CTRI/2022/08/045019 [Registered on: 29/08/2022] Trial Registered Prospectively
Last Modified On:
25/01/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A Study will be conducted in Patients with Moderate to Severe Atopic Dermatitis using Tacrolimus 0.03% Topical Ointment
Scientific Title of Study
A Randomized, Double-Blind, Vehicle-Controlled, Three arm, Parallel Group, Multi-Centric, Clinical Study to Establish the Therapeutic Equivalence of Tacrolimus 0.03% Topical Ointment of Intas Pharmaceuticals Limited with Protopic® 0.03% Topical Ointment in Patients with Moderate to Severe Atopic Dermatitis
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
0414-21,Version-1.0, Date 27-Jan-2022
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Prashant Modi
Designation
Sr. 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 382481 India
Phone
07940202375
Fax
07940202021
Email
prashantmodi@lambda-cro.com
Details of Contact Person Scientific Query
Name
Dr Naman Shah
Designation
Sr. 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 382481 India
Phone
07940202389
Fax
07940202021
Email
namanshah@lambda-cro.com
Details of Contact Person Public Query
Name
Prashant Modi
Designation
Sr. 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 382481 India
Phone
07940202375
Fax
07940202021
Email
prashantmodi@lambda-cro.com
Source of Monetary or Material Support
Intas Pharmaceuticals
Limited, India, Corporate House,
Near Sola Bridge, S.G. Highway, Thaltej,
Ahmedabad – 380054, Gujarat, India
Primary Sponsor
Name
Intas Pharmaceuticals Limited India
Address
Corporate House,Near Sola Bridge, S.G. Highway, Thaltej,Ahmedabad – 380054, Gujarat, India.
Department of Clinical Research,Room No.N/A,Amena Khatun Multi-Speciality Hospital, Sarkhej Road, Ahmedabad - 380055. Ahmadabad GUJARAT
990474445
akhresearch2022@gmail.com
Dr Shekhar Pradhan
B.J. Govt. Medical College And Sassoon General Hospital, Pune
Department of Clinical research,Room No.N/A,B.J. Govt. Medical College And Sassoon General Hospital, Pune, Jayprakash Narayan Road, Near Pune Railway Station, Pune - 411001, Maharashtra, India. Pune MAHARASHTRA
9923184181
drshekharp10@gmail.com
Dr Hemant Talanikar
Dr. D.Y.Patil Medical College, Hospital and Research Centre
Department of Clinical Research,Room No.NA,Dr. D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra - 411018. Pune MAHARASHTRA
9422087726
hemant.vasant16@gmail.com
Dr Anuj Kothari
GBH Memorial Cancer Hospital
Department of Clinical Research, Room No. NA, GBH Memorial Cancer Hospital, American International Institute of Medical Sciences, Near Transport Nagar, Airport Rd, Bedwas, Udaipur, Rajasthan - 313002 Udaipur RAJASTHAN
9723289007
dr.anujkotharinm@gmail.com
Dr Dev Prakash Shivhare
GSVM Medical College, Kanpur/LLR Hospital
Department of Clinical research,Room.No/N/A,Department of Dermatologist, GSVM Medical College, Swaroop Nagar, Kanpur - 208002. Jalaun UTTAR PRADESH
9450136374
drdev.derma@gmail.com
Dr Ghanshyam Vinod
Jupiter Hospital and Research Centre
Department of Clinical Research,Room No. NA, Jupiter Hospital & Research Center, Shop 9 GF, Sun Pharma Atladara Road, near Lion Masala Mill, Pramukh Swami nagar, Atladra, Vadodara - 390012, Gujarat Vadodara GUJARAT
9824488194
dr.ghanshyam.vinodnm@gmail.com
Dr BL Nanjundaswamy
K R Hospital MMC & RI Mysuru
Department of Clinical Research,Room No,14, Department of Dermatology, K R Hospital attached to Mysore Medical College and Research Institute, Irwin Road, Mysuru - 570001, Karnataka, India Mysore KARNATAKA
9448025219
drblnswami@gmail.com
Dr Smita Nagpal
Khyati Multispeciality Hospital
Department of Clinical Research, Room No.: 235/2 B/S, Tata Motors Showroom, Opp. Rajpath Club, SG Highway, Bodakdev Ahemdabad -380015, Gujarat India Ahmadabad GUJARAT
9825721525
nagpalsmita@gmail.com
Dr G Ajay Kumar
King George Hospital
Department of Clinical Research,Room No.N/A,Department of Dermatology, King George Hospital, Andhra Medical College, Maharanipeta, Visakhapatnam - 53002. Visakhapatnam ANDHRA PRADESH
8555976042
gireeshbt2007@gmail.com
Dr Patnala Guru Prasad
King George Hospital
Department of Clinical Research Room, Department of Dermatology, King George Hospital, Andhra Medical College, Maharanipeta, Visakhapatnam - 53002 Visakhapatnam ANDHRA PRADESH
9848022615
drpguruprasadresearch@gmail.com
Dr Nandita Patel
Kiran Multyspeciality Hospital
Department of Clinical Research,Room No.N/A,Kiran Hospital Near Sumul Dairy Surat, Gujarat-395004 Surat GUJARAT
9730840004
nandita.patel@kiranhospital.com
Dr Bhavik Bhavsar
Lavanya Skin Clinic & Laser Centre
Department of Clinical Research,Room No.303, Aishwarya Complex, Near Hirabhai Tower, Jawahar Chowk, Maninagar, Ahmedabad, Gujarat - 380008. Ahmadabad GUJARAT
9825953263
bhavikbhavsar78@gmail.com
