A clinical trial to study the effects of two drugs, 5-Fluorouracil and bleomycin in patients with keloids and hypertrophic scars.

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.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/11/004155

Enrollment

Registered

2013-11-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- keloids and Hypertrophic scars

Interventions

Intervention1: intralesional 5-fluorouracil with triamcinolone acetonide, intralesional Bleomycin: Study groups: study will be performed in two groups ( 30 patient in each group). In both the groups,

RBS

Renal function test: S.creatinine, B.urea

Liver function test: S.bilirubin, SGPT, SGOT, ALP ) and Chest X-ray will be done. Vancouver scar scale and scale for the patient self assessment scar will be applied. Patient will be ran

Eligibility

Inclusion criteria

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

Exclusion criteria: • pregnant women • nursing mothers • pre-existing cardiac disease • uncontrolled hypertension • uncontrolled diabetes mellitus • Autoimmune diseases • Bleeding disorders • Pulmonary fibrosis

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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

Measure	Time frame
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).	—

Countries

India

Contacts

Public ContactDr Mugdha Jhamwar

Government Medical College and Sir. T. Hospital, Bhavnagar.

dr_hitashah07@yahoo.co.in9429503188

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026