CTRI/2012/03/002472 [Registered on: 05/03/2012] Trial Registered Prospectively
Last Modified On:
31/12/2012
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical trial to study the effect of Fixed Dose Combination of Microsphere Tretinoin and Clindamycin gel in the treatment of patients with acne vulgaris.
Scientific Title of Study
A Multicenter, Double-Blind, Randomized, Parallel-Group, Comparative Study to Evaluate Efficacy, Safety and Tolerability of a Fixed Dose Combination of Microsphere Tretinoin 0.1% and Clindamycin 1.2% Gel Compared to Individual Components of the Fixed Dose Combination in Patients with Acne Vulgaris
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
GPL/CT/2011/003/III, version no.1.0, dated: 13.09.2011
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Dr Piyush Agarwal
Designation
Deputy General Manager
Affiliation
Glenmark Pharmaceuticals Ltd
Address
Glenmark Pharmaceuticals Ltd
Glenmark House, B D Sawant Marg
Chakala, Andheri(East)
Mumbai MAHARASHTRA 400099 India
Phone
912240189999
Fax
Email
piyusha@glenmarkpharma.com
Details of Contact Person Public Query
Name
Dr Shailendra Sachan
Designation
Manager-Clinical Research
Affiliation
Glenmark Pharmaceuticals Ltd
Address
Glenmark Pharmaceuticals Ltd
Glenmark Research Centre,
Plot No. A-607, T.T.C. Industrial Area,
MIDC, Mahape, Navi Mumbai
Thane MAHARASHTRA 400709 India
Phone
912267720000
Fax
Email
shailendrasachan@glenmarkpharma.com
Source of Monetary or Material Support
Glenmark Pharmaceuticals Ltd
Primary Sponsor
Name
Glenmark Pharmaceuticals Ltd
Address
Glenmark Pharmaceuticals Ltd
Glenmark House, B D Sawant Marg
Chakala, Andheri(East), Mumbai, India-400 099
Dr. Sailaja Kaza Institute & Dr. Surapaneni’s Asthetic Surgery Institute
Dr. Sailaja Kaza Institute & Dr. Surapaneni’s Asthetic Surgery Institute
#8-2-684/1/8 & 11/1, Bhavani Enclave, Road No-12, Banjara Hills, Hyderabad
Hyderabad ANDHRA PRADESH
919849991337
sailajakaza@yahoo.com
Dr Manisha Nijhawan
Mahatma Gandhi Medical College & Hospital
Department of Dermatology
Mahatma Gandhi Medical College & Hospital
RIICO Institutional Area, Sitapura, Tonk Road, Jaipur
Jaipur RAJASTHAN
01411771777
clinicalresearch@mgmch.org
Dr Balaram Ghosh
Medical College, Kolkata
Department of Clinical Pharmacology
Medical College, Kolkata, 88, College Street, Govt of West Bengal, Kolkata Kolkata WEST BENGAL
919432876733
drbrghosh@gmail.com
Dr Aruna Prasad
Pace Clinical Research
Pace Clinical Research
(A unit of Pranav Diabètes Centre) No : 57/1, Nanda Complex, Ramamurthy Nagar Main Road, Banaswadi, Bangalore
Bangalore KARNATAKA
080-41626643
paceclinicalresearch@gmail.com
Dr Rajendra Singh
Pardaya Memorial Hospital
Pardaya Memorial Hospital
Malpura Road, Sanganer, Jaipur
Jaipur RAJASTHAN
01412732914
pardaya@rediffmail.com
Dr Srujana Lekkala
Sai Poly Clinic
Sai Poly Clinic,
Opp. Sanath Nagar Main Bus Stop, Hyderabad
Hyderabad ANDHRA PRADESH
919908062364
srujana_99@yahoo.com
Dr Nagesh Tumkur Subbarao
Sapthagiri Hospital
Sapthagiri Hospital
#15, Chikkasandra, Hesaraghatta Main Road, Bangalore
Bangalore KARNATAKA
Virtuous Independent Ethics Committee Hyderabad, Dr. Sailaja Kaza Institute & Dr. Surapaneni’s Asthetic Surgery Institute, Hyderabad
Submittted/Under Review
VZ Human Research Protection Care, Visakhapatnam Dayal Clinic, Visakhapatnam
Approved
VZ Human Research Protection Care, Visakhapatnam Doctors & Doctors, Visakhapatnam
Approved
VZ Human Research Protection Care, Visakhapatnam Sri Gayatri Skin Care & Hair Care Centre, Visakhapatnam
Approved
VZ Human Research Protection Care, Visakhapatnam Touch Clinic, Visakhapatnam
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Acne Vulgaris,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
