clinical Study of Pimecrolimus cream in Atopic dermatitis patients in India
Scientific Title of Study
A Randomized, Double Blind, Placebo Controlled, Three arm, Parallel, Multicentre, Study to Evaluate the Bioequivalence using Clinical Endpoint of Pimecrolimus Cream, 1% of Encube Ethicals Private Limited, India to Pimecrolimus Cream, 1% of Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA in Treatment of Mild to Moderate Atopic Dermatitis.
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
G7SYN/P-007/2023; Amendment version 01 date 11/12/23
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Dr D Sathish Kumar
Designation
Managing Director
Affiliation
G7 Synergon Private Limited
Address
Managing director room/first floor, contract Research Oraganization,
No 537 9th Cross 5th main Tata Nagar Sahakaranagar Post
Bangalore Karnataka Bangalore KARNATAKA 560092 India
Phone
9677014651
Fax
Email
sathishkumar@g7synergon.in
Details of Contact Person Scientific Query
Name
Dr D Sathish Kumar
Designation
Managing Director
Affiliation
G7 Synergon Private Limited
Address
Managing director room/first floor, contract Research Oraganization, No 537 9th Cross 5th main Tata Nagar Sahakaranagar Post Bangalore Karnataka India
Bangalore KARNATAKA 560092 India
Phone
9677014651
Fax
Email
sathishkumar@g7synergon.in
Details of Contact Person Public Query
Name
Dr D Sathish Kumar
Designation
Managing Director
Affiliation
G7 Synergon Private Limited
Address
Managing director room/first floor, contract Research Oraganization, No 537 9th Cross 5th main Tata Nagar Sahakaranagar Post Bangalore Karnataka India
Bangalore KARNATAKA 560092 India
Phone
9677014651
Fax
Email
sathishkumar@g7synergon.in
Source of Monetary or Material Support
Encube Ethicals Private Limited Unit No. 24, Steelmade Industrial Estate, Marol Village, Andheri (E), Mumbai – 400 059
Primary Sponsor
Name
Encube Ethicals Private Limited
Address
Encube Ethicals Private Limited
Unit No. 24, Steelmade Industrial Estate,
Marol Village,
Andheri (E),
Mumbai – 400 059
Atharv Multispecialty Hospital and Research Centre
OPD no 2, Ground floor, H-4/Comm-2, Construction Div-21, UP Avas Vikas Parishad, Sector- E, Lucknow-226003, Uttar Pradesh, India. Lucknow UTTAR PRADESH
9005044010
dermavipul@gmail.com
Dr Pawan Singh
Atmaram Child Care and Critical Care Hospital
Atmaram Child Care and Critical Care Hospital, Department of Dermatology, Ground Floor, Room No- 01, of 53/128 Y Block Naubasta Kanpur Dehat UTTAR PRADESH
9026373593
drpawanderma2020@gmai.com
Dr Nisha Tushar Parikh
CIMETs Inamdar Multispeciality Hospital
OPD no. 02, Ground floor, Hospital building, Department of dermatology, CIMETs Inamdar Multispeciality Hospital, S.No. 15, Fathima Nagar, Wanawadi, Pune - 411040, Pune MAHARASHTRA
9673834553
drnishaparikh@gmail.com
Dr Wani Imran Majid
Cutis Institute of Dermatology
Cutis Institute of Dermatology, Dermatology OPD, Ground Floor, Room No : 01, Hyderpora, Srinagar, Jammu and Kashmir-190014, India. Jammu JAMMU & KASHMIR
7006971891
drimranmajid@gmail.com
Dr Dev Prakash Shivhare
GSVM Medical College
OPD Room No. 11, Department of Dermatology, Ground floor, GSVM Medical College Swaroop Nagar, 208002 India Kanpur Kanpur Nagar UTTAR PRADESH
9450136374
devprakash.80@gmail.com
Dr Vaz Geoffrey Floyd
HBT Trauma care Hospital
OPD No. 106, First floor, Department of dermatology, HBT Trauma care Hospital, Ajgaokar plot, Western Express Highway, Jogeshwari east, Mumbai 400060 Mumbai MAHARASHTRA
8976101326
drgeoffreyvaz1@yahoo.com
Dr Richa Gupta
Health 1 Superspeciality Hospital
Health 1 Superspeciality Hospital, Departmant of Dermatology, 1st Floor, Room No. 05, Shalaj Circle, Sardar Patel Ring Road, Near Venetian Villa, Thaltej, Ahmedabad, Gujarat-380059, India.
