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CTRI Number  CTRI/2018/03/012300 [Registered on: 05/03/2018] Trial Registered Prospectively
Last Modified On: 26/04/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Comparison of desoximetasone and mometasone cream in patients of eczema 
Scientific Title of Study   Assessment of Safety and Effectiveness of Desoximetasone Emollient Cream 0.25% in Comparison to Mometasone Cream 0.1% in Patients with Eczema: MCOR Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Koushik Lahiri 
Designation  Consulting dermatologist and dermatosurgeon 
Affiliation  WIZDERM Speciality Skin and Hair Clinic 
Address  Mani Square, IT-7A, 7th Floor, 164/1 Manicktala Main Road

Kolkata
WEST BENGAL
700054
India 
Phone  9830036112  
Fax    
Email  doctorlahiri@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Anirudha Potey 
Designation  Deputy Manager 
Affiliation  Emcure Pharmaceuticals Ltd 
Address  Survey No. 255/2, Rajiv Gandhi IT Park, MIDC, Hinjwadi, Pune, Maharashtra, India

Pune
MAHARASHTRA
411057
India 
Phone  9769148333  
Fax    
Email  Anirudha.Potey@emcure.co.in  
 
Details of Contact Person
Public Query
 
Name  Anirudha Potey 
Designation  Deputy Manager 
Affiliation  Emcure Pharmaceuticals Ltd 
Address  Survey No. 255/2, Rajiv Gandhi IT Park, MIDC, Hinjwadi, Pune, Maharashtra, India

Pune
MAHARASHTRA
411057
India 
Phone  9769148333  
Fax    
Email  Anirudha.Potey@emcure.co.in  
 
Source of Monetary or Material Support  
Emcure Pharmaceuticals Ltd Survey No. 255/2, Rajiv Gandhi IT Park, MIDC, Hinjwadi, Pune - 411 057, Maharashtra, India  
 
Primary Sponsor  
Name  Emcure Pharmaceuticals Ltd 
Address  Survey No. 255/2, Rajiv Gandhi IT Park, MIDC, Hinjwadi, Pune - 411 057, Maharashtra,India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shyamanta Barua  Assam Medical College  Department of Dermatology, Assam Medical College, Dibrugarh, Assam – 786002
Dibrugarh
ASSAM 
9435546944

drshyamanta@gmail.com 
Dr Ramesh Babu  Citizen skin clinic  No.55, 6th cross, Near Sampige road, Malleshwaram, Bangalore - 560003
Bangalore
KARNATAKA 
9448051840

drrameshbabubv@gmail.com 
Dr Sushil Tahiliani  Dr Sushil Tahilainis Skin and Cosmetology centre  104/105, SV road, Arun Bazar, Opp. Natraj market, Malad West, Mumbai -400064.
Mumbai (Suburban)
MAHARASHTRA 
9820492415

drsushiltt@gmail.com 
Dr Arun Inamdar  Dr. Inamadar clinic  Chalukya nagar west, Solapur road, Bijapur – 586101
Bijapur
KARNATAKA 
9448102920

aruninamadar@gmail.com 
Dr Pradyumna Vaidya  Dr. Vaidya Skin and Laser Treatment Clinic  Bendre Niwas, 1330, Krantiveer Vasudev Phadke Path, Sadashiv Peth, Pune, Maharashtra 411030
Pune
MAHARASHTRA 
9822400964

drpvaidya@gmail.com 
Dr Abir Saraswat  Indushree Skin Clinic  Near Bhutnath Market, Faizabad Road, Lucknow
Lucknow
UTTAR PRADESH 
9415256229

abirsaraswat@yahoo.com 
Dr Ravi Vadrevu  Sai Sudha Hospital  D.No: 21-1-24, Jawahar Street, Salipeta, Kakinada
East Godavari
ANDHRA PRADESH 
9848160147

ravi58v@yahoo.com 
Dr Kiran Godse  Shree skin centre & pathology lab  office no 21/22, L Market, 1st floor, 22 L market Sector 8 Nerul, Navi Mumbai – 400706
Mumbai
MAHARASHTRA 
9322266687

drgodse@gmail.com 
Dr Koushik Lahiri  WIZDERM Speciality Skin and Hair Clinic  Mani Square, IT-7A, 7th Floor, 164/1 Manicktala Main Road, Kolkata – 700054
Kolkata
WEST BENGAL 
9830036112

doctorlahiri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Independent Ethics Committee Dhanashree Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Eczema,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Desoximetasone  0.25% emollient cream 
Comparator Agent  Mometasone  0.1% cream 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Who are capable of complying with protocol
requirements
2. Newly diagnosed, treatment-naïve patients with clinical diagnosis of eczema
3. Patients treated with desoximetasone 0.25% emollient cream or mometasone cream
0.1% as per dermatologist’s discretion and approved Prescribing Information
4. Patients/ Legally Authorized Representative (LAR) willing to give written informed
consent 
 
