| CTRI Number |
CTRI/2022/07/043911 [Registered on: 11/07/2022] Trial Registered Prospectively |
| Last Modified On: |
31/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Other |
|
Public Title of Study
|
To evaluate the Safety and Efficacy of Ketoconazole Shampoo 2% For Topical Application of Novitium Pharma (a subsidiary of ANI Pharmaceuticals INC.) with Ketoconazole Shampoo 2% For Topical Application of Perrigo in subjects with Tinea Versicolor. |
|
Scientific Title of Study
|
A Randomized, Double Blind, Three- arm, Placebo Controlled, Parallel Design, Multi-Center, Clinical Endpoint Bioequivalence Study of Ketoconazole Shampoo 2% (Test Product) Compared with Ketoconazole Shampoo 2% (Reference Product) In Adult Subjects with Tinea Versicolor. |
| Trial Acronym |
N/A |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KETO-22-002 Ver 2.0 Dated 19 Apr 2022 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SD Rajendran |
| Designation |
Director and Head Operations |
| Affiliation |
Scitus Pharma Services Private Limited |
| Address |
Scitus Pharma Services Private Limited 2 294 DRR Avenue AUDCO Nagar 2nd street Kattupakkam Poonamallee
Thiruvallur
TAMIL NADU
600056
India |
| Phone |
9940306042 |
| Fax |
|
| Email |
sd.rajendran@scitusbiolab.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Senthilkumar |
| Designation |
Head Clinical Operations |
| Affiliation |
Scitus Pharma Services Private Limited |
| Address |
Scitus Pharma Services Private Limited 2 294 DRR Avenue AUDCO Nagar 2nd street Kattupakkam Poonamallee
Thiruvallur
TAMIL NADU
600056
India |
| Phone |
9994689336 |
| Fax |
|
| Email |
senthilkumar.k@scitusbiolab.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SD Rajendran |
| Designation |
Director and Head Operations |
| Affiliation |
Scitus Pharma Services Private Limited |
| Address |
Scitus Pharma Services Private Limited 2 294 DRR Avenue AUDCO Nagar 2nd street Kattupakkam Poonamallee
Thiruvallur
TAMIL NADU
600056
India |
| Phone |
9940306042 |
| Fax |
|
| Email |
sd.rajendran@scitusbiolab.com |
|
|
Source of Monetary or Material Support
|
| Novitium Pharma a subsidiary of ANI Pharmaceuticals INC 70 Lake Drive East Windsor NJ 08520 USA |
|
|
Primary Sponsor
|
| Name |
Novitium Pharma a subsidiary of ANI Pharmaceuticals INC |
| Address |
70 Lake Drive East Windsor NJ 08520 USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 23 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Urvi Panchal |
Aarvy Health care hospital |
Aarvy hospital sector-90
Gurgaon, Haryana -122505
Gurgaon
HARYANA |
8800827110
drurvi77@gmail.com |
| Dr Bhushan Madke |
Acharya Vinoba bhave rural hospital Datta Meghe Institute of Medical Sciences (DU) |
Sawangi (Meghe) Wardha 442004 Maharashtra India
Wardha
MAHARASHTRA |
7066887353
drbhushan81@gmail.com |
| Dr Abhishek Bhardwaj |
All India Institute of Medical Sciences |
Basni Industrial Area, Phase - 2, Jodhpur
Jodhpur
RAJASTHAN |
7063956224
dr.abhishekbhardwaj@gmail.com |
| Dr Jayanta Kumar Barna |
Calcutta School of Tropical Medicine |
108, Chittaranjan Avenue, Kolkata - 700073
Kolkata
WEST BENGAL |
8240862831
drjayantakumarbarua@gmail.com |
| Dr J Shankari |
Chettinad Super Speciality Hospital |
Rajiv gandhi Salai Kelambakkam Chennai
Chennai
TAMIL NADU |
9047020730
drshankarij@gmail.com |
| Dr M Asha |
Government Medical College and Govt. General Hospital (Old RIMSGGH) |
Srikakulam 532001 Andhra Pradesh India
Srikakulam
ANDHRA PRADESH |
7981258933
gghsrikakulam@gmail.com |
| Dr Mahendra M Kura |
Grant Govt. Medical College & Sir Hospital |
J.J. Marg, Nagpada, Mumbai Central, Mumbai
Mumbai
MAHARASHTRA |
9322593511
drkura@gmail.com |
| Dr ShankariJ |
H4U Clinic |
4/170, KR Building,First floor, Old Mahabalipuram Road Egattur,Tamil Nadu- 603103, India.