Ahmadabad GUJARAT
9879245064
drricha08.gupta@gmail.com
Dr Patnala Guru Prasad
King George Hospital
1st Floor, Clinical Research Area, Department of Dermatology, King George Hospital, Andhra Medical College, Maharanipeta, Visakhapatnam-530002, Andhra Pradesh, India. Visakhapatnam ANDHRA PRADESH
8555976024
drpguruprasadresearch@gmail.com
Dr Bangaru H
KR Hospital
KR Hospital, Attached to Mysore Medical College and research institute,Dermatology OPD, 1st Floor, Room No- 14, Irwin Road - 570001, Mysuru, Karnataka, India. Mysore KARNATAKA
9886789231
drbangaruskin@gmail.com
Dr Balkrishna Pralhadrao Nikam
Krishna Vishwa Vidyapeeth University
Krishna Vishwa Vidyapeeth University, Department of Dermatology, Room No-29, Pune-Bangalore Highway, Agashivnagar, Malkapur, Karad, Maharashtra -415539 Satara MAHARASHTRA
8275061393
nitaldermpath@gmail.com
Dr Aparna Vijay Gaikwad
Medinova Shatabdi Hospital
Medinova Shatabdi Super Speciality Hospital, Dermatology OPD, 1st Floor, Room No: 02, Suyojit city centre opp.mahamarg bus stand, mumbai naka,nashik, Maharastra- 422005, India Nashik MAHARASHTRA
9881269249
draparnagaikwad12@gmail.com
Dr Grandhi Sudhakarrao Venkata
Medipoint Hospitals Pvt.
Medipoint Hospitals Pvt. Ltd., Department of Dermatology, Room No-01, , OPD Bulding, 241/1, New D. P. Road, Aundh, Pune-411007 Pune MAHARASHTRA
Oyster and Pearl Hospital (Phadnis Clinic Pvt Ltd)
Oyster and Pearl Hospital (Phadnis Clinic Pvt Ltd), Dermatology OPD, 5th Floor,Room No-504, Ganeshkhind Road, Shivajinagar, Pune-411005 Pune MAHARASHTRA
9822879476
drajaydespande1997@gmail.com
Dr Makwana Dhwaniben Ranchhodbhai
Parth Hospital
Parth Hospital, E/405-4, Deparment of Dermatology, 4th Floor Galaxy Arcade, Room No:407-411, Near Galaxy Cinema, Naroda, Ahmedabad- 382330 Ahmadabad GUJARAT
9662133253
dhwanimakwanacr722@gmail.com
DrPatel Dharaben Dhanjibhai
PHC- Prajna Health Care
PHC- Prajna Health Care, Dermatology OPD, Consulting Room- 205-208, 2nd floor, Aagam avenue, Near adani CNG pump, Sabarmati, Ahmedabad-380005 Ahmadabad GUJARAT
9427318224
ddpatel.1411@gmail.com
Dr Sonal Arvind Chavan
Sangvi Multispeciality Hospital Pvt Ltd
Sangvi Multispeciality Hospital Pvt Ltd, Dermatology OPD, Room No-03, Sr No 71/1/2/189, City Survey No 2387, Krushna Chowk, Krushna Nagar, New Sangvi, Pune-411027 Pune MAHARASHTRA
9960666158
drsonalc786@gmail.com
Dr Adarsh Gowda
Santhosh Hospital
Santhosh Hospital, Department of Dermatology, Ground Floor, Room No-11, 6/1 Promenode road,behind coles park Bangalore-560005 Bangalore KARNATAKA
Shree Giriraj Multispeciality Hospital, Department of Dermatology, OPD No- 4, A Unit of Shree Giriraj Lifecare Pvt. Ltd., 27-Navjyot Park Corner, 150 Feet Ring Road, Rajkot-360005 Rajkot GUJARAT
Shri Guru Ram Rai Institute of Medical & Health Science, Shri Mahant Indiresh Hospital, Dermatology OPD, Ground Floor, Room No: 02 Patel Nagar, Dehradun,Uttarkhand--248001, India Dehradun UTTARANCHAL
9675365144
neetithakur07@gmail.com
Dr Milap Jolapara
Shubham Multispeciality Hospital
Shubham Multispeciality Hospital, Departmant of Dermatology, Ground Floor, ABC Complex, Rabari Colony Char Rasta, N. H. No. 8, Amraiwadi, Ahmedabad-380026, Gujarat, India. Ahmadabad GUJARAT
Placebo: Placebo (vehicle) of Pimecrolimus Cream, 1% of Encube Ethicals Private Limited, India.
A thin layer of Investigational Product shall be applied only to the affected skin areas, two times each day (Morning and Evening) for 2 weeks (14 days).
Comparator Agent
Reference Product: Pimecrolimus Cream, 1% of Oceanside Pharmaceuticals a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA.
A thin layer of Investigational Product shall be applied only to the affected skin areas, two times each day (Morning and Evening) for 2 weeks (14 days).
Intervention
Test Product: Pimecrolimus Cream, 1% of Encube Ethicals Private Limited, India.
A thin layer of Investigational Product shall be applied only to the affected skin areas, two times each day (Morning and Evening) for 2 weeks (14 days).
Inclusion Criteria
Age From
12.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Non-immuno compromised male or non-pregnant, non-lactating female aged 12 years and older with a clinical diagnosis of mild to moderate atopic dermatitis.
