Ablative 10600 nm fractional laser for the treatment of scars

• Conditions: littekens; cicatrix; scar; 10014982

• Registration Number: NL-OMON35000
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

Atrophic or hypertrophic scars allowing for demarcation of two similar test regions of at least 2x2 cm;
Age at least 18 years;
Subject is willing and able to give written informed consent;
Interval between injury and start of study at least one year.

Exclusion Criteria

Suspected allergy to lidocaine;
Use of isotretinoin in the past 6 months;
Subjects not competent to understand what is involved;
Skin type V and VI
Pregnancy;
Concomitant skin disease at the site of treatment;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Blinded Physicians Global Assessment is the main outcome variable. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary variables are Patient*s Global Assessment, blinded clinical<br /><br>assessment of the scar on a scale from 0-3 (erythema, pigmentation, texture,<br /><br>hypertrophy, atrophy, pliability), Patient and Observer Scar Scale (POSAS),<br /><br>objective colour measurements by reflectance spectroscopy (LAB) and chromameter<br /><br>(erythema index, melanin index).</p><br>