| CTRI Number |
CTRI/2010/091/000483 [Registered on: 25/05/2010] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Single Arm Study |
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Public Title of Study
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A Clinical Trial to study the effects of a fixed dose cream formulation of Mometasone 0.1% +Fusidic acid 2% in patients with steroid responsive dermatoses with secondary bacterial infections |
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Scientific Title of Study
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ASSESSMENT OF EFFICACY, SAFETY AND
TOLERABILITY OF FIXED DOSE COMBINATION OF MOMETASONE 0.1% + FUSIDIC ACID 2% IN TREATMENT OF PATIENTS WITH CORTICOSTEROID-RESPONSIVE DERMATOSES WITH SECONDARY BACTERIAL INFECTIONS
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| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| 002/GL/MFU/08 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
Not Applicable
N/A
India |
| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrashekhar Bolmall |
| Designation |
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| Affiliation |
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| Address |
Medical Services department
Glenmark Pharmaceuticals Ltd, Chakala, Andheri(East)
Mumbai
MAHARASHTRA
400099
India |
| Phone |
022-40189999 |
| Fax |
|
| Email |
chandrashekharb@glenmarkpharma.com |
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Details of Contact Person
Public Query
|
| Name |
Dr Chandrashekhar Bolmall |
| Designation |
|
| Affiliation |
|
| Address |
Medical Services department
Glenmark Pharmaceuticals Ltd, Chakala, Andheri(East)
Mumbai
MAHARASHTRA
400099
India |
| Phone |
022-40189999 |
| Fax |
|
| Email |
chandrashekharb@glenmarkpharma.com |
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Source of Monetary or Material Support
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| Glenmark Pharmaceuticals Ltd. |
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Primary Sponsor
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| Name |
Glenmark Pharmaceuticals Ltd. |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr V Sivaraman |
Eastcoast Hospital Ltd |
Consultant Dermatologist,No 8- B Lenin Street Kosapalayam-605 013
Pondicherry
PONDICHERRY |
0413-2228890
sivaramanv@yahoo.com |
| Dr S Jayakumar |
Government General Hospital and Madras Medical College |
Addl Prof Of Dermatology,Madras Medical College & Govt. General Hospital-600010
Chennai
TAMIL NADU |
09444147153
drsjayakumar1@yahoo.com |
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Details of Ethics Committee
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| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Eastcoast Hospital |
Approved |
| Govt. General Hospital & Madras Medical College |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Corticosteroid -responsive dermatoses with secondary bacterial infections, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
MOMETASONE 0.1% PLUS FUSIDIC ACID 2% CREAM |
Cream to be applied over the affected area/s twice daily as a thin film and rubbed in gently and completely, with each application separated by about 12 hours |
| Comparator Agent |
Nil |
Not Applicable |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
Male & female (post-menopausal, surgically sterilized or practicing a reliable method of birth control) patients with age ranging from 12 to 65 years.
Clinical diagnosis of patients with infected dermatoses
Written informed consent by patient.
Patient willing to follow up. |
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| ExclusionCriteria |
| Details |
Pregnant and lactating women.
Serious skin disorders, dyspigmentation and extensive scarring in the affected areas.
Hypersensitivity to Mometasone or Fusidic acid or cream base.
Immuno-compromised states and patients with systemic infections.
Patients who have participated in a new drug study in the past 6 months.
Patients with severe cardiac, hepatic, renal, or cerebrovascular disease, malignancy, chronic uncontrolled systemic diseases e.g., diabetes, hypertension, asthma, collagen disorders, etc. or any other serious medical illness.
Any other condition that in the opinion of the investigator does not justify the patient?s participation in the study. |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Pre-numbered or coded identical Containers |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| Clinical signs and symptoms, Severity of lesions, discharge from lesions. |
Baseline, Days 6-7 and Days 13-14 |
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Secondary Outcome
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| Outcome |
TimePoints |
| Global assessment of efficacy of treatment by Physicians and patients |
End of the study |
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Target Sample Size
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Total Sample Size="100"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/12/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="0"
Months="3"
Days="0" |
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Recruitment Status of Trial (Global)
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Completed |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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In this prospective, multicentric open-label study 115 patients with secondary bacterial infections associated with corticosteroid-responsive dermatoses were asked to apply a fixed dose combination of Mometasone0.1% + Fusidic acid 2% cream. Efficacy parameters included assessment of clinical signs and symptoms, severity and discharge from lesions and bacteriological findings. Overall global assessment of efficacy was undertaken by physicians and patients. Safety and tolerability was also assessed. |