This is a placebo-controlled trial to evaluate the clinical equivalence of Tapinarof cream 1% of Dr Reddy’s Laboratories Ltd versus VTAMA® (Tapinarof cream 1%, Dermavant Sciences Inc.) using the clinical endpoint in patients with plaque psoriasis.
Scientific Title of Study
A Randomized, multicenter, double-blind, parallel group, three-arm, placebo-controlled trial to evaluate the clinical equivalence of Tapinarof cream 1% of Dr Reddy’s Laboratories Ltd versus VTAMA® (Tapinarof cream 1%, Dermavant Sciences Inc.) using the clinical endpoint in patients with plaque psoriasis.
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Naman Shah
Designation
Senior General Manager
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Plot No. 38, Survey no. 388, Near Silver Oak Club, S.G. Highway, Gota, Ahmadabad, Gujarat, India.
Ahmadabad GUJARAT 382481 India
Phone
07940202389
Fax
07940202021
Email
namanshah@lambda-cro.com
Details of Contact Person Scientific Query
Name
Dr Jogesh Mahajan
Designation
Senior Vice President
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Plot No. 38, Survey no. 388, Near Silver Oak Club, S.G. Highway, Gota, Ahmadabad, Gujarat, India.
Ahmadabad GUJARAT 382481 India
Phone
07940202288
Fax
07940202021
Email
jogeshmahajan@lambda-cro.com
Details of Contact Person Public Query
Name
Dr Jogesh Mahajan
Designation
Senior Vice President
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Plot No. 38, Survey no. 388, Near Silver Oak Club, S.G. Highway, Gota, Ahmadabad, Gujarat, India.
GUJARAT 382481 India
Phone
07940202288
Fax
07940202021
Email
jogeshmahajan@lambda-cro.com
Source of Monetary or Material Support
Dr. Reddy’s Laboratories Ltd.
Integrated Product Development Organisation,
Innovation plaza, Survey No: 42, 45 and 46,
Bachupally village, Bachupally Mandal
Medchal Malkajgiri District 500 090, Telangana, India
Primary Sponsor
Name
Dr. Reddy’s Laboratories Ltd.
Address
Integrated Product Development Organisation,
Innovation plaza, Survey No: 42, 45 and 46,
Bachupally village, Bachupally Mandal
Medchal Malkajgiri District 500 090, Telangana, India
Department of Clinical research, Room No. NA, Opp, Government Polytechnic College, near Panjarapole, Cross road, L Colony, Ambawadi, Ahmedabad, Gujrat-380006
Ahmadabad GUJARAT
9898105539
anshulwarman@rediffmail.com
Dr Shivani Bansal
All India Institute of Medical Sciences Bathinda
Department of Clinical research, Room No. NA, Mandi Dabwali Road, Jodhpur Romana, Punjab, India-151001
Bathinda PUNJAB
9464739943
drshivani.derm@gmail.com
Dr Neetu Sidana
Apex Hospital Pvt. Ltd.
Department of Clinical research, Room No. NA, S P 4 and 6, Malviya Industrial Area, Malviya Nagar, Jaipur-302017, Rajasthan, India
Jaipur RAJASTHAN
9829335095
drneetusidana95@gmail.com
Dr Vaibhav Kalambe
Asian Institute of Medical Sciences
Department of Clinical research, Room No. NA, P/72, Milap Nagar, MIDC, Dombivli (E), Maharashtra, India-421203
Mumbai MAHARASHTRA
9167551456
drvaibhavkalambe@gmail.com
Dr Kranti
Department of Skin VD, Indira Gandhi Institute of medical Sciences(IGIMS)
Department of Clinical research, Room No. NA, Department of Skin VD, Indira Gandhi Institute of medical Sciences(IGIMS), Sheikhpura, Patna, Bihar- 800014 India
Patna BIHAR
8969953194
krantijaykar@gmail.com
Dr Kishan Ninama
Dhiraj Hospital
Department of Clinical research, Room No. NA, SBKS MI & RC Sumandeep Vidyapeeth Deemed to be University, At & Po Piparia, Ta Waghodia, Dist Vadodara-391760
Vadodara GUJARAT
96019876566
drkishanninama.dermatologist@gmail.com
Dr Hital Patel
DHS Multispeciality Hospital
Department of Clinical research, Room No. NA, Vastrapur Lake, Himalaya Mall Link Road, Sunrise Park , Vastrapur, Ahmedabad-380054
Ahmadabad GUJARAT
9824601777
skinconsultation@gmail.com
Dr Shilpashree P
Dr. B R Ambedkar Medical College
Department of Clinical research, Room No. NA, 24, Shampura Main Road, Kadugondanahalli, Benglore-560045
Bangalore KARNATAKA
9663384483
drshilpark@gmail.com
Dr Sonam Singh
Dr. Sachans Skin, Hair and Cosmetic Clinic
Department of Clinical research, Room No. NA, 129/E Opp Archis School, Shyam Nagar, Kanpur-208013, India
Kanpur Dehat UTTAR PRADESH
9196209640
sonam.sachan@gmail.com
Dr Sakshi Midha
Excel care Hospital
