Keloids
Conditions
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.
Interventions
DRUGBevacizumab
anti-VEGF
DRUGTriamcinolone Acetonide
corticosteroid
Sponsors
Kasr El Aini Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Erythema Index | 6 months | Evaluation of skin erythema index was done using a spectrophotometry device |
| 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. |
Countries
Egypt
Outcome results
None listed