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KeloidsPhase 4NCT07014280

Bevacizumab Versus Triamcinolone Acetonide for the Treatment of Keloids.

A Phase 4 study testing Bevacizumab and Triamcinolone Acetonide in people with Keloids, run by Kasr El Aini Hospital at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Keloids
What is being tested?
Bevacizumab and Triamcinolone Acetonide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteEgypt
Study dates
1 Sep 2023to 1 Jul 2025
Phase
Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Kasr El Ainy University Hospital, faculty of medicine, Cairo university

    Cairo, El Manial, 11956

Other trials in Egypt

About this study

Official title: Efficacy of Intralesional Bevacizumab Versus Intralesional Triamcinolone Acetonide Injection in the Treatment of Keloids.

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
Being tested
Bevacizumab, Triamcinolone Acetonide
Medical subject headings
Keloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabDrug

    anti-VEGF

  • Triamcinolone AcetonideDrug

    corticosteroid

Study groups in NCT07014280
Study groupRoleWhat they receive
Intralesional bevacizumab injectionActive comparatorIntralesional bevacizumab injection for the treatment of keloid
Receives: Drug: Bevacizumab
Intralesional corticosteroid injectionActive comparatorIntralesional triamcinolone acetonide injection for the treatment of keloids
Receives: Drug: Triamcinolone Acetonide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. Erythema Index

    Evaluation of skin erythema index was done using a spectrophotometry device

    Measured: 6 months

  3. Vascular Endothelial growth factor (VEGF)

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

    Measured: 6 months

  4. Collagen type 1 and 3

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

    Measured: 6 months

  5. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2025
  2. Study start1 Sep 2023
  3. Primary completion1 Sep 2024
  4. Study completion1 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07014280
Sponsor's protocol ID
BevaVSsteroid:keloids
Status last verified
Jun 2025
First submitted
16 May 2025
Last updated
10 Jun 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hilal RF, Osama N, El-Tahlawi S, Elbendary A, Nour ZA, Ragab N. Efficacy of Intralesional Bevacizumab Versus Intralesional Triamcinolone Acetonide Injection in the Treatment of Keloids: A Randomized Clinical Trial. Int J Dermatol. 2026 Jun 28. doi: 10.1111/ijd.70548. Online ahead of print.

    PubMed 42365524

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