Department of Clinical research, Room No. NA, Excel care Hospital, 103 Sanjay Nagar A, Joshi Marg, Kalwar Road, Jhotwara, Jaipur-302012
Jaipur RAJASTHAN
9001711113
sakshi.midha@gmail.com
Dr Rajeev Kumar
Gangasheel Advanced Medical Research Institute
Department of Clinical research, Room No. NA, C-17,Deen Dalay Puram, Bareilly, Uttar Pradesh,243122
Bareilly UTTAR PRADESH
7906325361
dr.rk25@gmail.com
Dr Rajkumar Kothiwala
Jawahar Lal Nehru Medical College
Department of Clinical research, Room No. NA, Jawahar Lal Nehru Medical College, Kala Bagh, Ajmer-305001
Ajmer RAJASTHAN
9414118811
doctor.rajkumark@gmail.com
Dr Ghanshyam Vinod
Jupiter Hospital and research Center
Department of Clinical research, Room No. NA, Sun pharma atladra road opposite icai
bhavan , atladara Vadodara Vadodara Gujarat- 390012 India
Vadodara GUJARAT
9824488194
dr.ghanshyam.vinodnm@gmail.com
Dr Nandita Patel
Kiran Hospital Multi super speciality Hospital and Research centre
Department of Clinical research, Room No. NA, Nr. Sumul Dairy, Surat, Gujarat-395004, India
Surat GUJARAT
9730840004
drnanditakpatel@gmail.com
Dr Kinjal Mistry
Kkasturi Medicare Pvt. Ltd.
Department of Clinical research, Room No. NA, Harshniketan,Gaondevi Road, Behind Navrang Hotel,Bhayandar West, Dist-Thane, Maharashtra, India-40110
Thane MAHARASHTRA
9022727123
drkinjalmistry04@gmail.com
Dr Bhavik Bhavsar
Lavanya Skin Clinic and Laser Centre
Department of Clinical research, Room No. NA, 303, Aishwarya Complex, Opp. Shell Petrol Pump, Jawahar Chawk, Maninagar, Ahmedabad,380008 Ahmadabad GUJARAT
9825953263
bhavikbhavsar78@gmail.com
Dr Sonal Shendkar
Lifepoint Multispeciality hospital
Department of Clinical research, Room No. NA, Clinical Research Department ,3rd floor, 145/1, Mumbai-Bangalore Highway, Near Highway, Near Hotel sayaji , Wakad, Pune-411075
Pune MAHARASHTRA
9960178611
shendkar.sonal82@gmail.com
Dr Monika Gowda
Medstar Speciality Hospital
Department of Clinical research, Room No. NA, 641/17/1/3, Kodigehalli Main road, Sahakarnagar, Bangalore-560092, Karnataka, India
Bangalore KARNATAKA
9538880387
drmonikagowda.medstar@gmail.com
Dr Ruchir Shah
NEO Digital Skin Clinic
Department of Clinical research, Room No. NA, 3rd Floor,Gurukrupa Complex , Near Mehta Petrol pump, Gidhar Nagar, Himatnagar, Gujrat-383001
Sabar Kantha GUJARAT
9904079691
drruchirshah.dermatologist@gmail.com
Dr Mamta Patil
Ojas Multispeciality Hospital,
Department of Clinical research, Room No. NA, Sr no 203/1, Bhondave Chock, D.Y Patil College Road, Ravet, Pune-412101
Pune MAHARASHTRA
7738927929
dr.mamta.ojas@gmail.com
Dr Manjunath Shenoy M
Omega Hospital
Department of Clinical research, Room No. NA, Mahaveer Circle, Kankanady, Mangalore-57500, Karnataka, India
Dakshina Kannada KARNATAKA
9845009976
manjunathshenoy.dermatology@gmail.com
Dr Stuti Mahajan
Raneshwar Multispeciality Hospital
Department of Clinical research, Room No. NA, A-4 Parshaw Nagar Society, Vasna Road, Before vasna, Ravi park society, Saiyed Vasna, Vadodara-390015
Vadodara GUJARAT
9727752212
stutimahajangreat@yahoo.com
Dr Nitin Wathore
Renukai Critical Care & Multispeciality Hospital
Department of Clinical research, Room No. NA, Behind LIC Office, Bafna Road,, Nanded-431602, Maharshtra, India
Nanded MAHARASHTRA
9727706126
drnitin.research@gmail.com
Dr Saswati Halder
School of Tropical Medicine
Department of Clinical research, Room No. NA, 108, Chittranjan Avenue Calcutta Medical College, college square, Kolkata West Bengal, India
Kolkata WEST BENGAL
7980669705
saswatihalder32@gmail.com
Dr Chetan Lalseta
Shree Giriraj Multispeciality Hospital
Department of Clinical research, Room No. NA, 150 Feet ring road, 27, Navjyot park Main road, Rajkot-360005, Gujrat, India
Rajkot GUJARAT
9825199585
chetanlalseta@gmail.com
Dr Zafar Abbas Chaudhary
Shree Krishna Medicare Hospital And ICU
Department of Clinical research, Room No. NA, 9/617, Ground Floor, Mehul Park, B/H GD Modi College , Jampura Anandnagar Hway, Palanpur, Banaskantha, Gujarat-385001, India
Banas Kantha GUJARAT
B.T Savani Kidney Hospital Ethical Committee, Dr. Chetan Lalseta
Approved
Clinical Research Ethics Committee, School of Tropical Medicine, Kolkata, Dr. Saswati Halder
Approved
Dr. B R Ambedkar Medical College and Hospital Institutional Ethics Committee, Dr. Shilpashree P.
