1540nm Non Ablative Fractional Laser Treatment of Scars

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 4

Conditions: Scars

Treatments: Procedure: laser treatment; Procedure: treatment without laser

Study type: Interventional

Funder types: Other

Identifiers

NCT01056211

2009/626

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 6 patient groups, including a placebo group

hypopigmented scars treated with laser

Active Comparator group

Description:

patients with hypopigmented scars treated with Starlux 300 Lux 1540nm Fractional laser hand piece

Treatment:

Procedure: laser treatment

Procedure: laser treatment

hypopigmented scars treated without laser

Placebo Comparator group

Description:

patients with hypopigmented scars treated without laser

Treatment:

Procedure: treatment without laser

hypertrophic scars treated with laser

Active Comparator group

Treatment:

Procedure: laser treatment

Procedure: laser treatment

hypertrophic scars not treated with laser

Placebo Comparator group

Treatment:

Procedure: treatment without laser

scars due to grafts and reconstructions treated with laser

Active Comparator group

Description:

scars due to grafts and reconstructions in the head and neck region

Treatment:

Procedure: laser treatment

Procedure: laser treatment

grafts and reconstructions scars not treated with laser

Placebo Comparator group

Description:

scars due to grafts and reconstructions in the head and neck region

Treatment:

Procedure: treatment without laser