1540nm Non Ablative Fractional Laser Treatment of Scars

Scars Clinical Trial

Official title:

1540nm Non Ablative Fractional Laser Treatment of Scars : a Prospective Single Blinded Within Patient Controlled Randomized Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056211
• Other study ID #: 2009/626
• Status: Completed
• Phase: Phase 4
• First received: January 25, 2010
• Last updated: December 4, 2014
• Start date: January 2010
• Est. completion date: August 2013

Study information

• Verified date: December 2014
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scars

Intervention

Procedure:
• laser treatment
Starlux 300 Lux 1540nm Fractional laser hand piece
• treatment without laser
Starlux 300 Lux 1540nm Fractional laser hand piece
• laser treatment
Starlux 300 Lux 1540nm Fractional laser hand piece

Locations

Country	Name	City	State
Belgium	Univerisity Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Evaluation of the treatment related pain		at 1 and 3 months	Yes
Primary	Evaluation of the adverse effect of 1540nm fractional laser versus untreated control site		at 1 and 3 months	Yes
Secondary	Evaluation of skin redness and pigmentation		at 1 and 3 months after treatment	No
Secondary	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	No
Secondary	Physician assessment for the treated and control region (PhGA)		at 1 and 3 months after treatment	No
Secondary	patient assessment for the treated and control region		at 1 and 3 months after treatment	No
Secondary	Photografic documentation of scar improvement		at 1 and 3 months after treatment	No
Secondary	Evaluation of histological difference in treated an non treated parts of the scar		at 3 months after treatment	No