Kancheepuram
TAMIL NADU |
9047020730
drshankarij@gmail.com |
| Dr Rashmi Kumari |
JIPMER Puducherry |
JIPMER Gorimedu
Dhanvantary nagar post Puducherry 605006
Pondicherry
PONDICHERRY |
9489692199
rashmidermat@gmail.com |
| Dr Nanjundaswamy BL |
K R Hospital, Mysore Medical College |
K R Hospital, Attached to Mysore
Medical College and Research Institute,
Irwin Road- 570001, Mysuru, Karnataka. India
Mysore
KARNATAKA |
9448025219
dr.blnswami@gmail.com |
| Dr Patnala Guru Prasad |
King George Hospital |
Maharanipeta Visakhapatnam 530002 Andhra Pradesh India
Visakhapatnam
ANDHRA PRADESH |
9848022615
drpguruprasadresearch@gmail.com |
| Dr Rachita Dhurat |
L.T.M Medical College and L.T.M General Hospital |
Sulochana Shetty Road, Mumbai
Mumbai
MAHARASHTRA |
9870390057
rachitadhurat@yahoo.co.in |
| Dr Ishad Agarwal |
Lifeline Diagnostic Center cum Nursing Home |
4A, Wood Street, Kolkata - 700016
Kolkata
WEST BENGAL |
8100622846
ishad1984@gmail.com |
| Dr Shendkar Sonal Mahadev |
Lifepoint Multispecialty Hospital |
No.145/1,Mumbai Bangalore Highway,Near Hotel Sayaji, Wakad,
Pune- 411057,Maharashtra,lndia
Pune
MAHARASHTRA |
9960178611
shendkar.sonal82@gmail.com |
| Dr Uma Narayanamurthy |
Mahatma Gandhi Medical College and Research Institute Puducherry |
NH 45 A Pondy Cuddalore road Pillaiyarkuppam Puducheny 607 403
Pondicherry
PONDICHERRY |
9842329417
numa.lally@gmail.com |
| Dr Ashish Deshmukh |
Mahatma Gandhi Mission Medical College and Hospital |
Gate No 2 MGM Campus N-6 Cidco Aurangabad 431003
Aurangabad
MAHARASHTRA |
9422213292
ashish7557@gmail.com |
| Dr R Rajesh |
Meenakshi Medical College Hospital & Research Institute |
Meenakshi Medical College Hospital & Research Institute
Enathur, Kanchipuram - 631552
Kancheepuram
TAMIL NADU |
9994578989
drraje86@gmail.com |
| Dr Shabana Shaik |
Narayana Medical College and Hospital |
Chinthareddypalem Nellore 524003 AP India
Nellore
ANDHRA PRADESH |
9963541550
dr.sshabana@gmail.com |
| Dr Trishna Vaishali M |
Pondicherry Institute of Medical Sciences |
Ganapathychettikulam Puducherry 605014
Pondicherry
PONDICHERRY |
9840579316
trishpraveen@gmail.com |
| Dr Vinay K |
Postgraduate Institute of Medical education and Research, Chandigarh |
Post Graduate Institute of Medical Education & Research,
SECTOR -12, CHANDIGARH – 160012
Chandigarh
CHANDIGARH |
8872993222
vinay.keshavmurthy@gmail.com |
| Dr Harish Prasad B R |
Shetty’s Hospital |
Shetty’s Hospital
Plot no;11 & 12, 12th ‘F’ main,
Kaveri Nagar, Bommanahalli,
Bangalore – 560068, Karnataka, India
Bangalore
KARNATAKA |
8123851615
shettyshospital@gmail.com |
| Dr Murali Narasimhan |
SRM Medical College Hospital and Research Centre |
SRM Nagar Potheri Kattankulathur Chengalpattu (Dt) Chennai
Chennai
TAMIL NADU |
9840168717
muralin@srmist.edu.in |
| Dr Srinivas |
Udhbhava Hospital |
No 114, 100ft road,
Ittamadu,Banashankari 3rd stage,
Bangalore-560085
Bangalore
KARNATAKA |
9739006755
knppll@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 22 |
| Name of Committee |
Approval Status |
| Clinical Research Ethics Committee School of Tropical Medicine |
