Pilot Study of a Novel 532nm KTP Laser for the Treatment of Fresh Surgical Scars

Inclusion Criteria:

- Fitzpatrick Skin Type I - IV

- Has postoperative linear scar(s) which is one to twelve months post-surgery.

- Having one scar that measures a minimum of 5 cm in length or two scars (bilateral)
each measure a minimum of 2 cm in length.

- Be in good health.

- Must agree not to undergo any other procedure for the treatment of scar during the
study.

- Willing to refrain from excess sun exposure and willing to wear sunscreen on the
treated scar during the study (including the follow-up period).

- Post-menopausal or surgically sterilized, or using a medically acceptable form of
birth control at least 3 months prior to enrollment and during the entire course of
the study.

Exclusion Criteria:

- Participation in a study of another device or drug within 6 months prior to
enrollment or during the study.

- Having received any prior treatment for the target surgical scar.

- Pregnant and/or breastfeeding.

- Significant concurrent illness, malignant tumors in the target area, acute or chronic
skin infection/inflammation, currently using immunosuppressive medications or
currently undergoing systemic chemotherapy.

- Current use of any medication known to increase sensitivity to light or taking
prescription anticoagulation medication.

- History of abnormal or delayed wound healing, keloid formation or pigmentary
disorders, particularly tendency for hyper- or hypo-pigmentation.

- History of malignant skin disease, immune deficiency disorders, seizure disorders due
to light, or diseases stimulated by heat, unless prophylactic measures taken prior to
treatment.

- Systemic use of isotretinoin within 6 months or corticosteroids within 12 months of
study participation.

- Anytime in life, had used gold therapy (gold salts) for disorders such as
rheumatologic disease or lupus.

- Current smoker or history of smoking within 12 months of study participation.