Dr Anjeeta Dhawan
Maharaja Agrasen Hospital
Department of Clinical research,Room No.N/A,West Punjabi Bagh, New Delhi, Delhi - 110026. New Delhi DELHI
9810631823
anjeetadr@gmail.com
Dr Mahesh Patel
Medistar Multispeciality Hospital
Department of Clinical Research, Room No. NA, Trimurti Avenue, Medistar cross road, NH-8, Himatnagar-3803001, Gujarat, India Sabar Kantha GUJARAT
8128999569
maheshpatel1975@yahoo.com
Dr Dipak Patel
Nirmal Hospital PVT LTD.
Department of Clinical Research, Room No. NA,Ring Road, Surat - 395002, Gujarat, India Surat GUJARAT
9374711540
dr.dipak.patel@gmail.com
Dr Mitesh Thakkar
Patan Janata Hospital
Department of Clinical Research, Room No. NA, Patan Janata Hospital, Sardar Road, Near Railway 1st Under Bridge, Patan - 384265, Gujarat, India Patan GUJARAT
9687170277
miteshthakker1990@gmail.com
Dr Ruchir Shah
Sanjivani Super Speciality Hospital Pvt. Ltd.
Department of Clinical Research,Room No 1-Uday Park Society, Nr Sunrise Park, Vastrapur, Ahmedabad - 380015, Gujarat, India. Ahmadabad GUJARAT
9904079691
drruchirshah.dermatologist@gmail.com
Dr Keyur Shah
Shree Vrajesh Surgical Hospital
Department of Clinical research,Room No.N/A,Shree Vrajesh Surgical Hospital, opp. Rajapath Club, Cargo Motor Lane, S.G. Raod, Bodakdev - Ahmedabad, Gujarat - 380015. Ahmadabad GUJARAT
9879004822
drkeyurshah@yahoo.com
Dr Santoshdev Rathod
Smt. NHL Medical College, Smt. Shardaben Chimanlal Lalbhai-Municipal General Hospital
Department of Clinical Research,Room No.NA, Smt. NHL Medical College, Sayedna Kutbuddin Saheed Marg, Saraspur, Ahmedabad - 380018, Gujarat, India Ahmadabad GUJARAT
9909027448
dr.santoshdev.rathodnm@gmail.com
Dr Rajvee Shah
V.S. General Hospital
Department of Clinical research,room No.N/A,V.S. General Hospital, Ellisbridge, Ahmedabad - 380006, Gujarat, India. Ahmadabad GUJARAT
Dose Formulation-Ointment,Route of
Administration-Topical,Dosage Level-Twice daily for 4 weeks
Intervention
Tacrolimus 0.03% topical ointment
Dose Formulation- Ointment,Route of Administration-Topical, Dosage Level-Twice daily for 4 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
Participants are eligible to be included in the study only if all the following criteria apply:
1 Must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate in the study.2 Man or woman participant must be aged 18 years or older, at the time of signing the informed
consent.3 Participants who are medically stable on the basis of physical examination, medical history,
and vital signs performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant source documents and initialed by the investigator.4 Participants who are medically stable on the basis of clinical laboratory tests performed at
screening. If the results of the serum biochemistry panel, hematology assessments are outside
the normal reference ranges, the participant may be included if the investigator judges the
abnormalities or deviations from normal to be not clinically significant or to be appropriate
and reasonable for the population under study.This determination must be recorded in the participant source documents and initialed by the investigator.5 A diagnosis of atopic dermatitis for at least 3 months (participant may verbally report signs and symptoms of atopic dermatitis with an onset at least 3 months prior to screening visit)6 Clinical diagnosis of moderate to severe atopic dermatitis (AD), as defined by the criteria of Hanifin and Rajka at screening visit• Affected area of AD involvement must be at least 10per cent body surface area (BSA) at baseline visit.7 A validated Investigator Global Assessment (vIGA) of disease severity of at least moderate at baseline visit (vIGA assessment score of 3 or 4).8 Participants must have failed to respond adequately to other topical prescription treatments
for atopic dermatitis, or for whom those treatments are not advisable in the opinion of investigator. (Participant verbal report of failure to other topical prescription treatments for AD can be considered.)9 A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies-
• Is not a woman of childbearing potential (WOCBP)
OR Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of more than 1 percent per year), with low user dependency when used consistently and correctly, during the intervention period and for at least 16 days,after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for a period of 16 days after the last dose of study intervention. The investigator should evaluate the effectiveness and the potential for contraceptive method failure (e.g., noncompliance, recently initiated) of the contraceptive method in relationship to the first dose of study intervention.• A WOCBP must have a negative highly sensitive serum beta-human chorionic
