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Active, not recruitingNCT07014280Updated Jun 10, 2025

Bevacizumab Versus Triamcinolone Acetonide for the Treatment of Keloids.

A Phase 4 interventional study of Bevacizumab and Triamcinolone Acetonide in Keloids, sponsored by Kasr El Aini Hospital. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-10.

Sponsored by Kasr El Aini Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Sep 2023, registered May 2025).
Phase
Phase 4
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Keloids

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03

In context

Keloid

138 studies on the registry are indexed under Keloid; 26 are open to participants now.

This study's enrollment of 28 is close to the median of 30 across 109 interventional studies indexed under Keloid.

Browse Keloid studies →

Lead sponsor

Kasr El Aini Hospital is the lead sponsor of 287 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
28 participants (actual)

Study arms

  • Active comparator
    Intralesional bevacizumab injection

    Intralesional bevacizumab injection for the treatment of keloid

    Drug: Bevacizumab

  • Active comparator
    Intralesional corticosteroid injection

    Intralesional triamcinolone acetonide injection for the treatment of keloids

    Drug: Triamcinolone Acetonide

Interventions

06

What researchers measure

Primary outcomes

  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.

    Time frame: 6 months

  2. Erythema Index

    Evaluation of skin erythema index was done using a spectrophotometry device

    Time frame: 6 months

  3. Vascular Endothelial growth factor (VEGF)

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

    Time frame: 6 months

  4. Collagen type 1 and 3

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

    Time frame: 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.

    Time frame: 6 months

07

Study locations

1 site
  • Kasr El Ainy University Hospital, faculty of medicine, Cairo university
    Cairo, El Manial 11956, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2023 to primary completion in Sep 2024, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 16, 2025
First posted
Jun 10, 2025
StartActual
Sep 1, 2023
Primary completionActual
Sep 1, 2024
CompletionEst.
Jul 1, 2025
Last update
Jun 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07014280
Responsible party
Rana F Hilal, MD (Assistant professor, Kasr El Aini Hospital) — Principal investigator
First posted
Jun 10, 2025
Start date
Sep 1, 2023
Primary completion
Sep 1, 2024
Completion
Jul 1, 2025 (estimated)
Last update
Jun 10, 2025

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Bevacizumab · Triamcinolone Acetonide

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