CTRI/2024/01/061161 [Registered on: 05/01/2024] Trial Registered Prospectively
Last Modified On:
18/10/2024
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Other
Public Title of Study
A Bioequivalence study to Evaluate the Efficacy and Safety of Ketoconazole Shampoo in Subjects with Tinea Versicolor.
Scientific Title of Study
A Multicenter, Randomized, Double-Blind, Three-Arm, Placebo-Controlled, Parallel Design, Study to Evaluate the Efficacy and Safety of Ketoconazole 2% Shampoo of Encube Ethicals Private Limited, India with Ketoconazole Shampoo, 2% of Padagis (Perrigo) Allegan, MI 49010 in Subjects with Tinea Versicolor.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
Protocol No.: C2A03362 Version: 01 Date: 01 Aug 2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dharmesh Domadia
Designation
Vice President Global Clinical Operation
Affiliation
Cliantha Research Limited
Address
Cliantha Research Ltd., Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382 210, Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
9879590828
Fax
Email
ddomadia@cliantha.com
Details of Contact Person Scientific Query
Name
Dr Ankesh Barnwal
Designation
Associate Director- II– Clinical Trial Medical Services
Affiliation
Cliantha Research Limited
Address
Cliantha Research Ltd., Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382 210, Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
07966219500
Fax
Email
abarnwal@cliantha.com
Details of Contact Person Public Query
Name
Mr Devesh Verma
Designation
Associate Director-I - Clinical Trials
Affiliation
Cliantha Research Limited
Address
Cliantha Research Ltd., Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382 210, Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
9712908404
Fax
Email
dverma@cliantha.com
Source of Monetary or Material Support
Encube Ethicals Private Limited,
Unit No. 24, Steelmade Industrial Estate, Marol Village, Andheri (E), Mumbai – 400059, Maharashtra, India.
Primary Sponsor
Name
Encube Ethicals Private Limited
Address
Unit No. 24, Steelmade Industrial Estate, Marol Village, Andheri (E),
Mumbai – 400 059 Maharashtra, India.
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Cliantha Research Limited
TP 86, FP 28-1, Off S P Ring Road, Sarkhej Ahmedabad
Sixth Floor, Clinical Research Department, Besides Nilamkunj Society, Nr. Gokulnathji Haveli Mira Cinema Cross Road, Bhairavnath, Shah Alam Rd, Maninagar, Ahmedabad - 380028, Gujarat, India. Ahmadabad GUJARAT
8866220033
bhavarthkalaria@gmail.com
Dr V Revathi
Government Medical College & Government General Hospital
OPD No. 16, 3rd Floor, Department of Dermatology, Srikakulam - 532001, Andhra Pradesh, India Srikakulam ANDHRA PRADESH
9908066043
drrevathivggh@gmail.com
Dr Bangaru H
K R Hospital Attached to Mysore Medical College and Research Institute
K R Hospital, Attached to Mysore Medical College and Research Institute, Irwin Road - 570001 , Mysuru, Karnataka, India.
Mysore KARNATAKA
9886789231
drbangaruskin@gmail.com
Dr Patnala Guru Prasad
King George Hospital
Clinical research Room, Department of Dermatology, Andhra Medical College, Maharanipeta, Visakhapatnam - 530002, Andhra Pradesh, India
Visakhapatnam ANDHRA PRADESH
9848022615
drpguruprasadresearch@gmail.com
Dr Gnanasuriyan R
Mahatma Gandhi Medical College Research Institute
Department of Dermatology, Venereology & Leprosy (DVL), Clinical trial and training centre, 1st Floor, Hospital Block, Pondicherry - Cuddalore ECR Main Road, Pillayarkuppam, Puducherry- 607402, India
Pondicherry PONDICHERRY
Panimalar Medical College Hospital & Research Institute
Room No. 468, 3rd Floor, Division of Clinical Research, Varadharajapuram, Poonamallee, Chennai - 600123, Tamil Nadu, India Chennai TAMIL NADU
9629048549
perumd88@gmail.com
Dr Dhwani Makwana
Parth Hospital
E 405-4, 407-411, Fourth Floor Galaxy Arcade, Near Galaxy Cinema, Naroda, Gujarat 382330, India Ahmadabad GUJARAT
9662133253
dhwanimakwanacr722@gmail.com
Dr Sonal Shendkar
Saikrupa Hospital
Third Floor, Clinical Research Department, plot 4/14/B, sector 34, Renuka corner, Tapkir chock, Pune - 411033, Maharashtra, India Pune MAHARASHTRA
9960178611
drsonalshendkar@gmail.com
Dr Neela Patel
Sheth L.G Municipal General Hospital
Room No. 5, Second Floor, Dermatology Department, Near Rambaug, Maninagar- 380008, Ahmedabad, Gujarat, India Ahmadabad GUJARAT
9824058208
patelneela1974@yahoo.co.in
Dr Swati Engineer
Shraddha Hospital
Second Floor, Clinical Research Department, Vaibhav Complex, Opp. Civil Hospital, Kalol - 382721, Gujarat, India.