1. Clindamycin 1% Gel.
once daily application at bedtime on face and effected area for 12 weeks
Comparator Agent
2. Microsphere Tretinoin 0.1% Gel
once daily application at bedtime on face and effected area for 12 weeks
Intervention
Fixed Dose Combination of Microsphere Tretinoin 0.1% and Clindamycin 1.2% Gel
once daily application at bedtime on face and effected area for 12 weeks
Inclusion Criteria
Age From
12.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Male or female ≥12 to <65 years and willing to give their written informed consent.
2. An Investigator’s Static Global Assessment (ISGA) Score of 2 or greater at baseline
3. Subjects must have both:
a) A minimum of 17 but no more than 40 facial inflammatory lesions;
b) A minimum of 20 but not more than 150 facial non-inflammatory lesions
4. The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
5. Female participants must have a negative pregnancy test at screening visit and willing to use acceptable contraceptive measures during the study.
6. The ability to understand and sign written informed consent form, which must have been obtained prior to applying the study product. Subjects under the legal age of consent must provide assent and have the written informed consent of the parent or guardian.
ExclusionCriteria
Details
1. Pregnant or lactating women.
2. Patient with known hypersensitivity to any of the components of the formulation.
3. Patients with severe eczema
4. Patients with any nodulo-cystic lesions at baseline.
5. History or presence at entry of regional enteritis or inflammatory bowel disease or similar symptoms.
6. A significant medical history of or are currently immunocompromised.
7. Used any investigational therapy with in the 4 weeks prior to entry.
8. Current drug or alcohol abuse at the time of entry
9. Any other condition which, in the judgment of the investigator, would put the Patient at unacceptable risk for participation in the study.
10. Patient who has clinical laboratory evaluations (including biochemistry, hematology, and complete urinalysis) that are not within the reference range for the testing laboratory at Screening and the results are deemed clinically significant by the investigator.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
1. Absolute Change in Lesion counts
2. Investigator’s Static Global Assessment Success
12 weeks
Secondary Outcome
Outcome
TimePoints
1. Percentage change in lesion counts
12 weeks
2. Proportion of patients who had a Subject Global Assessment Score of 0 or 1
12 weeks
3. Proportion of Patients who had an ISGA Score of 0 or 1
12 weeks
4. Change in Vital signs, Physical Exam. & Lab Parameters
12 weeks
Target Sample Size
Total Sample Size="438" Sample Size from India="438" Final Enrollment numbers achieved (Total)= "" Final Enrollment numbers achieved (India)=""
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is double-blind, randomized, active controlled, three arm, parallel-group, comparative study. Study will enroll 438 patients with acne vulgaris across the different centers from India.
Patients will be recruited after providing written informed consent. After screening, patients will be randomized (meeting randomization criteria) in 1:1:1 ratios to receive either Fixed Dose Combination of Microsphere Tretinoin and Clindamycin gel or Clindamycin gel or Microsphere Tretinoin gelfor twelve weeks. The primary objective of the study is to see the absolute change in lesion counts and Investigator’s Static Global Assessment success. Secondary objective includes; percentage change in lesion counts, proportion of patients who had a Subject Global Assessment Score of 0 or 1 at Week 12, proportion of patients who had an ISGA score of 0 or 1 at Week 12 and safety evaluation.
During the study, there will be 5 study visits at day 1, week 2, 4, 8 and 12 for efficacy, safety and tolerability assessment.