ExclusionCriteria 
Details  1. Patients with history of hypersensitivity to any of the components of study medication
preparations.
2. Pregnant and nursing women
3. Patients with documented comorbid systemic disorders of the cardiovascular, central
nervous, gastrointestinal, respiratory systems, hormonal disorders, and chronic
inflammatory conditions, which, in the opinion of the investigator may have a potential
health risk to the patient.
4. Patients consuming oral immunosuppressive medications including oral
corticosteroids, etc prior to 3 weeks of study.
5. Patients with documented disorders related to present or past history of abnormal
activity of Hypothalamo-pituitary-adrenal axis. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients developing adverse events with Desoximetasone 0.25% emollient cream during the 3 week treatment period in comparison to mometasone cream and nature of adverse events  Days 14 and 21 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of patients showing treatment success as assessed by Physicians’ Global
Assessment (PGA) score at Day 14 and Day 21 from baseline. 
Day 14 and 21 
Change in Visual Analog Scale (VAS) for perception of improvement in intensity of pruritus at
Day 14 and Day 21 from baseline 
Baseline, Days 14 and 21 
Change in Eczema Area and Severity Index (EASI) score at Day 14 and Day 21  Baseline, Days 14 and 21 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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   N/A 
Date of First Enrollment (India)   15/03/2018 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This prospective, observational, multi-center, post marketing surveillance study has been planned to gather real-world clinical comparative data on the effectiveness and safety of desoximetasone emollient cream versus mometasone cream in 180 Indian patients suffering from eczema. The objective of the study is to evaluate the safety of Desoximetasone 0.25% emollient cream in comparison to mometasone cream 0.1% in patients with eczema during 3 weeks of therapy. Safety will be assessed as the proportion of patients suffering from adverse events during the study and the nature of the adverse events. The effectiveness will be assessed by proportion of patients showing treatment success as assessed by Physicians’ Global Assessment (PGA) score at Day 14 and Day 21 from baseline, change in Visual Analog Scale (VAS) for perception of improvement in intensity of pruritus at
Day 14 and Day 21 from baseline, and change in Eczema Area and Severity Index (EASI) score at Day 14 and Day 21. The study will be conducted at 9 sites in India over a study duration of 6 months. The inclusion criteria will be - 1. Patients >10 years of age of either gender who are capable of complying with protocol requirements 2. Newly diagnosed, treatment-naïve patients with clinical diagnosis of eczema 3. Patients treated with desoximetasone 0.25% emollient cream or mometasone cream 0.1% as per dermatologist’s discretion and approved Prescribing Information 4. Patients/ Legally Authorized Representative (LAR) willing to give written informed consent. The exclusion criteria will be 1. Patients with history of hypersensitivity to any of the components of study medication preparations. 2. Pregnant and nursing women 3. Patients with documented comorbid systemic disorders of the cardiovascular, central nervous, gastrointestinal, respiratory systems, hormonal disorders, and chronic inflammatory conditions, which, in the opinion of the investigator may have a potential health risk to the patient.4. Patients consuming oral immunosuppressive medications including oral corticosteroids etc prior to 3 weeks of study.5. Patients with documented disorders related to present or past history of abnormal activity of Hypothalamo-pituitary-adrenal axis. Patient’s information and demographics will be recorded. In demographics, the age, sex, and comorbid conditions will be noted. The severity of disease and extent of body involvement will be noted by the investigator. The severity of disease will be assessed by grading (0 - None, 1 – Mild, 2- Moderate, 3 -Severe) for each signs viz. erythema, edema/population, excoriation and lichenification in 4 different regions of head/neck, trunk, upper and lower extremities. For each region, the average of severity will be considered. For assessing the extent of the disease, percentage involvement of each of the 4 regions will be noted. From this data, EASI score will be calculated. Patient’s response to intensity of pruritus will be noted using a VAS score.
 
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