| CTRI Number |
CTRI/2023/02/049923 [Registered on: 21/02/2023] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The study to evaluate the effectiveness and safety of Elidel® in small children/babies affected by mild to moderate Atopic dermatitis (AD) in India |
|
Scientific Title of Study
|
An observational study to evaluate the effectiveness and safety of Elidel® in infants and children affected by mild to moderate Atopic dermatitis (AD) in India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MyMAAP PACRS 2020-003, Version 1.0 dated 20 Sep 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kiran Godse |
| Designation |
Dermatologist |
| Affiliation |
Shree skin center |
| Address |
1st floor, Department of dermatologist, PI associated with Shree skin center, L- Market, Mata Amritanandamayi Marg, Sector 8, near MGM SCHOOL, Nerul West, Navi Mumbai, Maharashtra 400706
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9322266687 |
| Fax |
|
| Email |
drgodse@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Pai MD |
| Designation |
Emerging Markets Medical Lead - Dermatology Specialty Excellence |
| Affiliation |
Mylan Pharmaceuticals Private Limited |
| Address |
Mylan Pharmaceuticals Private Limited, 11th Floor, Prestige Platina,
Block 3, Kadubeesanahalli Village,
Varthur Hobli, Outer Ring Road
Bangalore 560 087, India
Bangalore
KARNATAKA
560087
India |
| Phone |
8066728332 |
| Fax |
|
| Email |
sunil.pai@viatris.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Suresh Nachankar |
| Designation |
Senior General Manager |
| Affiliation |
Mylan Pharmaceuticals Private Limited |
| Address |
Mylan Pharmaceuticals Private Limited, 9th Floor, Prestige Platina Tech Park,
Block 3, Kadubeesanahalli, Outer Ring Road,
Bangalore – 560103.
Bangalore
KARNATAKA
560103
India |
| Phone |
9148448205 |
| Fax |
|
| Email |
Rajesh.Nachankar@viatris.com |
|
|
Source of Monetary or Material Support
|
| Mylan Pharmaceuticals Private Limited
situated at 10th floor, Prestige Platina Technology Park, Block No-3, Kadubesanahalli,
Varthur Hobli, Outer Ring Road, Bengaluru-560 103 |
|
|
Primary Sponsor
|
| Name |
Mylan Pharmaceuticals Private Limited |
| Address |
situated at 10th floor, Prestige Platina Technology Park, Block No-3, Kadubesanahalli, Varthur Hobli, Outer Ring Road, Bengaluru-560 103 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Urvi Panchal |
Aarvy Hospital |
Room No 515, Department of dermatology, Sector 90, Gurgaon, Haryana,122505
Gurgaon
HARYANA |
8800827110
drurvi77@gmail.com |
| Dr Sowmya Naga Dogiparthi |
Apollo Children Hospital |
(A unit of Apollo Hospital Enterprises Ltd with registered office at 19, Bishop Gardens, Raja Anna Malaipuram, Chennai -600028), Located at No. 15, Shafi Mohammed Roa Thousand Lights, Chennai-600006, Tamil Nadu, India
Chennai
TAMIL NADU |
9840753698
sowmy88688@gmail.com |
| Dr Shireen Furtado |
Ayana Clinic |
ground floor 13A cross, 278 , 15th main road behind SBI bank sahakar nagar Bangalore, Karnataka, India
Bangalore
KARNATAKA |
9108051982
shireenseq@gmail.com |
| Dr Eswari L |
Dr. Eswari L |
Jayanagar 4 block, Banglore 60,62, 8th Main Road, Near Nandini Hotel, Near Temple Silks, Bangalore
Bangalore
KARNATAKA |
9845935375
eshwaril@yahoo.com |
| Dr Mitul Patel |
Navneet Memorial Hospital "SUSHRUSHA |
Opp. Sardar Patel Seva Samaj Hall, In the Lane, Opp. Tele. Exchange, Navrangpura, Ahmedabad - 380009
Ahmadabad
GUJARAT |
9558025435
drmitulpatelcr@gmail.com |
| Dr Vijay Kumar Sonkar |
S.N medical college, Agra |
Department of Dermatology, Section 2, Central Library, Moti Katra, Mantola, Agra, Uttar Pradesh 282003
Agra
UTTAR PRADESH |
9412561550
researchsnmc111@gmail.com |
| Dr Abhishek R Shetty |
Shetty’s Skin and Hair Clinic |
Ramanagara, Bangalore, Karnataka, India- 562159
Bangalore
KARNATAKA |
9886335354
shetty.abhi18@gmail.com |
| Dr Kiran Godse |
Shree skin center |
1st floor, Department of dermatologist,L- Market, Mata Amritanandamayi Marg, Sector 8, near MGM SCHOOL, Nerul West, Navi Mumbai, Maharashtra 400706
Mumbai (Suburban)
MAHARASHTRA |
9322266687
drgodse@gmail.com |
| Dr Shobhita Gupta |
Silver Streak Multi Speciality Hospital |
Room No 001, Department of dermatology, Sector 87, Gurugram, Haryana 122505
Gurgaon
HARYANA |
9720006071
dermatologist@silverstreakhospital.com |
| Dr Venkataram Mysore |
Venkat Charmalaya Centre |
Venkat Charmalaya Centre for Advanced Dermatology and Postgraduate Training, Vijaynagar Bangalore 560040
Bangalore
KARNATAKA |
9845363520
mnvenkataram@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 13 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
| ACE Independent Ethics Committee |
Approved |
| ACE Independent Ethics Committee |
Approved |
| ACE Independent Ethics Committee |
Approved |
| ACE Independent Ethics Committee |
Approved |
| Institutional Ethics Commitee |
Approved |
| Institutional Ethics Committee New healthcare Nursing Home |
Approved |
| Institutional Ethics Committee S N Medical Collegeee |