Gandhinagar GUJARAT
9824021254
srengineer6@gmail.com
Dr Shyamal Balki
Shree Hospital and Critical care center
Third Floor, Research Department, Nagpur - 440009, Maharashtra, India
Nagpur MAHARASHTRA
9730310367
drshyamalb@gmail.com
Dr Nikhil Kajale
Shree Siddhivinayak Maternity & Nursing Home
Third Floor, Clinical Research Department, Unity Campus, 2nd floor, Opp. KTHM College, Gangapur Road, Nashik 422002, Maharashtra, India
Nashik MAHARASHTRA
9619841393
niks_kajale@rediffmail.com
Dr Murali Narasimhan
SRM Medical college Hospital & Research Centre
3rd & 4th floor, D Block, Centre for Clinical Pharmacology, SRM Nagar, Potheri, Kattankulathur, Chengalpattu, Tamil Nadu - 603203, India
Kancheepuram TAMIL NADU
Each subject will use the assigned study product as instructed on a single occasion on the day of randomization [Day 0 (+1 day)]. Caregiver can help subject (ifrequired) for study drug application. Drug application can be done at study site or home as per subject’s convenience. Following instructions will be given to the subjects:
• Apply the shampoo to the damp skin of the affected area and a wide margin surrounding this area.
• Lather, leave in place for 5 minutes, and then rinse off with water.
• Avoid study product contact with eye.
Intervention
Ketoconazole 2% Shampoo
Each subject will use the assigned study product as instructed on a single occasion on the day of randomization [Day 0 (+1 day)]. Caregiver can help subject (ifrequired) for study drug application. Drug application can be done at study site or home as per subject’s convenience. Following instructions will be given to the subjects:
• Apply the shampoo to the damp skin of the affected area and a wide margin surrounding this area.
• Lather, leave in place for 5 minutes, and then rinse off with water.
• Avoid study product contact with eye.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
Subject will be eligible for inclusion in this study only if all of the following criteria apply:
1. Male or non-pregnant, non-lactating female subjects of 18 to 65 years of age.
2. Subject with a clinical diagnosis of tinea versicolor and both of the following:
a. A combined severity score of at least 4, with at least one of the following signs and symptoms rated at least 2, using the following scale:
Signs/symptoms Scale
desquamation/scaling - 0 equals to absent
pruritus/itching - 1 equals to mild
erythema - 2 equals to moderate & 3 equal to severe
b. Presence of infection with Malassezia furfur (Pityrosporum orbiculare or P. ovale) confirmed by a positive KOH cellophane tape test showing the characteristic “spaghetti and meatballs†appearance of the round budding yeast cells and short hyphae.
3. Subject able to understand the investigational nature of this study and provide written informed consent prior to screening.
4. Female of childbearing potential, have a negative urine pregnancy test and willing to use an acceptable form of birth control including abstinence during the study.
5. Able to comply with study requirements in the opinion of Investigator.
6. Agree not to take a shower, bath, or swim, for at least 4 hours before all study visits
7. Agree to use only non-medicated shampoos and soaps during the entire study period.
ExclusionCriteria
Details
Subject will not be eligible for inclusion in this study if any of the following criteria apply:
1. Has recent history or evidence of other fungal infections, including oral, vaginal or chronic mucocutaneous candidiasis, systemic fungal infections or dermatophyte infections that may interfere with assessment of tinea versicolor.
2. Use of any systemic antifungals (oral or injectable), corticosteroids or
immunosuppressive drugs within 30 days prior to randomization.
3. Any eye disease that could be irritated by shampoo.
4. Subject with known history of uncontrolled diabetes (based on HbA1c report [greater than 7%] within last 3 months) or expected change in anti-diabetic medication during study or within last 1 month.
5. Use of any prescription or over the counter (OTC), topical antifungal, anti-pruritus, corticosteroid, selenium sulfide or zinc pyrithione preparations within 14 days prior to randomization or used antihistamines that may interfere with the subjects ability to experience cutaneous sensations within 24 hours prior to randomization, unless on a stable dose of antihistamine for at least 30 days.
6. Any known hypersensitivity or allergy to ketoconazole or any other inactive ingredients used in the study products or other imidazole antifungals or other shampoos, soaps or cosmetics.
7. Treatment for tinea versicolor within the past six months that has been unresponsive to prescription topical or oral antifungals.
8. History of alcohol or other substance abuse within the last one year.
9. Any other clinical investigation using experimental drug within past 30 days of prior to randomization.
10. Institutionalized subject.
11. Live in the same household as currently enrolled subject or in the same household of a subject who has previously participated in the study.
12. Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities or on any medication 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 judgment of the Investigator, would make the subject inappropriate for entry into the trial.
13. Inability to understand the requirements of the study and the study information or is unable or unwilling to comply with the study protocol.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Other
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
1. To evaluate bioequivalence (with clinical endpoint) of test product (Ketoconazole 2% Shampoo) of Encube Ethicals Private Limited, India with reference product (Ketoconazole Shampoo, 2%) of Padagis (Perrigo) Allegan, MI 49010 in subjects with tinea versicolor.
2. To evaluate superiority of test and reference product with placebo in subjects with tinea versicolor.
4 Week(±4 days)
Secondary Outcome
Outcome
TimePoints
1. To assess safety and tolerability of study treatments.
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
4 Week(±4 days)
Target Sample Size
Total Sample Size="425" Sample Size from India="425" Final Enrollment numbers achieved (Total)= "425" Final Enrollment numbers achieved (India)="425"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
A study is A Multicenter, Randomized, Double-Blind, Three-Arm, Placebo-Controlled,
Parallel Design study. This clinical trial intended to Evaluate
the Efficacy and Safety of Ketoconazole 2% Shampoo of Encube Ethicals Private
Limited, India with Ketoconazole Shampoo, 2% of Padagis (Perrigo) Allegan, MI
49010 in Subjects with Tinea Versicolor.