FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/08/027413 [Registered on: 27/08/2020] Trial Registered Prospectively
Last Modified On: 18/02/2022
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   The safety and Effectiveness of Botulinum Toxin Type A used for treatment of Moderate to Severe Facial Wrinkles 
Scientific Title of Study   A Multi Center Prospective Single Arm Post Market Surveillance Study to Evaluate the Safety and Efficacy of Botulinum Toxin Type A in Management of Moderate to Severe Facial Wrinkles 
Trial Acronym  GB_BOT_001_20 
Secondary IDs if Any  
Secondary ID  Identifier 
GB_BOT_001_20  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rohit Batra 
Designation  Consultant Dermatologist 
Affiliation  Dermaworld Skin and Hair Clinics 
Address  Dermaworld Skin & Hair Clinics D-152, First Floor Next HDFC Bank, Main Shankar Rd, New Rajinder Nagar, New Delhi, Delhi-110060

New Delhi
DELHI
110060
India 
Phone  9911200050  
Fax    
Email  drrohitbatra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Adarsh Shetty 
Designation  Senior Manager, Medical Affairs 
Affiliation  Gufic Biosciences Limited 
Address  Subhash Road B Block, Vile Parle East Mumbai, Maharashtra

Mumbai
MAHARASHTRA
400057
India 
Phone    
Fax    
Email  medicalaffairs@guficbio.com  
 
Details of Contact Person
Public Query  
Name  Dr Adarsh Shetty 
Designation  Senior Manager, Medical Affairs 
Affiliation  Gufic Biosciences Limited 
Address  Subhash Road B Block, Vile Parle East Mumbai, Maharashtra

Mumbai
MAHARASHTRA
400057
India 
Phone    
Fax    
Email  medicalaffairs@guficbio.com  
 
Source of Monetary or Material Support  
Gufic Biosciences Limited, Subhash Road-A Block, Vile Parle East Mumbai, Maharashtra- 400057  
 
Primary Sponsor  
Name  Gufic Biosciences Limited 
Address  Subhash Road - A Block, Vile Parle East Mumbai, Maharashtra, India 400057 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jayaraman AM  Chennai Meenakshi Multispeciality Hospital  Old 148, New 72, Luz Church Road, Mylapore, Chennai 600004
Chennai
TAMIL NADU 		 9444119274

researchchennaimeenakshi@gmail.com 
Dr Rohit Batra  Dermaworld Skin and Care Clinics  D-152, first floor, Next to HDFC Bank, Main Shankar RD, New Rajinder Nagar,New Delhi 110060
New Delhi
DELHI 		 9911200050

drrohitbatra@gmail.com 
Dr Sushil Tahiliani  Dr. Tahiliani’s Clinic  A 202-202, Gasper Enclave, B.R. Ambedkar Road, Pali Naka, Bandra (W), Mumbai- 400050, Maharashtra India
Mumbai
MAHARASHTRA 		 9820492415

drsushiltt@gmail.com 
Dr Rachita Dhurat  RD Clinic  204 Shubham Flora, Chembur Naka, Chember, Mumbai 400071
Mumbai
MAHARASHTRA 		 9833394951

rachitadhurat@yahoo.co.in 
Dr Mrunal Shah Modi  Shine Skin, Hair & Laser Clinic  Shine Skin, Hair & Laser Clinic, 412, Jolly Bhavan-2,Opp. Nirmala Niketan College, Churchgate,Mumbai, Maharashtra- 400020, India
Mumbai
MAHARASHTRA 		 9820547525

shah_mrunal@yahoo.com 
Dr Himanshu Gupta  Skin Konnect (Skin Clinic)  Shop no-8, DDA Market (CSC-I, B Block, Yoajan Vihar, Delhi 1100092
New Delhi
DELHI 		 9891663366

skinkonnect@gmail.com 
Dr Sumit Gupta  Skinnovation Clinics Skin Clinic  B 11, Part 1, Gujranwala Town, Near Model Town metro station, Ring Road, New Delhi 110009
New Delhi
DELHI 		 981134150

drsg87@gmail.com 
Dr Madhuri Tadepalli  Transform skin and cosmetology clinic  Flora apartments, Beside almond house, OPP- SBI Banjara Hills, Road no-3, Hyderabad 500034
Hyderabad
TELANGANA 		 9849939526

drmadhuri289@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Chennai Meenakshi Multispeciality Hospital Ethics Committee  Approved 
Good Society of Ethical Research  Approved 
Good Society of Ethical Research  Approved 
Good Society of Ethical Research  Approved 
Harmony Ethical Research Committee  Approved 
Harmony Ethical Research Committee  Approved 
Harmony Ethical Research Committee  Approved 
Naithika Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Botulinum Toxin Type A  BP 50/100 Unit,Injection for 4 Months (120 Days) 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1) Male/Femles of 30-50 years of age
2) Subject who can and willing to provide written informed conscent
3)Subjects motivated and aesthetically conscious with moderate to severe facial wrinkles
4)Females of child bearing potential must have negative urine pregnancy test, must be practicing a medically acceptable method of birth control and not lactating
 
 
ExclusionCriteria 
Details  1)Subjects with a known severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies
2) Subjects with a known allergy or sensitivity to any of the study medication or their components
3) Subjects having a mental or physical condition that would, in the opinion of the investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol
4) Subjects has participated in another clinical study involving another investigational agent within 4 weeks of the start of this trial, or is planning participation in another clinical trial during the current study duration
5) Subjects with a history of vision loss not corrected by lenses, or LASIX surgery, glaucoma, retinal detachment, macular degeneration, history of multiple sclerosis or optic neuritis, or any uncontrolled eye disease 6) Subjects with acute infection 7. Subject with myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other disease that might interfere with neuromuscular function
8) Concurrent use of aminoglycoside antibiotics that interfere with neuromuscular function
9) Subjects with history of previous injection of botulinum Toxin within eight months
10) Subjects with severe thin skin in treatment area as determined by the investigator
11) Subjects with infection at the injection site
12) Subjects having received anticoagulation, anti-platelet and thrombolytic treatment (eg Warfarin), anti-inflammatory drugs (NSAIDs aspirin, Ibuprofen, etc) or any other substance known to increase the coagulation time from 10 days pre to 3 days post injection 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the safety of Botulinum Toxin Type A  4 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of efficacy   4 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   01/09/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study is a Multi-Center, Prospective, Single Arm, Post Market Surveillance Study to Evaluate the Safety & Efficacy of Botulinum Toxin Type A in Management of Moderate to Severe Facial Wrinkles for Four months (120 days) in 100 patients with severe facial wrinkles. Subjects will complete a screening visit (V1) to determine eligibility for the study based on Inclusion & Exclusion Criteria, medical history and safety measures. The primary end point is Evaluation of safety will include assessment of safety of the formulation with respect to adverse events. Evaluation of efficacy will include: Proportion of subjects reported by the investigator at least ‘improved’ on ‘Modified Global Aesthetic Improvement Scale (GAIS)’ at the end of study visit, Proportion of subjects self-reported at least ‘improved’ on ‘Modified Global Aesthetic Improvement Scale (GAIS)at the end of study visit, Comparison of subject’s Self-perception of age will be done between baseline and end of study visit. The rating will be reported as I look my current age, I look _ years younger, or I look _ years older. 
Close