| CTRI Number |
CTRI/2020/05/025300 [Registered on: 22/05/2020] Trial Registered Prospectively |
| Last Modified On: |
18/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Study to evaluate the Efficacy & Safety of KETOKONE cream in the treatment of skin infections |
|
Scientific Title of Study
|
A Prospective, Interventional Randomized Parallel Double blind active-controlled Clinical Study to evaluate the Efficacy and Safety of KETOKONE cream (Ketoconazole Cream BP 2 % w/w) in the treatment of skin infections. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/CR/APL/1121/104 version no:01 date 21 Nov 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayanta Kumar |
| Designation |
Dermatologist |
| Affiliation |
Calcutta School of Tropical Medicine |
| Address |
# 108 Government of West Bengal
Chittranjan Avenue Calcutta-
Kolkata
WEST BENGAL
700073
India |
| Phone |
9433245994 |
| Fax |
|
| Email |
jkumarbr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish S |
| Designation |
Director operations |
| Affiliation |
ICBio Clinical Research Pvt Ltd |
| Address |
#16 and 18 ICBio Tower
Yelahanka Main Road
Chikkabettahalli Vidyaranyapura
Bangalore
KARNATAKA
560 097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish S |
| Designation |
Director operations |
| Affiliation |
ICBio Clinical Research Pvt Ltd |
| Address |
#16 and 18 ICBio Tower
Yelahanka Main Road
Chikkabettahalli Vidyaranyapura
Bangalore
KARNATAKA
560 097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Agio Pharmaceuticals Ltd |
| Address |
A 38 Nandjyot Industrial Estate Kurla Andheri Road Mumbai 400072 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jayanta Kumar |
Calcutta School of Tropical Medicine |
# 108, Government of West Bengal
Chittranjan Avenue Calcutta
Kolkata
WEST BENGAL |
9433245994
jkumarbr@gmail.com |
| Dr Savitha |
Rajlakshmi hospital |
Lakshmipura main road
Vidyananapura
Bangalore
KARNATAKA |
9738877298
drsavithasomaiah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajalakshmi hospital institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KETOKONE cream |
A thin film of Ketoconazole Cream BP 2 % w/w should be applied to the affected areas of skin once or twice daily for 28 days |
| Comparator Agent |
Nizoral cream |
A thin film of Ketoconazole Cream BP 2 % w/w should be applied to the affected areas of skin once or twice daily for 28 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Reduction of Clinical Signs and Symptoms of skin infection assessed by clinical examination from baseline to EOT
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 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Self-Assessment of General Health from baseline to EOT
2.IP Tolerance
3.Assessment of safety of the Investigational products by monitoring the adverse event |
Visit 1, Visit 2, Visit 3 and visit 4 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/05/2020 |
| Date of Study Completion (India) |
20/10/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="5" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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
|