| 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
|
|
|
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
|
|
|
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. |