A clinical trial to study the effects of two drugs, 5-Fluorouracil and bleomycin in patients with keloids and hypertrophic scars.
- Conditions
- keloids and Hypertrophic scars
- Registration Number
- CTRI/2013/11/004155
- Lead Sponsor
- Government Medical College Bhavnagar
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
- 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.
•pregnant women •nursing mothers •pre-existing cardiac disease •uncontrolled hypertension •uncontrolled diabetes mellitus •Autoimmune diseases •Bleeding disorders •Pulmonary fibrosis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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).
Trial Locations
- Locations (1)
Sir. T. Hospital and Government Medical College, Bhavnagar
🇮🇳Bhavnagar, GUJARAT, India
Sir. T. Hospital and Government Medical College, Bhavnagar🇮🇳Bhavnagar, GUJARAT, IndiaDrMugdha JhamwarPrincipal investigator09099972972mugdha.jhamwar@gmail.com