Bevacizumab Versus Triamcinolone Acetonide for the Treatment of Keloids.

Phase 4

Active, not recruiting

• Conditions: Keloids
• Interventions: Drug: Bevacizumab; Drug: Triamcinolone Acetonide

• Registration Number: NCT07014280
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

The study compares the efficacy and safety of intralesional bevacizumab versus corticosteroids for the treatment of keloids. Assessment will be done clinically by the use of Modified Vancouver Scar Scale. Erythema index will be measured by spectrophotometry. The levels of Vascular Endothelial Growth Factor, collagen type 1 and collagen type 3 in the lesions before and after each treatment modality.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Primary Completion: 2024-09-01
• Study First Submitted: 2025-05-16
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-02
• Last Update Submitted: 2025-06-02
• Study First Posted: 2025-06-10
• Last Update Posted: 2025-06-10
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Patients with keloids (post-traumatic, any site, any duration)
• Age >18 years
• Patients who didn't receive any treatment for the lesions in the past 6 weeks

Exclusion Criteria

• Patients who are pregnant, willing to get pregnant or lactating
• History of any liver or renal disease
• History of any cardiovascular disease
• History of hypertension
• History of thrombo-embolic events
• Known cases of bleeding disorders
• History of peptic ulcer
• Patients who underwent any surgeries in the last month

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intralesional bevacizumab injection	Bevacizumab	Intralesional bevacizumab injection for the treatment of keloid
Intralesional corticosteroid injection	Triamcinolone Acetonide	Intralesional triamcinolone acetonide injection for the treatment of keloids

Primary Outcome Measures

Name	Time	Method
Erythema Index	6 months	Evaluation of skin erythema index was done using a spectrophotometry device
Modified Vancouver scar scale (mVSS)	6 months	Six characteristics of the scar were assessed. These are: vascularity, height, pliability, and pigmentation, pain and pruritis. Each characteristic is given a score, which are added together to give an overall score between 0 and 18. Higher scores mean a worse outcome.
Vascular Endothelial growth factor (VEGF)	6 months	Tissue levels of VEGF, collagen type 1 and 3 measured by Enzyme linked immunosorbent assay
Collagen type 1 and 3	6 months	Tissue levels of collagen type 1 and 3 measured by Enzyme linked immunosorbent assay
Histopathological examination	6 months	Two mm punch biopsies were obtained per area at baseline and one month after the last treatment session. The post-treatment biopsy 3as taken from the vicinity of the baseline biopsy. Tissues are fixed in 10% buffered formalin, embedded in paraffin and sectioned into 5 μm-thick sections. Specimens were stained with hematoxylin and eosin (H\&E) and orcein (or demonstration of elastic fibers). Histological examination was carried out under a light microscopy. Assessment was done as follows: 1. Assessment of the collagen fibers will be done by examining H \& E slides, putting grading from 1 to 4 according to the thickness and orientation of the collagen fibers and the spaces in between the fibers.; 2. Assessment of the elastic fibers will be done through examining orcein stained specimens and grading the elastic fibers in the scars from 1 to 4 based on presence or absence of the elastic fiber and degree of degradation and fragmentation.

Trial Locations

Locations (1)

Kasr El Ainy University Hospital, faculty of medicine, Cairo university; 🇪🇬 Cairo, El Manial, Egypt