Ten (10) adult female subjects that had a caesarean surgery performed.Study will be conducted in 1 site. Each subject will receive three treatments on one area that was randomly chosen. The other area will be left untreated and will serve as a control. The objective is to Evaluate the clinical impact of UltraPulse fractional carbon dioxide laser treatment on the appearance of a Caesarean Scar (CS) as compared to a similar untreated scar side.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Treatment using Lumenis UltraPulse Encore.
Dermato-venerologisk Afdeling D42
Copenhagen, Bispebjerg Bakke 23, Denmark
Scar Evaluation
VSS , POSAS, Appearance assessment-Evaluation of the scar by blinded investigator.
Time frame: 3 month following the 3rd treatment.
Scar Evaluation.
VSS assessment -Evaluation of the scar by blinded investigator.
Time frame: At base line , at the 3rd treatment and at the 1, 3 and 6 months follow-up
POSAS assessment
POSAS assessment by blinded Investigator and subject
Time frame: At base line , at the 3rd treatment and at the 1, 3 and 6 months follow-up
Scar Thickness and Uniformity
A High Definition Ultrasound (US) device will be used to generate a high resolution image of the skin layers of the treated and non-treated scar in order to measure and compare changes in scar thickness and uniformity.
Time frame: At base line, at the 3rd treatment and at the 1, 3 and 6 months follow-up
Scar color
Colorimeter will be used for color measurement.
Time frame: At base line, at the 3rd treatment and at the 1, 3 and 6 months follow-up.
Histochemical Changes in scar tissue
Histochemical analysis of scar tissue with different staining for analysis of changes following treatment: * H\&E staining and histology for collagen arrangement, epidermal rete ridges and measurement of scar depth * Collagen type I and III staining * Elastin staining * Immunohistochemistry for TGF-beta 1, 2, 3 and MMPs
Time frame: Immediately before the 2nd, and 3rd treatment
Subject's satisfaction
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Subject's satisfaction of the treatment using a Satisfaction Scale as follows: None; Slight; Moderate; Good; Very Good.
Time frame: At the 3rd treatment and at the 1, 3 and 6 month follow-up