2. Subject with clinical diagnosis of mild to moderate atopic dermatitis that has failed to respond adequately to other topical prescription treatments for atopic dermatitis, or for whom those treatments are not advisable as per the Investigator.
3. Subject has confirmed diagnosis of atopic dermatitis for at least 3 months.
4. Subjects having an Investigator’s Global Assessment (IGA) of disease severity of mild or moderate at baseline. (a score of 2 (mild) or 3 (moderate)).
5. Subject having an affected area of atopic dermatitis involvement of at least 5 Percentage Body Surface Area (BSA) at baseline, as defined by the criteria of Hanifin and Rajka criteria.
6. Female subject must have a negative Urine Pregnancy Test at the time of screening or Female Subject of non-child bearing potential.
7. Female Subject of childbearing potential practicing an approved method of contraception that is stable at least 3 months prior to baseline and throughout the study. Acceptable forms of birth control include any of the following: (1) hormonal birth control, which must be stable for more than 3 months prior to baseline; (2) abstinence; subject must use condom plus spermicide if becomes sexually active; (3) double barrier method, such as condom plus spermicide.
8. Male Subject must use accepted methods of birth control or must agree to practice abstinence from study entry until the application of Investigational Product.
9. Willing to provide written informed consent or assent, as applicable. For Subjects who are considered minors (less than 18 completed years), the parent or legal guardian shall sign the consent form and the child shall be required to sign a Subject assent form, as appropriate.
ExclusionCriteria
Details
1. Females who are pregnant, breastfeeding, or who wish to become pregnant during the study period.
2. Active cutaneous bacterial or viral infection in any treatment area at baseline (e.g., clinically infected atopic dermatitis, impetigo).
3. Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline, which would interfere with evaluations.
4. History or presence of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, ichthyosis, or scabies.
5. History or presence of Netherton’s Syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders.
6. Concurrent disease or treatment likely to interfere with the study treatment or evaluations.
7. Use within one month prior to baseline of i) Oral or intravenous corticosteroids, ii) UVA/UVB therapy, iii) PUVA (psoralen plus ultraviolet A) therapy, iv) Tanning booths, v) Nonprescription UV light sources, vi) Immunomodulators or immunosuppressive therapies, vii) Interferon, viii) Cytotoxic drugs, ix) Tacrolimus and x) Pimecrolimus.
8. Use within 14 days of baseline of i) Systemic antibiotics, ii) Calcipotriene or other vitamin D preparations, iii) Retinoids.
9. Use within 7 days prior to baseline of i) Systemic antihistamines, ii) Topical antibiotics, iii) Topical corticosteroids, and iv) other topical drug products.
10. Use within 24 hours prior to baseline of any topical product (e.g., sunscreens, lotions, creams bland emollient/moisturizer) in the areas to be treated.
11. Known allergy or hypersensitivity to pimecrolimus or any other component of the test product or reference product
12. Not willing to minimize or avoid natural and artificial sunlight exposure during treatment
13. Subject with clinically significant vital sign abnormality.
14. Subject with clinically significant unstable medical disorders, life-threatening disease.
15. Subject who has been treated with an investigational drug or investigational device within a period of 30 days prior to study enrolment.
16. Subject who are directly employed at the study site and are associated with conduct of this study.
17. Living in the same household of a subject who is currently participating in this study or living in the same household of a subject who has previously participated in this study.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
The proportion of subjects in each treatment group with treatment success based on the Investigator’s Global Assessment of Disease Severity
Clinical Success is defined as an IGA score of 0 or 1, within the treatment area.
Clinical Failure is defined as an IGA score of more than 1.
Baseline to Day 15
Secondary Outcome
Outcome
TimePoints
Change in severity of four individual signs and symptoms of AD (i.e., erythema, induration/papulation, lichenification, and pruritus).
Baseline to Day 15
Target Sample Size
Total Sample Size="690" Sample Size from India="690" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Its
a Randomized, Double-Blind, Placebo-Controlled, three arms Parallel-Design,
Multiple-Site Study to Evaluate the Therapeutic Equivalence and Safety of
Pimecrolimus Cream, 1% (Encube Ethicals Private Limited) with Pimecrolimus
Cream, 1% of Oceanside Pharmaceuticals, a division of Bausch Health US, LLC
Bridgewater, NJ 08807 USA in the Treatment of Mild to Moderate Atopic
Dermatitis.
The
study will recruit 690 patients only from India.
Patients
meeting the eligibility criteria will be randomized in 1:1 ratio to the
treatment arms.
Subjects
shall complete four scheduled clinic visits as follows:
·Visit 1#: Screening Visit (Up to 2 days
prior to Randomization)
·Visit 2#: Baseline/RandomizationVisit (Day 0)
·Visit 3 : Interim Visit, on Day 8 (± 2 days)
·Visit 4 : EndofTreatmentVisit* on Day 15 (+ 2 days)
End of Study/Safety follow-up: 7 days (± 2 days) after end
of the last application of Investigational Product. The total duration of the
study is 11 Months.