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
|
|
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
|
|
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. |