Approved
Ethics committee Atmaram Child Care and Critical Care, Dr. Sonam Singh
Approved
Institutional Ethics Committee AIIMS Bathinda, Dr. Shivani Bansal
Submittted/Under Review
Institutional Ethics Committee sardarmal Khandaka Memorial Hospital, Dr. Sakshi Midha
Approved
Institutional Ethics Committee SV Sumandeep Vidyapeeth, Dr. Kishan Ninama
Approved
Institutional Ethics Committee, Dr. Kranti
Approved
Institutional Ethics Committee, Dr. Neetu Sidana
Approved
Institutional Ethics Committee, Dr. Rajeev Kumar
Approved
Institutional Ethics Committee, Dr. Rajkumar Kothiwala
Approved
IRB Raneshwar Multispeciality Hospital, Dr. Stuti Mahajan
Approved
Jupiter Hospital & Research Center, Institutional Ethics Committee, Dr. Ghanshyam Vinod
Approved
Keshav Psychiatric Hospital Institutional Ethics Committee, Dr. Ruchir Shah
Approved
Kiran Hospital Ethics Committee, Dr. Nandita Patel
Approved
Krishna Ethics Committee, Dr. Zafar Abbas Chaudhary
Approved
lifepoint research ethics Committee, Dr. Sonal Shendkar
Approved
Medstar Speciality Hospital Ethics Committee, Dr. Monika Gowda
Approved
Netaji Polyclinic Institutional Ethics Committee, Dr. Bhavik Bhavsar
Approved
Ojas Multispeciality Hospital Ethics Committee, Dr. Mamta Patil
Approved
Omega Ethical Committee, Dr. Manjunath Shenoy M
Submittted/Under Review
Renukai Institutional Ethics Committee, Dr. Nitin Wathore
Approved
Sangini Hospital Ethics Committee, Dr. Hital Patel
Approved
Shah Lifeline Hospital And Heart Institute Ethics Committee, Dr. Kinjal Mistry
Approved
Suraksha Ethics Committee, Dr. Vaibhav Kalambe
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
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
Placebo (vehicle) cream
Unit dose strength: 60-gram tube, Route of administration: Topical, duration: 12 weeks, Dosing instruction: Once daily topical application of thin layer to affected areas
Intervention
Tapinarof 1% cream
Unit dose strength: 1 percentage (10 mg per gram) per 60-gram tube, Route of administration: Topical, Duration: 12 weeks, Dosing instruction: Once daily topical application of thin layer to affected areas
Comparator Agent
VTAMA® (Tapinarof cream 1%)
Unit dose strength: 1 percentage (10 mg per gram) per 60-gram tube, Route of administration: Topical, Duration: 12 weeks, Dosing instruction: Once daily topical application of thin layer to affected areas
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1) Adult Human trial participants 18 to 65 years of age (both inclusive).
2) Trial participants with Clinical diagnosis of plaque psoriasis and stable disease for at least 6 months prior to the study.
3) Trial participants with a diagnosis of plaque psoriasis as evidenced by Body surface area (BSA) involvement greater than or equal to 3 percentage and less than or equal to 20 percentage (the participants face, scalp, groin, palms, and soles should be excluded from the percent of total BSA (percentage BSA) calculations).
4) A Physicians Global Assessment (PGA) score of 2 (mild), 3 (moderate) or 4 (severe) at screening.
5) Participant must be willing to refrain from using all other topical plaque psoriasis products during the 12 week treatment period, other than the investigational product.
