycological cure is defined as a negative KOH test.
Study Overview
Brief Summary
This is a double-blind,multicentric, randomized, parallel group, comparative bioequivalence study withclinical end-point to evaluate the efficacy and safety of fixed dosecombination of clotrimazole 1% w/w + hydrocortisone 1 % w/w cream incomparision with the canesten HC cream for the treatment of fungal skininfection with co-existing symptoms of inflammation. A total of 224 male andfemale subjects with who pass inclusion and exclusion criteria will be enrolledin the study. Primary objective is to evaluate the efficacy andsecondary objective is to evaluate the safety of fixed dose combination. Visit1 will be screening visit at day -5 to 0, visit 2 will be randomization visitat day 1, visit 3 will be evaluation .end of therapy visit at day 7±1, visit 3will be end of therapy visit/test of cure visit at day 14±1, visit 5 will betest of cure visit/test of sustainable cure visit at day 21 ±1, visit 6 will betest of sustainable cure visit at 28 ±1 day. Primary end point will be measuredby subjects with mycological cure at test of cure visit (negative KOH test) andtest of sustainable cure visit. Secondary visit will be subjective assessment,objective assessment and physician’s global assessment. Safety assessment willbe done by measuring incidence and nature of adverse events, incidence of drugrelated adverse events, changes in vital signs from baseline to end of study,changes in haematology and biochemistry.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
- •11.Presence of any other infection of the skin or other disease process that might confound the treatment evaluation.
- •12.History of dermatophyte infections unresponsive to systemic or topical antifungal drugs.
- •13.Subjects with history of diabetes mellitus and systemic illness.
- •14.Participate in any other clinical study during last 30 days.
- •15.Subject is a female who is pregnant or willing to get pregnant, and not ready to use contraceptive measures during the trial period or breast feeding.
- •16.Any other clinically significant abnormal medical condition that in the Investigators judgment would put the subject at increased risk of illness or injury, would interfere with the study participation or would interfere with the evaluation or quality of the data.
Outcomes
Primary Outcomes
Subjects with mycological cure at test of cure (TOC) visit and test of sustainable cure visit. Mycological cure is defined as a negative KOH test.
Time Frame: Day -5 to 0, day 14, 21, 28 plus or minus 1
Secondary Outcomes
- 1)Reduction or absence of pruritus, erythema and scaling of infected area.(2)Total severity score no more than 2 with no individual severity score greater than 1)