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.
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
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 group | Role | What they receive |
|---|---|---|
| Intralesional bevacizumab injection | Active comparator | Intralesional bevacizumab injection for the treatment of keloid Receives: Drug: Bevacizumab |
| Intralesional corticosteroid injection | Active comparator | Intralesional 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.
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
Erythema Index
Evaluation of skin erythema index was done using a spectrophotometry device
Measured: 6 months
Vascular Endothelial growth factor (VEGF)
Tissue levels of VEGF, collagen type 1 and 3 measured by Enzyme linked immunosorbent assay
Measured: 6 months
Collagen type 1 and 3
Tissue levels of collagen type 1 and 3 measured by Enzyme linked immunosorbent assay
Measured: 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:
- 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.
- 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.
- First posted10 Jun 2025
- Study start1 Sep 2023
- Primary completion1 Sep 2024
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KeloidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana F Hilal, MD, Kasr El Aini Hospital
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