| CTRI Number |
CTRI/2010/091/000178 [Registered on: 23/02/2010] |
| 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 |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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A clinical trial to study the effect of a fixed dose formulation of Sertaconazole + Beclomethasone and miconazole nitrate in patients with tinea infections associated with inflammatory skin conditions.
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Scientific Title of Study
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Comparative assessment of efficacy, safety and tolerability of Sertaconazole nitrate 2% plus Beclomethasone dipropionate 0.025% cream vs Miconazole nitrate 2% cream in Patients with Tinea Infections Associated with Inflammatory Dermatoses |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| 001/09 Version : GL/SER+Beclo/09 |
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 |
Chandrashekhar S Bolmall |
| Designation |
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| Affiliation |
Medical Services Department |
| Address |
Glenmark Pharmaceuticals Ltd., Glenmark House, B D Sawant Marg
Chakala, Andheri(East)
Mumbai
MAHARASHTRA
400099
India |
| Phone |
91-22-40189999 |
| Fax |
91-22-40189990 |
| Email |
chandrashekharb@glenmarkpharma.com |
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Details of Contact Person
Public Query
|
| Name |
Chandrashekhar S Bolmall |
| Designation |
|
| Affiliation |
|
| Address |
Glenmark Pharmaceuticals Ltd., Glenmark House, B D Sawant Marg
Chakala, Andheri(East)
Mumbai
MAHARASHTRA
400099
India |
| Phone |
91-22-40189999 |
| Fax |
91-22-40189990 |
| 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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| Name |
Address |
| Glenmark Pharmaceuticals Ltd. |
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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 = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Bela J.Shah |
B.J.Medical College & Civil Hospital |
Prof. & HOD, Dept. of Dermatology,-380016
Ahmadabad
GUJARAT |
09898059289
shah.drbela@gmail.com |
| Dr. A. Gnaneshwar Rao |
Gandhi Medical College & Gandhi Hospital |
Prof. & HOD, Dept. of Dermatology,-500003
|
09848011159
dr_a_g_rao@yahoo.co.in |
| Dr. M.M. Kura |
GMC & Sir JJ Group of Hospitals |
Prof. & HOD, Dept. of Dermatology,-400008
Mumbai
MAHARASHTRA |
09322593511
drkura@gmail.com |
| Dr. H. Jerajani |
LTMMedical College & LT Memorial General Hospital |
Prof. & HOD, Dept. of Dermatology,Sion-400022
Mumbai
MAHARASHTRA |
0982031483
jerajani@rediffmail.com |
| Dr. D. Prabhavathy |
Madras Medical College |
Prof. & HOD, Dept. of Dermatology,,-600003
Chennai
TAMIL NADU |
09444010694
d-prabhavathy@hotmail.com |
| Dr. Uday Khopkar |
Seth G S Medical College & KEM Hospital |
Prof. & HOD, Dept. of Dermatology,Parel-400012
Mumbai
MAHARASHTRA |
022-24107538
drkhopkar@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| B.J.Medical College & Civil Hospital |
Approved |
| G M College & Gandhi Hospital |
Approved |
| GMC & JJ Group of Hospitals |
Approved |
| GMC & JJ Group of Hospitals |
Approved |
| LTMM College and LTMG Hospital Staff Research Society |
Approved |
| Madras Medical College |
Approved |
| Seth G S Medical College and KEM Hospital Research Society |
Submittted/Under Review |
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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 |
Tinea Infections Associated with Inflammatory Dermatoses, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Miconazole nitrate 2% cream |
Every 12 hours topical |
| Intervention |
Sertaconazole nitrate 2 % plus Beclomethasone dipropionate 0.025% cream |
Every 12 hours topical |
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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 18 to 70 years;Clinical diagnosis of tinea infections, confirmed by laboratory evaluation (microscopic examination confirmed by a positive potassium hydroxide [KOH] test) with inflammatory dermatoses;Written informed consent by patient; Patient willing to follow up. |
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| ExclusionCriteria |
| Details |
Pregnant or lactating women;Patients who had received oral treatment with antimycotics during the 4 weeks preceding the trial or topical treatment during the week before; Patients with compromised immunity (patients taking steroid, immunosuppresants or with HIV/AIDS;Applied topical antifungal therapy to the feet within 14 days of study or had been treated with oral antifungal therapies within 3 months of study entry;Hypersensitivity to Sertaconazole nitrate, beclomethasone dipropionate, miconazole or base of cream; 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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Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Clinical evaluation of the disease assessed in accordance with the clinical scale; Mycologic assessment;Physician |
Baseline, Days 7, 14 and 28 |
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Secondary Outcome
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| Outcome |
TimePoints |
| Global assessment of clinical response; Overall response at 4 week |
End of study |
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Target Sample Size
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Total Sample Size="200"
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/ Phase 4 |
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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) |
08/03/2010 |
| 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="6"
Days="0" |
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Recruitment Status of Trial (Global)
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Not Yet Recruiting |
| 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 study is awaiting ethics commiittee approval at some sites |