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CTRI Number  CTRI/2013/11/004155 [Registered on: 20/11/2013] Trial Registered Retrospectively
Last Modified On: 29/10/2013
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effects of two drugs, 5-Fluorouracil and bleomycin in patients with keloids and hypertrophic scars. 
Scientific Title of Study   EFFICACY AND SAFETY OF INTRALESIONAL BLEOMYCIN IN COMPARISION TO COMBINATION OF INTRALESIONAL 5-FLUOROURACIL AND TRIAMCINOLONE ACETONIDE IN PATIENTS OF KELOID AND HYPERTROPHIC SCARS: A RANDOMISED, OPEN LABELLED, COMPARATIVE STUDY. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mugdha Jhamwar 
Designation  resident doctor in Dermatology, Venereology and Leprosy 
Affiliation  Government Medical College and Sir. T. Hospital, Bhavnagar. 
Address  Department of Dermatology,Venereology and Leprosy, Room no. 115, New OPD building, Sir. T. Hospital, Bhavnagar
Government Medical College- Bhavnagar, Near S.T. Stand, Jail Road, Bhavnagar- 364002. Gujarat.
Bhavnagar
GUJARAT
364001
India 
Phone  9099972972  
Fax  0278-2422011  
Email  mugdha.jhamwar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hita Shah 
Designation  Professor and Head in Dermatology, Venereology and Leprosy 
Affiliation  Government Medical College and Sir. T. Hospital, Bhavnagar. 
Address  Department of Dermatology,Venereology and Leprosy, Room no. 115, New OPD building, Sir. T. Hospital, Bhavnagar
Government Medical College- Bhavnagar, Near S.T. Stand, Jail Road, Bhavnagar- 364002. Gujarat.
Bhavnagar
GUJARAT
364001
India 
Phone  9429503188  
Fax  0278-2422011  
Email  dr_hitashah07@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Mugdha Jhamwar 
Designation  resident doctor in Dermatology, Venereology and Leprosy 
Affiliation  Government Medical College and Sir. T. Hospital, Bhavnagar. 
Address  Department of Dermatology,Venereology and Leprosy, Room no. 115, New OPD building, Sir. T. Hospital, Bhavnagar
Government Medical College- Bhavnagar, Near S.T. Stand, Jail Road, Bhavnagar- 364002. Gujarat.
Bhavnagar
GUJARAT
364001
India 
Phone  9099972972  
Fax    
Email  mugdha.jhamwar@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College, Behind S.T. Stand , Jail Road, Bhavnagar 364001 (Gujarat) India. 
 
Primary Sponsor  
Name  Government Medical College Bhavnagar 
Address  Government Medical College, Behind S.T. Stand , Jail Road, Bhavnagar 364001 (Gujarat) India. 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrMugdha Jhamwar  Sir. T. Hospital and Government Medical College, Bhavnagar  Department of Dermatology,Venereology and Leprosy, Room no. 115, New OPD building, Sir. T. Hospital, Bhavnagar
Bhavnagar
GUJARAT 
09099972972

mugdha.jhamwar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board ( Human Ethics Committee), Government Medical College, Bhavnagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  keloids and Hypertrophic scars,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  5 Fluorouracil with triamcinolone acetonide  intralesional Injection 5 Fluorouracil 50mg per ml with triamcinolone acetonide 10 mg per ml in ratio of 9 each to 1 weekly for 15 weeks  
Comparator Agent  Bleomycin  Intralesional Injection Bleomycin 1.5 mg per ml three weekly for 15 weeks 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  patients with keloid or hypertrophic scar with
• No history of treatment taken for keloids or hypertrophic scar for at least 3 months.
• Scar size less than or equal to 15 cm in all dimensions.
• Scar duration more than or equal to 6 weeks.
 
 
ExclusionCriteria 
Details  • pregnant women
• nursing mothers
• pre-existing cardiac disease
• uncontrolled hypertension
• uncontrolled diabetes mellitus
• Autoimmune diseases
• Bleeding disorders
• Pulmonary fibrosis
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
change in pigmentation, vascularity, pliability and height of lesion using Vancouver’s scar scale.Score is based on the four parameters: pigmentation, vascularity, pliability and height of lesion. Total score is of 13. Pigmentation, vascularity and pliability will be assessed subjectively and the height is measured using vernier callipers.   every 3 weeks (at 0, 3, 6, 9, 12 and 15 weeks). 
 
Secondary Outcome  
Outcome  TimePoints 
Scale for patient self assessment of scar,, photograph evaluation and global evaluation. Patient self assessment scar Scale is consisted of six parameters: pain, itching, colour, stiffness, thickness, and psychological discomfort. Total score is of 18.   every 3 weeks (at 0, 3, 6, 9, 12 and 15 weeks). 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/03/2011 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This study is a randomized, open label, prospective, parallel group, single-centre  trail comparing the safety and efficacy of Sixteen intralesional injection of Inj.5-fluorouracil (50mg/ml) 0.9ml + inj. Triamcinolone acetonide(10mg/ml) 0.1ml will be given intralesionally weekly for 15 weeks in insulin syringe and upto 0.2ml of drug will be infiltrated till mild blanching occurs and Six intralesional injections, by tattooing method with insulin syringe 40 punctures/5 mm2 of Inj. Bleomycin (1.5mg/ml) given at 3 weekly for 15 weeks in 60 patients with keloids and hypertrophic scars ( 30 in each group) .study is being conducted at Sir. T. Hospital, Bhavnagar. The primary outcome measures is based on Vancouver scoring scale at every 3 weeks ( at 0, 3, 6, 9, 12 and 15 weeks). Score is based on the four parameters: pigmentation, vascularity, pliability and height of lesion. Total score is of 13. Pigmentation, vascularity and pliability will be assessed subjectively and the height is measured using vernier callipers.  The secondary outcomes is based on the scale for the patient self assessment scar scale, photograph evaluation and global evaluation. Patient self assessment scar Scale is consisted of six parameters: pain, itching, colour, stiffness, thickness, and psychological discomfort. Total score is of 18. This scale will be taken at every 3 weeks (at 0, 3, 6, 9, 12 and 15 weeks).

Adverse events will be monitored throughout the study period during each visit by Clinical evaluation for the development of dermal atrophy, skin pigment changes, minor ulcerations, swelling, pain, erythema, telengiectasias, molting, anemia, leucopenia, thrombocytopenia, and pulmonary fibrosis; and Laboratory evaluation using Hematological parameters: Hb, TC, DC, RBC count, Platelet count, ESR; RBS; Renal function test: S.creatinine, B.urea; Liver function test: S.bilirubin SGPT, SGOT, ALP ) will be performed at the baseline and thereafter every 3 weeks up to 15 weeks. The chest X-ray will be taken at baseline and after 15 weeks.

 

 

 
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