CTRI/2024/10/075933 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On:
02/04/2026
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Other
Public Title of Study
Clinical endpoint trial to evaluate the bioequivalence of Tapinarof cream 1%
Scientific Title of Study
A Randomized, multicenter, double-blind, parallel group, three-arm, placebo-controlled trial to evaluate the bioequivalence of Tapinarof cream 1 Percent of Mylan Laboratories Ltd versus VTAMA® (Tapinarof cream 1 Percent, Dermavant Sciences Inc.) using the clinical endpoint in patients with plaque psoriasis.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
TAPI-CRZ-3001 Version 1.0 Date: 22-Jul-2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dharmesh Domadia
Designation
Vice President - Global Clinical Operations
Affiliation
Cliantha Research Limited
Address
TP 86, FP 28/1,
Off S.P. Ring Road, Sarkhej,
Ahmedabad-382210,
Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
912717698500
Fax
Email
ddomadia@cliantha.com
Details of Contact Person Scientific Query
Name
Dr Ankesh Barnwal
Designation
Associate Director - II
Affiliation
Cliantha Research Limited
Address
TP 86, FP 28/1,
Off S.P. Ring Road, Sarkhej,
Ahmedabad-382210,
Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
07966219500
Fax
Email
abarnwal@cliantha.com
Details of Contact Person Public Query
Name
Mr Devesh Verma
Designation
Assosiate Director II
Affiliation
Cliantha Research Limited
Address
TP 86, FP 28/1,
Off S.P. Ring Road, Sarkhej,
Ahmedabad-382210,
Gujarat, India
All India Institute of Medical Sciences, New Delhi
Room No. 4064, Teaching Block, All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 New Delhi DELHI
GMERS Medical College and Civil Hospital, Sola, Nr. Gujarat Highcourt, SG Highway, Ahmedabad - 380060 Ahmadabad GUJARAT
9227222221
drkbpatel66@gmail.com
Dr Revathi Vavilapalli
Govt. Medical College & Govt.General Hospital
OPD R. No. 16 located at 3rd floor, Dept of Dermatology, Beside FM Ward, Government Medical College & Govt. General Hospital (Old RIMSGGH), Srikakulam-532001, Andhra Pradesh
Srikakulam ANDHRA PRADESH
IGIMS, Department of skin and VD, Sheikhpura, Patna, Bihar - 800014 Patna BIHAR
7764049225
sinhaderma@gmail.com
Dr Bangaru H
K. R Hospital Mysore Medical College and Research Institute
K.R. Hospital, Mysore Medical College & Research Institute, Irwin Road, Mysore - 570001, Karnataka
Mysore KARNATAKA
9886789231
drbangaruskin@gmail.com
Dr Anjeeta Dhawan
Maharaja Agrasen Hospital
Maharaja Agrasen Hospital, West Punjabi Bagh, New Delhi - 110026
New Delhi DELHI
9810631823
anjeetadr@gmail.com
Dr Mithin Kumar B
Mahatma Gandhi Medical College and Research Institute
R. No. 115, located at 1st floor, F-Block of hospital, Mahatma Gandhi Medical College and Research Institute, Cuddalore Rd, ECR, Pillayarkuppam, Puducherry - 607402
Pondicherry PONDICHERRY
8754874851
bmithinkumar12@gmail.com
Dr Amit Shekhar
MLN Medical College Associate with Swaroop Rani Nehru Hospital
Room Number 3/15, 3rd Floor, Derma Dept of Hospital building, Swaroop Rani Nehru Hospital, George Town, Civil Lines, Prayagraj - 211001, Uttar Pradesh, India Allahabad UTTAR PRADESH
Institutional Ethics committee for biomedical and health research
Approved
Institutional Ethics Committee Sarvodaya Hospital And Research Centre
Approved
Institutional Ethics Committee Sri Ram Hospital And Research Centre Pvt. Ltd.
