To check effectiveness of Clotrimazole plus Hydrocortisone cream for fungal skin infectio
- Conditions
- Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue
- Registration Number
- CTRI/2017/12/010798
- Lead Sponsor
- Encube Ethicals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 209
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.Timepoint: Day -5 to 0, day 14, 21, 28 plus or minus 1
- Secondary Outcome Measures
Name Time Method 1)Reduction or absence of pruritus, erythema and scaling of infected area. <br/ ><br>2)Total severity score no more than 2 with no individual severity score greater than 1 <br/ ><br>(3)Percentage reduction in the pruritus (itching) by VAS score. <br/ ><br>(4)The investigatorâ??s assessment on efficacy of the treatment based on four point Physicianâ??s Global Assessment (PGA) will be done as follows: Poor, satisfactory, good and excellent. <br/ ><br>Timepoint: Day -5 to 0, day 7, 14, 21, 28 plus or minus 1