Caesarean Scar Revision With the UltraPulse

Study Overview
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Brief Summary
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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.

Official Title
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Caesarean Scar Revision With the UltraPulse

Conditions
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Scar Revision

Intervention / Treatment
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* Device: Lumenis UltraPulse Encore.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females in good general health older than 22 years of age and younger than 55 years of age. Presenting with a caesarean scar mature and stable caesarean scar (at least 1 year post procedure). At least six months following termination of breast feeding. Willing to give and sign an informed consent form and a photographic release form. Willing to comply with study dosing and complete the entire course of the study . Performed negative pregnancy test. Exclusion Criteria: Active bacterial, fungal, or viral infection in the treatment area. Active cold sores, or herpes in the treatment area. Recent excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study . History of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis). Treatment with a systemic retinoid within the past year (e.g., Accutane®, Roche Dermatologics). History or presenting with a keloid scar. Any current or recent treatment for cancer. Any uncontrolled systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study. Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study. Previous laser treatments on the same scar at least 0.5 year prior to this evaluation. Subject planning any other cosmetic procedure to the study area during the study period, other than the treatments that will be performed by the investigator . Any other condition that may exclude patient for treatment per physician discretion. Female subject who is pregnant, nursing an infant .

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scar Revision<br>Caesarean Scar Revision using Lumenis UltraPulse Encore. | Device: Lumenis UltraPulse Encore.<br>* Treatment using Lumenis UltraPulse Encore.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar Evaluation | VSS , POSAS, Appearance assessment-Evaluation of the scar by blinded investigator. | 3 month following the 3rd treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar Evaluation. | VSS assessment -Evaluation of the scar by blinded investigator. | 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 | 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. | 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. | 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 | Immediately before the 2nd, and 3rd treatment | 
| Subject's satisfaction | Subject's satisfaction of the treatment using a Satisfaction Scale as follows: None; Slight; Moderate; Good; Very Good. | At the 3rd treatment and at the 1, 3 and 6 month follow-up |