Approved
Institutional Ethics Committee, MLN Medical College
Approved
Institutional Ethics Committee, SGRR
Approved
Institutional Human Ethics Committee (IHEC)
Approved
Jivanrekha Institutional Ethics Committee
Approved
Maharaja Agrasen Hospital Institutional Ethics Com
Approved
Ojas Multispeciality Hospital Ethics Committee
Approved
Parth institutional ethics committee
Approved
Riddhi Medical Nursing Home IEC
Approved
Sir Ganga Ram Hospital Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: L40||Psoriasis,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Tapinarof cream 1%
(dose) once daily for 12 weeks
Comparator Agent
VTAMA® (Tapinarof cream 1%,)
(dose) once daily for 12 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
1. Male or non-pregnant, non-lactating females aged between 18 to 75 years with a clinical diagnosis of stable (at least 6 months) plaque psoriasis involving 3 to 20% body surface area (BSA)
2. A PGA score of 2 (mild), 3 (moderate), or 4 (severe)
3. Female participants should have been postmenopausal for at least 1 year
ExclusionCriteria
Details
1. Females who are pregnant, breast feeding, or who wish to become pregnant during the trial period.
2. Current diagnosis of unstable forms of psoriasis
3. Other inflammatory skin disease in the treatment area that may confound the evaluation of the plaque psoriasis
4. Current immunosuppression
5. Concurrent conditions or history of other inflammatory, infectious and immunocompromised diseases
6. Current or chronic history of liver disease, known hepatic or biliary abnormalities
7. Current or a history of cancer within 5 years,
8. Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas
9. History of hypersensitivity to any component of the test product or reference listed drug.
10. A history of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator’s opinion, may interfere with the participants participation in the trial and ability to understand and give informed consent.
11.Planned surgery or hospitalization (anticipated to last > 72 hours) during the trial.
12.Any other medical condition that, in the opinion of the Investigator, renders the participants unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the participant.
13. Clinically significant abnormalities in ECG or Screening laboratory parameters
14. Non-cooperation with clinical trial staff.
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
Proportion of participants with treatment success defined as a Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at the end of treatment.
12 weeks
Secondary Outcome
Outcome
TimePoints
To compare the body sites and size of treatment area.
To assess the safety and tolerability of trial treatments by reported adverse events.
12 weeks
Target Sample Size
Total Sample Size="450" Sample Size from India="450" Final Enrollment numbers achieved (Total)= "450" Final Enrollment numbers achieved (India)="450"
Phase of Trial
N/A
Date of First Enrollment (India)
23/12/2024
Date of Study Completion (India)
20/03/2026
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="1" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Completed
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
·This will be a
Randomized, multicenter, double-blind, parallel group, three-arm,
placebo-controlled trial with primary objective to determine the bioequivalence
(with clinical endpoint) of Mylan’s Tapinarof cream, 1% with the reference
listed drug, VTAMA (Tapinarof 1%, Dermavant Sciences Inc.), and superiority of
the Test and RLD with placebo.
·Sample size of
the study will be approximately 450 participants; male or non-pregnant, non-lactating
females aged between 18 to 75 years with a clinical diagnosis of stable (at
least 6 months) plaque psoriasis involving 3 to 20% body surface area (BSA),
not including the face, scalp, groin, palms, and soles in the BSA calculation
for a period of 16 weeks.
·Participants will receive either Mylan’s Tapinarof Cream (n = 180), RLD
(VTAMA cream 1%; n = 180) or Placebo (n = 90), once daily for 84 days (12
weeks). Participants will take the trial drug home and self-administer trial
drug or have caregiver apply, if necessary, to affected areas once daily. At
clinic visits, trial drug will be applied after safety and efficacy assessments
have been conducted.
·At each contact
with the participant, the investigator will seek information on adverse events
by different safety assessments like physical examination, vital signs and
clinical laboratory investigations etc.
·Telephonic
follow-ups are scheduled between visits to assess AEs and concomitant
medications, to review trial drug application procedures, and to confirm
participant’s continued participation in the trial.
End of the Study (EOS) and Follow-up safety assessment
will be done two weeks post last dose of trial treatment received during the
randomized treatment period.