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Ablative 10600 nm fractional laser for the treatment of scars

Ablative 10600 nm fractional laser for the treatment of scars - Fractional laser in scars

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35000
Enrollment
25
Registered
2010-05-18
Start date
2010-04-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

littekens cicatrix scar

Interventions

A test region (at least 2x2cm but smaller than 5x5cm) will be treated three times every four weeks with the UltraPulse Encore 10600nm Deep FX fractional laser. First, the skin will be cleaned with c

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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;

Design outcomes

Primary

MeasureTime frame
Blinded Physicians Global Assessment is the main outcome variable.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)