fractional CO2 laser 10,600nm
Devicefractional CO2 laser 10,600nm session, every month for 4 months
NCT Number: NCT03460431
clinical comparative study comparing the effectiveness of fractional CO2, long pulsed Nd YAG and their combination in collagen remodeling in keloid clinically, biochemically and histopathologically
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All sexes
Interventional
Not applicable
Patients The study included 30 Egyptian patients with keloid scar recruited from the Out Patient Clinic, Dermatology Department, Cairo University.
Methodology
Patients:
Thirty patients were included in the study which is a clinical comparative study comparing the effectiveness of fractional CO2, long pulsed Nd YAG and their combination in collagen remodeling in keloid clinically in all the included patients and biochemically and immunohistochemically fifteen patient
Methods:
Assessment Assessment was done before treatment every session and one months after the final laser treatment. Clinical assessment was done for all patients while histopathological and biochemical assessment were done only in 15 patients.
A. Clinical evaluation Clinical assessment was fulfilled via calculating the scores of both the Vancouver Scar Scale; and the Patient and Observer Scar Assessment Scale. Patients were assessed every session, any side effects were reported, e.g pain, swelling, infection, hyper pigmentation or hypo pigmentation.
B. Histopathological and biochemical evaluation
Fifteen patients were randomly selected and subjected to the pre and post treatment biopsies :
Three mm punch skin biopsy was taken from the keloid (any lesion A, B, or C) before starting treatment sessions ●Post treatment biopsies: Each lesion (A, B, C) was biopsied separately (3 mm punch biopsy), one month after last treatment session.
Biopsies of controls ●parts of excess skin from 12 patients undergoing abdominoplasty were used as controls for levels of TGFβ1 and TGFβ3.
Procedure
Orcein stained sections were graded according to the grading criteria proved by Ozog et al. in 2013 for the appearance of the dermal elastic tissue as follows:
0 normal
Image analyzer evaluation (morphometric study):
The area percent of collagen and elastic fibres were quantitatively evaluated in Masson's trichrome and orcein stained sections respectively at magnification X100 in 5 non overlapping fields for all patients. Image analysis was done using Leica Qwin 500C image analyzer computer system (England) present in the Histology Department, Faculty of Medicine, Cairo University .
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
fractional CO2 laser 10,600nm session, every month for 4 months
Nd YAG laser1064 nm laser session, every month for 4 months
Time frame: 5 months
assessed by Patient and Observer Scar assessment Scale
Time frame: 5 months
assessed by Quantitative morphometric analysis using Leica Qwin 500 Image Analyzer (LEICA Imaging Systems Ltd, Cambridge, England) measuring area percent of collagen and elastin fibers in micrometer squared
Time frame: 5 months
assessed by level of transforming growth factor beta 1 and 3 using Human TGF-B ELISA kit provided by ID labs Biotechnology London, ON, Canada.measurement unit is nano gram per gram tissue
Cairo University
Other
Evaluation of Fractional CO2 and Non Ablative Long Pulsed Nd YAG Lasers Alone and in Combination in Treatment of Keloids
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