littekens cicatrix scar
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Blinded Physicians Global Assessment is the main outcome variable. | — |
Secondary
| Measure | Time 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