Clinical trial NCT01056211: 1540nm Non Ablative Fractional Laser Treatment of Scars
Official title: 1540nm Non Ablative Fractional Laser Treatment of Scars : a Prospective Single Blinded Within Patient Controlled Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Scars
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2010-01-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Exclusion criteria:

* Pregnancy and lactation
* Oral retinoid drugs within the past 6 months

Patientgroup 2: patients with hypertrophic scars :

Inclusion criteria:

* Patients with a hypertrophic scar allowing 2 side by site test areas of similar sizes and appearance within the same anatomical region.
* Skin type 1-4
* Male / Female
* Age at least 18 years old
* Willingness and ability to give written informed consent and to comply with the requirements of the protocol

Exclusion criteria:

* Pregnancy and lactation
* Oral retinoid drugs within the past 6 months

Patient group 3: Patients with scars due to grafts and reconstructions in the head and neck region.

Inclusion criteria:

* Patients with a graft or reconstruction with 2 site by site test areas of similar sizes and appearance within the same anatomical region (head and neck 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

Exclusion criteria:

* Pregnancy and lactation
* Oral retinoid drugs within the past 6 months

Primary outcomes:
measure: 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
timeFrame: at 1 and 3 months
measure: Evaluation of the treatment related pain
timeFrame: at 1 and 3 months
measure: Evaluation of the adverse effect of 1540nm fractional laser versus untreated control site
timeFrame: at 1 and 3 months
Secondary outcomes:
measure: Evaluation of skin redness and pigmentation
timeFrame: at 1 and 3 months after treatment
measure: Compare different clinical scar assessment tools that can be used in the evaluation of clinical efficacy of the laser treatment
timeFrame: at 1 and 3 months after treatment
measure: Physician assessment for the treated and control region (PhGA)
timeFrame: at 1 and 3 months after treatment
measure: patient assessment for the treated and control region
timeFrame: at 1 and 3 months after treatment
measure: Photografic documentation of scar improvement
timeFrame: at 1 and 3 months after treatment
measure: Evaluation of histological difference in treated an non treated parts of the scar
timeFrame: at 3 months after treatment
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Univerisity Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Evelien Verhaeghe, MD
role: PRINCIPAL_INVESTIGATOR
References: