Dermato-venerologisk Afdeling D42
Copenhagen, Bispebjerg Bakke 23, 2400, Denmark
NCT Number: NCT02050126
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.
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Notify Me22 year–55 year
Female
Interventional
Not applicable
Copenhagen, Bispebjerg Bakke 23, 2400, Denmark
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Treatment using Lumenis UltraPulse Encore.
Time frame: 3 month following the 3rd treatment.
VSS , POSAS, Appearance 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
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 by blinded Investigator and subject
Time frame: At base line, at the 3rd treatment and at the 1, 3 and 6 months follow-up
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.
Colorimeter will be used for color measurement.
Time frame: Immediately before the 2nd, and 3rd treatment
Histochemical analysis of scar tissue with different staining for analysis of changes following treatment:
Time frame: At the 3rd treatment and at the 1, 3 and 6 month follow-up
Subject's satisfaction of the treatment using a Satisfaction Scale as follows: None; Slight; Moderate; Good; Very Good.
Lumenis Be Ltd.
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.