Not Applicable |
| Ethics Committee Narayana Medical College Hospital |
Approved |
| Hycare Super Speciality Hospital Ethics Committee |
Approved |
| IEC Intervention Studies JIPMER |
Not Applicable |
| IEC King George hospital |
Approved |
| IEC LIFELINE DIAGNOSTIC CENTER CUM NURSING HOME |
Not Applicable |
| Institute Ethics Committee Pondicherry Institute of Medical Sciences |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE , GGMC, MUMBAI Grant Govt Medical College JJ Road, JJ Hospital compound Mumbai |
Not Applicable |
| Institutional Ethics Committee for Human Research, Lokmanya Tilak Municipal Medical College (IEC-HR-LTMMC) |
Approved |
| Institutional Ethics Committee Govt. Medical College Govt.General Hospital Srikakulam |
Not Applicable |
| Institutional Ethics Committee of DMIMS Datta Meghe Institute of Medical Sciences Sawangi (Meghe) Wardha |
Approved |
| Institutional Ethics committee PGIMER |
Approved |
| Institutional Ethics Committee SRM Medical College Hospital and Research Centre |
Approved |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE All India Institute of Medical Sciences Basni Jodhpur Jodhpur |
Not Applicable |
| Institutional Human Ethics Committee Mahatma Gandhi Medical College Research Institute |
Approved |
| Lifepoint Research Ethics Committee |
Approved |
| Meenakshi medical college hospital & research committee |
Approved |
| MGM Human Ethics Committee |
Approved |
| Mysore medical college Institutional Ethics committee |
Approved |
| Shettys hospital ethics committee |
Approved |
| society for research welfare independent ethics committee |
Approved |
| SRI DURGAMBA INDEPENDENT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ketoconazole Shampoo - Placebo |
The shampoo is applied to the damp skin of the affected area and a wide margin surrounding this area. Lather and leave it for 05 minutes and rinse off with water. A single application on Day 01 at the subject’s home is sufficient |
| Intervention |
Ketoconazole Shampoo 2% For Topical Application |
The shampoo is applied to the damp skin of the affected area and a wide margin surrounding this area. Lather and leave it for 05 minutes and rinse off with water. A single application on Day 01 at the subject’s home is sufficient |
| Comparator Agent |
Ketoconazole Shampoo 2% For Topical Application |
The shampoo is applied to the damp skin of the affected area and a wide margin surrounding this area. Lather and leave it for 05 minutes and rinse off with water. A single application on Day 01 at the subject’s home is sufficient |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or non-pregnant, non-lactating female, with the age limit of ≥18 years to ≤65 years.
2. Subject able to communicate effectively and provide written informed consent.
3. Female subject of childbearing potential must NOT be pregnant or lactating at Visit 01 (negative urine pregnancy test).
4. Be either post-menopausal or surgically sterile, abstinent, or, if sexually active, willing to practice an effective method of birth control before entry and throughout the study.
