Scars
Conditions
Brief summary
Scars are a frequent reason of consultation in a dermatological clinic. Their cosmetic aspect can play a key role in patient satisfaction and self-image. Non ablative fractional infra-red laser treatment is a new concept in the laser field using arrays of microscopic thermal damage patterns to stimulate a wound healing response. There are different reports on the positive effect of these type of laser treatment in the treatment of acne scarring, striae, rythides, hypopigmented and hypertrophic scars. The low morbidity of the treatment and the lack of satisfying treatment regimes for different types of scars makes it attractive to investigate the efficacy and safety of 4 treatment with the 1540nm non ablative fractional laser in the treatment of scars. Objectives: * To evaluate the efficacy of 4 laser treatments with Starlux 300 Lux 1540nm Fractional laser handpiece ( Palomar Medical Technologies ) 1 and 3 month after the last laser treatment for 3 different scar patient groups : 1. Patients with hypopigmented scars 2. Patients with hypertrophic scars 3. Patients with scars due to grafts and reconstructions in the head and neck region. * To evaluate the treatment related pain. on a categorical scale from 0-10 * To evaluate the adverse effect of 1540nm fractional laser versus untreated control in the 3 patient groups. The study design is a prospective single blinded randomised within-patient controlled study The study involves 6 visits.
Interventions
PROCEDURElaser treatment
Starlux 300 Lux 1540nm Fractional laser hand piece
PROCEDUREtreatment without laser
Starlux 300 Lux 1540nm Fractional laser hand piece
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The patients needs to have a scar fulfilling the inclusion and
Exclusion criteria
of one of the 3 patient groups: Patient group 1: patients with hypopigmented scars : Inclusion criteria: * Patients with a hypopigmented scar allowing 2 side by side test areas of similar sizes and appearance within the same anatomical region. * Skin type 1-4 * Age at least 18 years old * Willingness and ability to give written informed consent and to comply with the requirements of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy of 4 laser treatments with Starlux 300 Lux 1540nm Fractional handpiece (Palomar Medical Technologies) 1 and 3 months after the last laser treatment in 3 different scar patient groups | at 1 and 3 months |
| Evaluation of the treatment related pain | at 1 and 3 months |
| Evaluation of the adverse effect of 1540nm fractional laser versus untreated control site | at 1 and 3 months |
Secondary
| Measure | Time frame |
|---|---|
| patient assessment for the treated and control region | at 1 and 3 months after treatment |
| Evaluation of skin redness and pigmentation | at 1 and 3 months after treatment |
| Evaluation of histological difference in treated an non treated parts of the scar | at 3 months after treatment |
| Photografic documentation of scar improvement | at 1 and 3 months after treatment |
| Compare different clinical scar assessment tools that can be used in the evaluation of clinical efficacy of the laser treatment | at 1 and 3 months after treatment |
| Physician assessment for the treated and control region (PhGA) | at 1 and 3 months after treatment |
Countries
Belgium
Outcome results
None listed