6) Females of childbearing potential must have a negative serum pregnancy test at the Screening.
7) Females of child-bearing potential and male trial participants who are engaging in sexual activity with females of child-bearing potential that could lead to pregnancy must use at least 1 of the following adequate birth control methods while on study and for 4 weeks after the last exposure to investigational product. Acceptable contraception methods are: Male partner with vasectomy, OR Male condom AND partner use of 1 of the contraceptive options below: i) Spermicide
ii) Contraceptive subdermal implant that meets effectiveness criteria including a less than 1 percentage rate of failure per year, as stated in the product label.
iii) Intrauterine device or intrauterine system that meets effectiveness criteria including a less than 1 percentage rate of failure per year, as stated in the product label.
iv) Oral contraceptive, either combined or progestogen alone.
v) Injectable progestogen
vi) Contraceptive vaginal ring.
8) Capable of giving written informed consent, as applicable, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF); written informed consent must be obtained prior to any study related procedures.
ExclusionCriteria
Details
1) Females who are pregnant, breast feeding, or who wish to become pregnant during the study period
2) Current diagnosis of unstable forms of psoriasis in the treatment area, including guttate, erythrodermic, exfoliative or pustular psoriasis
3) Other inflammatory skin disease in the treatment area that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis)
4) Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas, which could interfere with the rating of efficacy parameters
5) History of hypersensitivity to any component of the test product or reference standard
6) Current immunosuppression
7) Use within one month or within 5 half-lives (whichever is longer) prior to baseline of: (i) systemic steroids, (ii) systemic antibiotics, (iii) systemic antipsoriatic treatment, (iV) psoralen plus ultraviolet A (PUVA) therapy, (v) ultraviolet B (UVB) therapy, or (vi) systemic anti-inflammatory agents
8) Use within 2 weeks prior to baseline of: (i) topical anti-psoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene, tazarotene, (ii) topical corticosteroids, (iii) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), or (iv) topical retinoids
9) Other prescription and over-the-counter drug products, procedures, and activities that are prohibited during the study, such as a) Topical product other than the assigned treatment (including moisturizers, new
brands of make-up, creams, ointments, lotions, and powders) applied on or near
the treatment area
b) Topical or systemic antipsoriatic treatment (e.g., anthralin, coal tar, tazarotene, retinoids, tacalcitol, infliximab, adalimumab, alefacept, PUVA therapy, UVB therapy)
c) Topical or systemic corticosteroids
d) Immunosuppressive drugs
e) Initiation of or changes to non-antipsoriatic concomitant medication that could affect psoriasis (e.g., beta blockers, lithium) during the study
f) Tanning booths, sun lamps, or nonprescription UV light sources
g) Phototherapy
h) The treated areas should not be bandaged, covered or wrapped as to be occlusive
i) Subjects should be instructed to minimize exposure to natural sunlight, to not allow the ointment to come in contact with the face or eyes and to always wash hands thoroughly after use
10) Concurrent or history of other inflammatory, infectious and immunocompromised diseases
11) Current or chronic history of liver disease, known hepatic or biliary abnormalities
12) Current or a history of cancer within 5 years
13) A history of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator’s opinion, may interfere with the subjects’ participation in the trial and ability to understand and give informed consent.
14) Planned surgery or hospitalization (anticipated to last greater than 72 hours) during the trial.
15) 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.
16) Clinically significant abnormalities in ECG or Screening laboratory parameters
17) Non-cooperation with clinical trial staff.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
On-site computer system
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
To evaluate the efficacy of Tapinarof cream, 1% compared with Vtama Cream and Placebo (vehicle) cream in adults with plaque psoriasis
Proportion of trial participants who achieve a Physician’s Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2-grade improvement from Baseline to Week 12
Secondary Outcome
Outcome
TimePoints
To evaluate the safety and tolerability of Tapinarof cream, 1% compared with Vtama Cream and Placebo (vehicle) cream in adults with plaque psoriasis
i) Mean change in percentage Body Surface Area (BSA) affected from Baseline to Week 12.
ii) Proportion of trial participants with greater than or equal to 75 percentage improvement in PASI score from Baseline to Week 12.
iii) Proportion of trial participants with greater than or equal to 50 percentage improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 12
iv) Proportion of trial participants with greater than or equal to 90 percentage improvement in PASI score from Baseline at Week 12
Total Sample Size="400" Sample Size from India="400" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
19/05/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="3" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
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
Primary objective is to evaluate the efficacy of Tapinarof cream, 1% compared with Vtama Cream and Placebo (vehicle) cream in adults with plaque psoriasis and secondary objective is to evaluate the safety and tolerability of Tapinarof cream, 1% compared with Vtama Cream and Placebo (vehicle) cream in adults with plaque psoriasis.