gonadotropin (beta-hCG) test at screening and urine beta-hCG test at baseline.•If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.10 Male participants are eligible to participate if they agree to the following during the intervention period and for at least 16 days after the last dose of study intervention:•Must agree not to donate sperm for the purpose of reproduction.PLUS EITHER•Be abstinent from heterosexual or homosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.OR•Must agree to use contraception /barrier as detailed below− a male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person − male participants should also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.11 Willing and able to adhere to the lifestyle restrictions specified in this protocol.
ExclusionCriteria
Details
1 Documented medical history of clinically significant cardiac, vascular, pulmonary,
gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or
metabolic disturbances or any other medical condition(s) for which, in the opinion of the
investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specifiedassessments.
2 Known allergies, hypersensitivity, or
intolerance to tacrolimus topical ointment or its
excipients (refer to the product monograph of Protopic®)
3 Contraindications to the use of tacrolimus 0.03% topical ointment per product monograph of
Protopic®.
4 Has documented medical history or current evidence of positive hepatitis B surface
antigen (HBsAg) at screening.
• Has documented medical history or current evidence of positive hepatitis C antibody at
screening.
5 Has documented medical history or current evidence of human immunodeficiency virus
(HIV) infection at Screening.
6 Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years; carcinoma in situ of the cervix; or malignancy, which is considered cured with minimal risk of recurrence.
7 Clinically significant severe renal insufficiency or severe hepatic disorders as judged by the investigator.
8 Active cutaneous bacterial or viral infection in any treatment area at baseline (e.g., clinically
infected atopic dermatitis as judged by the investigator) requiring oral antimicrobials within
14 days prior to baseline and topical antimicrobials within 7 days prior to baseline.
9 Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at baseline, which
would interfere with evaluations in the opinion of the investigator.
10 History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or ichthyosis
in the areas affected by atopic dermatitis or who are judged inappropriate for assessment of
AD in the present study as per investigator’s discretion.
11 Participant with a known case of genetic epidermal barrier defect such as Netherton’s
syndrome.
12 History or known case of congenital or acquired immunodeficiencies, which in the
investigator’s opinion would contraindicate the use of immunosuppressants.
13 Presence of serious active infection (use of IV antimicrobials or invasive procedures required
for treatment), or recurrent infection as judged by the investigator, within last 14 days from
baseline
Method of Generating Random Sequence
Stratified randomization
Method of Concealment
An Open list of random numbers
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
-To establish the therapeutic equivalence between tacrolimus-test and tacrolimus-reference in participants with moderate to severe atopic dermatitis.-To establish superiority of tacrolimus-test and tacrolimus-reference over vehicle in participants with moderate to severe atopic dermatitis
-Proportion of participants with treatment success based on validated Investigator Global
Assessment scale for Atopic Dermatitis at the end of treatment (Day 29).− Treatment success is defined as a grade of clear or almost clear; a score of 0 or 1, within all treatment areas
Secondary Outcome
Outcome
TimePoints
To evaluate the efficacy of tacrolimus-test,tacrolimus-reference and vehicle in participants with moderate to severe atopic dermatitis
• Mean change from baseline to end of treatment(Day 29) in severity of four individual signs and symptoms of AD (i.e., erythema,induration/papulation, lichenification and pruritus)
Target Sample Size
Total Sample Size="354" Sample Size from India="354" 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)
01/09/2022
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="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
None
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, Vehicle-Controlled, Three arm, Parallel Group, Multi-Centric, Clinical Study to Establish the Therapeutic Equivalence of Tacrolimus 0.03% Topical Ointment of Intas Pharmaceuticals Limited with Protopic® 0.03% Topical Ointment in Patients with Moderate to Severe Atopic Dermatitis