This trial is active, not recruiting.

Conditions scar, surgical scar, cicatrix, cicatrix, hypertrophic, keloid
Treatments 532nm potassium titanyl phosphate (ktp) laser, 595nm pulsed-dye laser (pdl)
Phase phase 4
Sponsor Cutera Inc.
Start date February 2013
End date May 2014
Trial size 20 participants
Trial identifier NCT01789346, C-12-EV3


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Cutera ExcelV 532nm KTP laser
532nm potassium titanyl phosphate (ktp) laser ExcelV laser
(Active Comparator)
Cynosure Cynergy 595nm pulsed-dye laser
595nm pulsed-dye laser (pdl) Cynosure Cynergy

Primary Outcomes

Comparison of percentage improvement in surgical scar between treatment (532nm KTP laser) and active control (595nm PDL) treatment arms.
time frame: 12-weeks post-final laser treatment

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Cutera Inc..