| CTRI Number |
CTRI/2019/11/021908 [Registered on: 07/11/2019] Trial Registered Prospectively |
| Last Modified On: |
28/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Study to evaluate the Efficacy and Safety of MEZO cream with ELOCON Cream in the treatment of plaque psoriasis
|
|
Scientific Title of Study
|
A Prospective Interventional Randomized Parallel Double blind Comparative Clinical Study to evaluate the Efficacy and Safety of MEZO cream 0.1 % (Mometasone Furoate USP 0.1%) with ELOCON Cream 0.1%
(Mometasone Furoate 0.1%) in the treatment of plaque psoriasis
|
| Trial Acronym |
ICBio-CR-APL-0620-95 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/CR/APL/0620-95 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hitalkumar Patel |
| Designation |
Dermatologist |
| Affiliation |
The skin Artistry |
| Address |
The skin artistry
102 solitaire complex opp galaxy bazar
Ahmedabad
Ahmadabad
GUJARAT
380054
India |
| Phone |
9824601777 |
| Fax |
|
| Email |
H.R.Patel@Doctor.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harisha S |
| Designation |
Director |
| Affiliation |
ICBio Clinical Research Pvt Ltd |
| Address |
16 and 18 ICBio Tower
Yelahanka Main Road
Chikkabettahalli Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
09900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harisha S |
| Designation |
Director |
| Affiliation |
ICBio Clinical Research Pvt Ltd |
| Address |
16 and 18 ICBio Tower
Yelahanka Main Road
Chikkabettahalli Vidyaranyapura
Bangalore
KARNATAKA
560097
India |
| Phone |
09900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| AGIO PHARMACEUTICALS LTD
H O A 38 Nandjyot Industrial Estate
Kurla Andheri Road Safedpool Mumbai 400072 India
|
|
|
Primary Sponsor
|
| Name |
AGIO PHARMACEUTICALS LTD |
| Address |
AGIO PHARMACEUTICALS LTD
H O A 38 Nandjyot Industrial Estate
Kurla Andheri Road Safedpool Mumbai 400072 India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hitalkumar Patel |
The Skin Artistry |
102 solitaire complex opp galaxy bazar Ahmedabad gujarat india
Ahmadabad
GUJARAT |
9824601777
H.R.Patel@Doctor.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sangini Hospital Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00||Staphylococcal scalded skin syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ELOCON® cream 0.1% (Mometasone Furoate 0.1%) |
Once a day in the evening
Method of application
A thin film of Mometasone Furoate USP 0.1 % Cream should be applied to the affected areas of skin once daily.
One fingertip unit is enough to cover an area twice the size of an adult hand.
|
| Intervention |
MEZO cream |
Mometasone Furoate USP 0.1% w/w
Method of application
A thin film of Mometasone Furoate USP 0.1 % Cream should be applied to the affected areas of skin once daily
One fingertip unit (a line from the tip of an adult index finger to the first crease) is enough to cover an area twice the size of an adult hand
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adults of both sexes
Age 18 or older with good mental health
Psoriasis patients with mild to moderate as classified by investigator based on body surface area
Mild to moderate psoriasis means that the red scaly patches plaques cover less than 10 percent of your body
Subject who in the opinion of the investigator are free of any medical condition s that may interfere with study participation or affect study measures
Willing to provide written informed consent for participation in the study and adhere to the protocol requirements
Patients who agreed to return for follow-up visits
|
|
| ExclusionCriteria |
| Details |
Patients who are not willing to give written informed consent
Patients who also had psoriatic plaques of skin disorders caused by fungi or bacteria and they were making use of antibiotic or antifungal
Other types of skin damage that was not psoriasis
Pregnant and nursing women
Patients using oral anticoagulants
Any finding of clinical observation that is interpreted by the investigator as a risk to the patients participation in the study
7. Severely immune compromised patients
Use of any investigational drug currently or within 30 days prior to study entry
Subjects on any prescription medication that might interfere with study outcomes
History of alcohol or drug abuse
Patients having Impetigo cellulitis lymphangitis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the improvement in psoriatic sign and symptoms using a scale
Parameters will be evaluated for erythema plaque size Scaling itching thickness of the lesion |
baseline EOT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Self Assessment of General Health
Tolerance
To evaluate the quality of life
Assessment of safety of the Investigational products
Adverse event
Physical examination
Biomarker of systemic safety
Hematological test
Liver function test
Renal function test Serum creatinine
RBS
|
baseline to EOT |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
07/11/2019 |
| Date of Study Completion (India) |
15/06/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="12" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
“A Prospective, Interventional, Randomized, Parallel, Double blind, Comparative, Clinical Study to evaluate the Efficacy & Safety of MEZO cream 0.1% (Mometasone Furoate USP 0.1%) with ELOCON® Cream, 0.1% (Mometasone Furoate 0.1%) in the treatment of plaque psoriasis.’’
| Total of 60 subjects Test: - 30 subjects [MEZO cream 0.1% (Mometasone Furoate USP 0.1%)] Reference: - 30 subjects [ELOCON® cream 0.1% (Mometasone Furoate 0.1%)] -Male and Female subjects having age 18 and above will be enrolled in the study.
| -Psoriasis patients with mild to moderate as classified by investigator based on body surface area. [Mild to moderate psoriasis means that the red, scaly patches ("plaques") cover less than 10% of your body] The study duration is 72 days (Around 10 weeks (6 weeks treatment plus follow up after 1 month)) |
| |