| CTRI Number |
CTRI/2010/091/000482 [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 study to study the effects of a cream containing a fixed -dose of Halobetasol propionate and Fusidic acid in patients with infected dermatoses |
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Scientific Title of Study
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ASSESSMENT OF EFFICACY, SAFETY AND TOLERABILITY OF FIXED DOSE COMBINATION OF HALOBETASOL 0.05% PLUS FUSIDIC ACID 2% CREAM IN PATIENTS WITH INFECTED DERMATOSES |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| Protocol no 001/GL/HFU/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
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| Name |
Dr Chandrashekhar S 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 |
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| Email |
chandrashekharb@glenmarkpharma.com |
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Details of Contact Person
Public Query
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| Name |
Dr Chandrashekhar S Bolmall |
| Designation |
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| 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 = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr C Udayashankar |
Aarupadai Veedu Medical College and Hospital |
Cuddalore Main Road,Kirumpakkam-607402
Pondicherry
PONDICHERRY |
09944122744
udayderm@yahoo.com |
| Dr Sanjay Ghosh |
Institute of Allergic and Immunologic Skin Disease |
Bakultala Lane, ,Kasba-700042
Kolkata
WEST BENGAL |
033-24428011
drsanjayghosh1@gmail.com |
| Dr B Parveen |
Madras Medical College |
Prof. & Head, Dept. of Dermatology,-600003
Chennai
TAMIL NADU |
044 - 2530 5000
drbparveen@gmail.com |
| Dr D G Saple |
Skin and STD Clinic |
88, Hindu Colony,Dadar-400014
Mumbai
MAHARASHTRA |
022-24143895
drsaple@drsaple.com |
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Details of Ethics Committee
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| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| IAISD Ethical Committee, Kolkata |
Approved |
| ICMR IEC/IRB |
Approved |
| IEC of Govt General Hospital and Madras Medical College |
Approved |
| Independent Ethics Committtee |
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 |
Infected Dermatoses, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Halobetasol 0.05% + Fusidic acid 2%Cream |
To be applied twice daily as a thin film and rubbed in gently and copletely with a gap of 12 hours between each application. |
| 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 halobetasol or Clobetasol or salicylic acid or ointment base.
Immunocompromised 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 |
| CHANGES IN MEAN SCORE OF CLINICAL SIGNS AND SYMPTOMS AFTER THE TREATMENT |
Baseline, 4-6 days and 8-10 days |
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Secondary Outcome
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| Outcome |
TimePoints |
| GLOBAL ASSESSMENT OF EFFICACY OF TREATMENT BY PHYSICIANS AND PATIENTS RESPECTIVELY
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Day 8-10 |
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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)
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Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/09/2008 |
| 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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The present study was undertaken to assess the efficacy, safety and tolerability of Fixed Dose Combination of Halobetasol 0.05%+Fusidic acid 2%cream in infected dermatoses.
In this prospective, multicentric open-label study patients were asked to apply Halobetasol 0.05% plus Fusidic acid 2% cream twice daily. 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.
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