Bevacizumab Versus Triamcinolone Acetonide for the Treatment of Keloids.

NCT07014280 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: BevaVSsteroid:keloids
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Keloids

Outcome Measures

Primary Outcomes (5)

• Modified Vancouver scar scale (mVSS)

  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.

  6 months

• Erythema Index

  Evaluation of skin erythema index was done using a spectrophotometry device

  6 months

• Vascular Endothelial growth factor (VEGF)

  Tissue levels of VEGF, collagen type 1 and 3 measured by Enzyme linked immunosorbent assay

  6 months

• Collagen type 1 and 3

  Tissue levels of collagen type 1 and 3 measured by Enzyme linked immunosorbent assay

  6 months

• Histopathological examination

  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.

  6 months

Study Arms (2)

Intralesional bevacizumab injection

ACTIVE COMPARATOR

Intralesional bevacizumab injection for the treatment of keloid

Drug: Bevacizumab

Intralesional corticosteroid injection

ACTIVE COMPARATOR

Intralesional triamcinolone acetonide injection for the treatment of keloids

Drug: Triamcinolone Acetonide

Interventions

Bevacizumab DRUG

anti-VEGF

Intralesional bevacizumab injection

Triamcinolone Acetonide DRUG

corticosteroid

Intralesional corticosteroid injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr El Ainy University Hospital, faculty of medicine, Cairo university

Cairo, El Manial, 11956, Egypt

Location

MeSH Terms

Conditions

Keloid

Interventions

Bevacizumab; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: June 10, 2025
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: July 1, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)