5. Clinical diagnosis of Tinea Versicolor. Presence of infection with Malassezia furfur (Pityrosporum orbiculare or P. ovale) as confirmed by a positive KOH cellophane tape test (Annexure 04) showing the characteristic “spaghetti and meatballs†appearance of the round budding yeast cells and short hyphae.
6. Sum of clinical signs and symptoms score of target lesion at least 4; in addition, target lesion must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for either pruritis or scaling.
7. Subjects willing to abide by the study requirements and also give consent to take photos of the infected area (s).
|
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating or planning to become pregnant during the study period.
2. Use of Antipruritics, including Antihistamines, within 72 hours prior to entry into the study.
3. Use of topical Corticosteroid, Antibiotics or Antifungal therapy within 02 weeks prior to entry into the study.
4. Use of systemic (e.g., oral or injectable) Corticosteroid, Antibiotics or Antifungal therapy within 01 month prior to entry into the study.
5. Use of oral Terbinafine or Itraconazole within 02 months prior to entry into the study.
6. Use of immunosuppressive medication or radiation therapy within 03 months prior to entry into the study.
7. Use of any other topical products applied to the target site, Systemic (e.g., oral or injectable) Antibiotics or Antifungals, Systemic Corticosteroid, Antipruritics, including Antihistamines, within 24 hours of study visits.
8. History of dermatophyte infections unresponsive to systemic or topical antifungal drugs
9. History of alcohol or other substance abuse within the last one year.
10. Known hypersensitivity to Ketoconazole, other Imidazoles or to any component of the formulation, particularly sulfites.
11. Receipt of any drug as part of a research study within 30 days before Visit 01.
12. Previous participation in a similar study.
13. Institutionalized subject.
14. Inability to understand the requirements of the study and the relative information or are unable or unwilling to comply with the study protocol.
15. Any other condition of the subject, which, in the opinion of the investigator, which is likely to interfere with the study treatment and assessments.
16. Other severe acute or chronic medical or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into the trial
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
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Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• To demonstrate clinical endpoint bioequivalence of Ketoconazole Shampoo 2% For Topical Application of Novitium Pharma (a subsidiary of ANI Pharmaceuticals INC.) with Ketoconazole Shampoo 2% For Topical Application of Perrigo in subjects with Tinea Versicolor.
• To evaluate the superiority of Ketoconazole Shampoo 2% For Topical Application and Ketoconazole Shampoo 2% For Topical Application of Perrigo over placebo in subjects with Tinea Versicolor.
|
• To demonstrate clinical endpoint bioequivalence of Ketoconazole Shampoo 2% For Topical Application of Novitium Pharma (a subsidiary of ANI Pharmaceuticals INC.) with Ketoconazole Shampoo 2% For Topical Application of Perrigo in subjects with Tinea Versicolor.
• To evaluate the superiority of Ketoconazole Shampoo 2% For Topical Application and Ketoconazole Shampoo 2% For Topical Application of Perrigo over placebo in subjects with Tinea Versicolor.
in 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety and tolerability of Investigational Products |
Safety will be assessed for total study duration 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="535"
Sample Size from India="535"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="535" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
05/11/2022 |
| Date of Study Completion (India) |
31/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="3" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Randomized, Double Blind, Three- arm, Placebo Controlled, Parallel Design, Multi-Center, Clinical Endpoint Bioequivalence Study in Adult Male and Female (non-pregnant & non-lactating) Subjects with Tinea Versicolor. The primary objective of this study is to demonstrate clinical endpoint bioequivalence between the test and reference products and to test the superiority of the two active treatments to Placebo in human adult Male and Female (non-pregnant & non-lactating) Subjects with Tinea Versicolor. The secondary objective is to assess the safety of Investigational Products in human adult Male and Female (non-pregnant & non-lactating) Subjects with Tinea Versicolor.
|