Approved |
| Ripon Independent Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
| Sangini Hospital Ethics Committee |
Approved |
| Society for research welfare Ethics committee |
Approved |
| Society for research welfare Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1. Signed informed consent from patients’ parent(s) or legal guardian(s) in compliance with local regulation
2. Patients of Indian ethnicity
3. Male and female infants and children who are at least 3 months to a maximum of 5 years of age at baseline (V1)
4. Diagnosis of mild to moderate Atopic dermatitis (SCORAD index <50)
5. Prescribed Elidel® 1% w/w for mild to moderate AD as part of routine clinical care and in accordance with product label prior to inclusion |
|
| ExclusionCriteria |
| Details |
1. Patients for whom Elidel® is not recommended according to the Package Insert
2. Patients with severe AD (SCORAD ≥50)
3. Active viral infections at the treatment site
4. Receiving systemic glucocorticoids, antibiotics, antifungals, immunomodulators, antihistamines and ultraviolet radiation therapy within the last 4 weeks before inclusion
5. Receiving any topical AD-effective drugs within the last 2 weeks before inclusion
6. Known or suspected hypersensitivity to pimecrolimus or any component of the cream
7. Patients parent(s)/legal guardian (as applicable) that are not able to fulfill study requirements according to physician’s opinion
8. Patients parent(s) / legal guardian (as applicable) who refuse to participate in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the SCORing Atopic Dermatitis (SCORAD) index reduction in the AD areas from inclusion to the end of Elidel® treatment period. |
Each Visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Treatment duration with Elidel®
2. Number of visits during Elidel® treatment period and during the maintenance phase
3. Reduction of symptoms based on the Visual analogue scale in the SCORAD index during Elidel® treatment period
4. Number of days and kind of AD treatments during maintenance phase
5. Number of days lost from school and/or work for patients and/or caregivers, due to AD assessed at each visit
6. Quality of life assessed by validated questionnaires at inclusion (V1), at Elidel® treatment interruption (V2) and at End of Study Visit (EoS) (V3), considering the last seven days before the assessment. Questionnaire will be selected based on patients’ age:
a. The Infants’ Dermatitis Quality of Life Index (IDQOL) (below the age of 4 years)
b. Children’s Dermatology Life Quality Index (CDLQI) (from the age of ≥4 to ≤5 years)
7. Elidel® safety and tolerability |
1. Treatment duration with Elidel® in days from V1 to V2.
2. Number of physical as well as telephonic visits made during V1 to V2 and V2 to V3
3. Each visit
4. At the interruption visit (V2), the type of AD treatment prescribed, and number of days will be recorded up to V3 which will be at least 45 days±10 days from V2.
5. Each visit
6. (V1), at Elidel® treatment interruption (V2) and at EoS (V3), considering the last seven days before the assessment.
7. Each visit except V1 |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "130"
Final Enrollment numbers achieved (India)="130" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/02/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This Phase-IV, prospective, multicenter, open-label, single arm, observational study is planned to be conducted in India. Physicians participating will be those usually involved in the management of mild to moderate AD. Approximately 9-10 centers across India will be involved and a total of approximately 130 patients with mild to moderate AD (SCORAD index <50, SCORAD is a clinical tool used to assess the extent and severity of eczema) aged at least 3 months up to a maximum of 5 years are planned to enroll in this study. This decision to prescribe Elidel must be prior and independent from the decision include patients in the study. the patients parents and/or their legal guardians agreement to participate in the study will be obtained by means of signing the informal consent. data to be collected during visit1 (V1)/baseline visit are information on inclusion, patients background (demography, history of AD, symptoms and previous treatments of mild to moderate AD). The physician will record the collected and required information in an electronic case report form (eCRF). assessment of effectiveness, the intended duration of observation per patient is approximately 3 months, allowing certain flexibility as to respond to usual clinical practice. each patients is intended to follow-up to period of approximately 3 months from V1/baseline. since this is an observational study, patient visits after study entry (inclusion) should be performed as per the physicians discretion and in line with local regulations and standards of clinical practice for the management of AD patients. all the visits should be documented in the eCRF. |