Clinical Study to evaluate the Efficacy & Safety of KETOKONE cream in the treatment of skin infections

Phase 3

Completed

• Conditions: Other specified local infections of the skin and subcutaneous tissue,

• Registration Number: CTRI/2020/05/025300
• Lead Sponsor: Agio Pharmaceuticals Ltd

Brief Summary

A Prospective, Interventional, Randomized, Parallel, Double blind, active-controlled, Clinical Study to evaluate the Efficacy & Safety of KETOKONE cream (Ketoconazole Cream BP 2 % w/w) in the treatment of skin infections.

Total of  60 subjects will be enrolled in the study.

Test: 30 subjects KETOKONE cream (Ketoconazole Cream BP 2 % w/w)

Reference product : 30 Nizoral cream (Ketoconazole Cream BP 2 % w/w )

Total study duration of the study is approximately  35  Days  (28 days treatment plus follow up  on 35 days

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-28
• Study Completion: 2020-10-20
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1.Healthy male and female subjects 2.Age 18-65 or older, with good mental health 3.Subjects having any one skin infection mentioned below caused by Trichophytonrubrum, Trichophytonmentagrophytes, Microsporumcanis and Epidermophytonfloccosum: Tinea corporis Tinea cruris Tinea manus Tinea pedis infections, Cutaneous candidosis Seborrhoeic dermatitis infection 5.For scoring scale: a.Signs: Fissuring/cracking, erythema, maceration and scaling b.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.
• 6.Subject who, in the opinion of the investigator, are free of any medical condition(s) that may interfere with study participation or affect study measures 7.Not pregnant, no systemic disease.
• 8.Willing to provide written informed consent for participation in the study and adhere to the protocol requirements.
• 9.Patients who agreed to return for follow-up visits.

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 imidazole’s, 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 oral terbinafine or Iitraconazole within 2 months before Visit 1.
• 13.Use of immunosuppressive medication or radiation therapy within 3 months before Visit 1.
• 14 Receipt of any drug as part of a research study within 30 days before.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2.Proportion of patients in each treatment group with a Therapeutic Cure in skin infection from baseline to EOT	Visit 1, Visit 2, Visit 3 and visit 4
1.Reduction of Clinical Signs and Symptoms of skin infection assessed by clinical examination from baseline to EOT	Visit 1, Visit 2, Visit 3 and visit 4

Secondary Outcome Measures

Name	Time	Method
1.Self-Assessment of General Health from baseline to EOT	2.IP Tolerance

Trial Locations

Locations (2)

Calcutta School of Tropical Medicine; 🇮🇳 Kolkata, WEST BENGAL, India

Rajlakshmi hospital; 🇮🇳 Bangalore, KARNATAKA, India

Calcutta School of Tropical Medicine

🇮🇳Kolkata, WEST BENGAL, India

Dr Jayanta Kumar

Principal investigator

9433245994

jkumarbr@gmail.com