A clinical trial to study the effects of two drugs, 5-Fluorouracil and bleomycin in patients with keloids and hypertrophic scars.
Phase 4
Completed
- Conditions
- Health Condition 1: null- keloids and Hypertrophic scars
- Registration Number
- CTRI/2013/11/004155
- Lead Sponsor
- Government Medical College Bhavnagar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
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.
Exclusion Criteria
•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 Vancouverâ??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.Timepoint: 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.Timepoint: every 3 weeks (at 0, 3, 6, 9, 12 and 15 weeks).