Pilot Study of a Novel 532nm KTP Laser for the Treatment of Fresh Surgical Scars
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)|
|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.
|Endpoint classification||safety study|
|Intervention model||parallel assignment|
Cutera ExcelV 532nm KTP laser
Cynosure Cynergy 595nm pulsed-dye laser
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
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.
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