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

Cutera

Status

Completed

Conditions

Keloid

Cicatrix

Surgical Scar

Cicatrix, Hypertrophic

Scar

Treatments

Device: 595nm PDL

Device: 532nm KTP

Study type

Interventional

Funder types

Industry

Identifiers

NCT01789346

C-12-EV03

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of the 532nm potassium titanyl phosphate (KTP) laser in comparison with the 595nm pulsed-dye laser (PDL) for the treatment of fresh surgical scars.

Full description

Randomized, Controlled, Open-Label Pilot Study of a Novel 532 nm KTP Laser for the Treatment of Fresh Surgical Scars. This is a single-center prospective, randomized, open-label, pilot study of a novel 532 nm KTP Laser in comparison with the 595nm pulsed-dye laser (PDL) in up to 20 subjects who have had a fresh surgical scar acquired within one to twelve months of the screening visit.

Enrollment

20 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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).
Able to read, understand and sign the Informed Consent Form.
Willing and able to adhere to the treatment and follow-up schedule, and the post-treatment care instructions.
Willingness to have digital photographs taken of the treated scar.
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, coagulation 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.