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CTRI Number  CTRI/2023/03/050333 [Registered on: 03/03/2023] Trial Registered Prospectively
Last Modified On: 24/05/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Elovera AD emollient]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative, multicenter, prospective, randomized study to evaluate efficacy, safety and prevention of relapse with Elovera AD emollient vs plain emollient in mild to moderate atopic dermatitis 
Scientific Title of Study   A comparative, multicenter, prospective, randomized study to evaluate efficacy, safety and prevention of relapse with Elovera AD emollient vs plain emollient in mild to moderate atopic dermatitis  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IIS/2022/05 Version 1.0, Dated 16 Dec 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Saswati Halder 
Designation  Professor And HOD 
Affiliation  Calcutta School of Tropical Medicine 
Address  Calcutta School of Tropical Medicine 108, Chittaranjan Avenue, College Square, Kolkata-700073, West Bengal, India

Kolkata
WEST BENGAL
700073
India 
Phone  9434427717  
Fax    
Email  saswatihalder32@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Swapan Biswas 
Designation  Director-Startup And Regulatory Affairs 
Affiliation  Infoclin LLP 
Address  2nd Floor, Flat C1 South East Side, 27 Jodhpur Colony, P.O -Lake Gardens, Kolkata - 700045, WB, India

South Twentyfour Parganas
WEST BENGAL
700045
India 
Phone    
Fax    
Email  swapan@infoclinconsultancy.com  
 
Details of Contact Person
Public Query  
Name  Mr Swapan Biswas 
Designation  Director-Startup And Regulatory Affairs 
Affiliation  Infoclin LLP 
Address  2nd Floor, Flat C1 South East Side, 27 Jodhpur Colony, P.O -Lake Gardens, Kolkata - 700045, WB, India

South Twentyfour Parganas
WEST BENGAL
700045
India 
Phone    
Fax    
Email  swapan@infoclinconsultancy.com  
 
Source of Monetary or Material Support  
Glenmark Pharmaceuticals Limited 
 
Primary Sponsor  
Name  Glenmark Pharmaceuticals Limited 
Address  Glenmark Pharmaceuticals Limited, B/2, Mahalaxmi Chambers, 22, Bhulabhai Desai Road, Mumbai – 400 026. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Saswati Halder  Calcutta School of Tropical Medicine  Calcutta School of Tropical Medicine 108, Chittaranjan Avenue, College Square, Kolkata-700073, West Bengal, India
Kolkata
WEST BENGAL 		 9434427717

saswatihalder32@gmail.com 
Dr Abhishek De  Wizderm Specialty Skin and Hair Clinic  Wizderm Specialty Skin and Hair Clinic Ist floor, Onex Square, 75, Shakespeare Sarani Rd Kolkata- 700017, West Bengal, India
Kolkata
WEST BENGAL 		 9903275551

dr_abhishek_de@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Clinical Research Ethics Committee (CREC-STM), Calcutta School of Tropical Medicine  Approved 
Institutional Ethics Committee For Ajanta Hospital & IVF Centre, Lucknow  Approved 
Institutional Ethics Committee HP Poddar Memorial clinic And Nursing Home  Approved 
Institutional Ethics Committee King George Hospital, Visakhapatnam  Approved 
Institutional Ethics Committee Narayana Medical College And Hospital Nellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L209||Atopic dermatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Desonide cream 0.05% and non postbiotic and non-ceramide based moisturizer   Subjects will receive topical corticosteroid (desonide cream 0.05%) and non postbiotic and non-ceramide based moisturizer twice daily for 4 weeks. 
Intervention  Elovera AD emollient  Subject will receive topical corticosteroid (desonide cream 0.05%) and Elovera AD emollient twice daily for 4 weeks.  
 
Inclusion Criteria  
Age From  3.00 Month(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients from 3 months-75 yrs. of age.
2. Patients who suffer from mild to moderate AD (IGA score of 2-3)
3. Patients willing to provide informed consent/parental consent/assent. 
 
ExclusionCriteria 
Details  1. Patients not deemed fit to be prescribed topical steroids
2. Patients not deemed to be fit to be prescribed emollients
3. Patients unwilling to give informed consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Percentage of patients who achieved resolution in 4 weeks IGA score of clear or almost
clear and ≥2-point reduction from baseline.
2. Percentage of patients who suffered from relapse (Relapse is defined as recurrence of either of AD symptoms like erythema, edema, excoriation and lichenification except itching). 		 Weekly, Day0, Day14(±2), Day28(±2),
Every 2 weeks (telephonic) till 3 months or as and
when patient experiences relapse
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Time to resolution
2. Time to relapse
3. Percentage of patients with eczema free after 3 months
4. Percentage of patients achieving EASI clear or almost clear at end of 4 weeks
5. EASI score at baseline, 2 and 4 weeks
6. VAS for itching at baseline, 2 and 4 weeks
7. DLQI score at baseline and 4 weeks
 		 At Baseline, 2 weeks and 4 weeks, Every 2 weeks till 3 months or as and when patient experiences relapse.  
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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 4 
Date of First Enrollment (India)   10/03/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Atopic dermatitis (AD) is a common, chronic skin disorder that can significantly impact the quality of life of affected individuals as well as their families. It is currently estimated that 10–20% of children and 1–3% of adults in developed countries are affected by the disorder.
According to multiple guidelines including consensus by Indian experts, AAD guidelines and EADV guidelines and irrespective of grade of AD, moisturizers or emollients are crucial to the first line management and maintenance of atopic dermatitis. 
Hence, we decided to conduct a study to evaluate the efficacy, safety and prevention of relapse with Elovera AD emollient vs plain emollient in mild to moderate atopic dermatitis (AD).
 
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