Fractionated Carbon Dioxide Laser and Burn Scar Contractures: Evaluation of Post-Treatment Scar Function and Appearance

The primary goal of the study will analyze whether the fractionated carbon dioxide laser can
improve other subjective and objective qualities of hypertrophic and/or contracted burn scars
with or without involvement of nearby mobile joints.

The investigators hypothesize that fractionated carbon dioxide laser therapy will increase
range of motion and improve tissue compliance in all scars overlying a mobile joint that has
been limited due to burn scar contracture. In addition, the investigators will evaluate the
effect of fractionated carbon dioxide laser therapy on common sequelae of hypertrophic and/or
contracted burn scars.

Inclusion Criteria:

- Healthy males and females between 5 and 70 years of age with hypertrophic and/or
contracted burn scars with or without involvement of mobile joints. The burn scars
must have occurred at least 1 year prior to the date of enrollment.

- Having suitable areas of treatment: All wounds in the area of interest must be closed
for at least two months, and the scars must be deemed stable for a period of 3 months
before initiation of treatment.

- Fitzpatrick skin types I-VI

- Able and willing to comply with all visit, treatment and evaluation schedules and
requirements

- Able to understand provide written informed consent

- Women of child-bearing age are required to be using a reliable method of birth control
at least three months prior to study enrollment and throughout the course of the
study.

Exclusion Criteria:

- Pregnant, intending to become pregnant during the course of the study, less than three
months postpartum or less than six weeks after completion of breastfeeding.

- Active tanning, including the use of tanning booths, during the course of the study

- Showing symptoms of hormonal disorders (i.e.: uncontrolled thyroid disease or
Polycystic Ovary Syndrome), as per the Investigator's discretion

- Abnormal photosensitivity due to metabolic disorder or due to use of external agents,
(drugs, herbs, etc.) within 2 weeks of initial treatment or during the course of the
study, except for use of aminolevulinic acid(Levulan®) which requires a washout period
of three months

- Prior use of retinoids in treated areas within three months of initial treatment or
during the course of the study

- Use of oral isotretinoin (Accutane®) within nine months of initial treatment or during
the course of the study. Note: skin must retain its normal degree of moisture prior to
treatment

- Prior skin treatment with laser or other devices in the treated area within three
months of initial treatment or during the course of the study

- Adverse reactions to compounds of any external agent (e.g., gels, lotions or
anesthetic creams) required for use in the study, if no alternative to the said agent
exists

- History of collagen vascular disease

- Concurrent inflammatory skin conditions, including, but not limited to, rosacea of any
severity

- Active Herpes Simplex at the time of treatment or having experienced more than three
episodes of Herpes Simplex eruption within a year of study enrollment

- Multiple dysplastic nevi in area to be treated

- Having a bleeding disorder or taking anticoagulation medications, including heavy use
of aspirin, in a manner which does not allow for a minimum 10 day washout period prior
to each treatment (as per the patient's physician discretion)

- History of immunosuppression/immune deficiency disorders (including human
immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) or
use of immunosuppressive medications

- Having any form of active cancer at the time of enrollment and during the course of
the study

- Significant concurrent illness, such as uncontrolled diabetes, (i.e., any disease
state that in the opinion of the Investigator would interfere with the anesthesia,
treatment, or healing process)

- Mentally incompetent, prisoner or evidence of active substance or alcohol abuse

- Any condition which, in the Investigator's opinion, would make it unsafe (for the
subject or study personnel) to treat the subject as part of this research study

- If it is determined that the contracture is due to a deeper process involving the
muscles, ligaments or bones.