Scars Clinical Trial
Official title:
1540nm Non Ablative Fractional Laser Treatment of Scars : a Prospective Single Blinded Within Patient Controlled Randomized Trial.
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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