The primary objective of this study is to assess the efficacy and safety of 10600 nm fractional laser therapy for the treatment of different types of scars.
ID
Source
Brief title
Condition
- Other condition
- Epidermal and dermal conditions
Synonym
Health condition
littekens
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Blinded Physicians Global Assessment is the main outcome variable.
Secondary outcome
Secondary variables are Patient*s Global Assessment, blinded clinical
assessment of the scar on a scale from 0-3 (erythema, pigmentation, texture,
hypertrophy, atrophy, pliability), Patient and Observer Scar Scale (POSAS),
objective colour measurements by reflectance spectroscopy (LAB) and chromameter
(erythema index, melanin index).
Background summary
Scars can be highly disfiguring and may result in functional impairment and
psychosocial problems. Recently, fractional laser therapy (FLT) has been
introduced as a promising novel treatment modality for both atrophic and
hypertrophic scars.
Study objective
The primary objective of this study is to assess the efficacy and safety of
10600 nm fractional laser therapy for the treatment of different types of
scars.
Study design
Prospective observer blinded randomized controlled split-lesion trial.
Intervention
A test region (at least 2x2cm but smaller than 5x5cm) will be treated three
times every four weeks with the UltraPulse Encore 10600nm Deep FX fractional
laser. First, the skin will be cleaned with chlorhexidin solution. Next, the
test region allocated to laser treatment will be locally anaesthetised by
infiltration with lidocaine 2%/epinephrine 1:80000. Post treatment care starts
directly after each treatment session and involves thrice daily application of
fucidic acid cream during 3 days.
Study burden and risks
Subjects participating in the study will be requested to visit the SNIP
(Amsterdam) 3 times for treatment and 2 times for follow-up. The time
investment per visit will be 30 minutes for treatment sessions and 20 minutes
for follow-up visits. Fractional laser therapy using a 10600 nm laser device is
a procedure with FDA approval for both the device (UltraPulse Encore 10600 nm)
and the indication (scar). Local side effects are erythema (always; 1-2 weeks),
oozing (often; 1-3 days), swelling (always, 1-4 days), blisters < 0.5cm
(occasionally) and blisters > 0.5cm (very rare). No systemic side effects are
known for this laser device.
The burden due to the study is moderate, side effects are generally local and
mild. Systemic side effects are not reported with this treatment. There is an
indirect benefit for the participating subject. In case of improvement of the
treated test regions, this therapy can be directly utilized to treat the whole
scar.
Meibergdreef 35
1105 AZ Amsterdam
NL
Meibergdreef 35
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Atrophic or hypertrophic scars allowing for demarcation of two similar test regions of at least 2x2 cm;
Age at least 18 years;
Subject is willing and able to give written informed consent;
Interval between injury and start of study at least one year.
Exclusion criteria
Suspected allergy to lidocaine;
Use of isotretinoin in the past 6 months;
Subjects not competent to understand what is involved;
Skin type V and VI
Pregnancy;
Concomitant skin disease at the site of treatment;
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31358.018.10 |